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Physical fitness in older women with osteoporosis and vertebral fracture after a resistance and balance exercise programme: 3-month post-intervention follow-up of a randomised controlled trial

Physical fitness in older women with osteoporosis and vertebral fracture after a resistance and... Background: Exercise is recommended for individuals with vertebral fractures, but few studies have investigated the effect of exercise on outcomes of importance for this population. Post-intervention effects of exercise are even less studied. The objective of this study was to evaluate habitual walking speed and other health-related outcomes after cessation of a 3-month exercise intervention. Methods: This follow-up study was conducted 3 months post-intervention of a randomised controlled trial. A total of 149 community-dwelling Norwegian women aged 65 years or older, diagnosed with osteoporosis and vertebral fracture were randomised into either exercise or control group. Primary outcome was habitual walking speed at 3 months. Secondary outcomes were other measures of physical fitness – including the Four Square Step Test (FSST), functional reach, grip strength and Senior Fitness Test – measures of health-related quality of life and fear of falling. Herein we report secondary data analysis of all outcomes at 6 months (3 months post-intervention). Data were analysed according to the intention-to- treat principle, linear mixed regression models were employed. Results: For the primary outcome, habitual walking speed, there was no statistically significant difference between groups (0.03 m/s, 95%CI − 0.02 to 0.08, p = 0.271) at the 3-month post-intervention follow-up. For secondary outcomes of physical fitness, statistically significant differences in favour of the intervention group were found for balance using the FSST (− 0.68 s, 95%CI − 1.24 to − 0.11, p = 0.019), arm curl (1.3, 95%CI 0.25 to 2.29, p = 0.015), leg strength using the 30-s sit to stand (1.56, 95%CI 0.68 to 2.44, p = 0.001) and mobility using the 2.45-m up and go (− 0.38 s, 95%CI − 0.74 to − 0.02, p =0.039). There was a statistically significant difference between the groups regarding fear of falling in favour of the intervention group (− 1.7, 95%CI − 2.97 to − 0.38, p = 0.011). No differences between groups were observed for health-related quality of life. Conclusion: The results show the improved effects of a multicomponent exercise programme on outcomes like muscle strength, balance and mobility as well as fear of falling in a group of older women with osteoporosis and vertebral fracture 3 months post-intervention. Trial registration: ClinicalTrials.gov Identifier: NCT02781974. Registered 25.05.16. Retrospectively registered. Keywords: Osteoporosis, Vertebral fracture, Exercise, Physical fitness, Short-term effects * Correspondence: bsugland@oslomet.no Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 2 of 11 Background older women with osteoporosis and vertebral fracture. Vertebral fractures are among the most common fragility However, there was no effect immediately post- fractures caused by osteoporosis [1, 2]. In the European intervention on habitual walking speed and HRQoL. It is Union in 2010, there were 3.5 million new fragility frac- important to evaluate whether effects of exercise on tures, and 520,000 of them were vertebral fractures [2]. muscle strength, balance and fear of falling would be sus- These numbers are likely an underestimate, as only about tained upon cessation of the intervention and whether two-thirds of vertebral fractures come to clinical attention there would be changes in habitual walking speed or QoL [3]. The risk of new vertebral fractures increases with the at follow-up. Thus, the aim of the current study was to number and severity of prevalent vertebral fractures [3]. examine the changes to habitual walking speed and other Vertebral fractures are associated with increased mortality health-related outcomes after cessation of a 3-month and morbidity [3, 4] and contribute to back pain, impaired exercise intervention compared to a control group. physical function and lower health-related quality of life (HRQoL) [5–8]. Methods Clinical practice guidelines for the management of We conducted a single-blinded randomised controlled osteoporosis emphasise the importance of exercise [9, 10]. trial with two arms, with participants allocated to the con- There is evidence that exercise prevents falls in older trol or intervention group in a 1:1 ratio. A computer- people [11]. Exercise can improve physical function, activ- generated permuted block randomisation scheme pro- ities of daily living and HRQoL in older people who are vided by a statistician was used to allocate the participants. frail [12]. However, individuals with vertebral fractures re- The scheme was kept and administered by a person not quire exercise that is tailored to address safety and related involved with the study participants and was unavailable impairments [13]. A recently updated systematic review to others. The block sizes varied from four to eight. on the effect of exercise for people with vertebral fracture The intervention group attended a resistance and balance [14] concluded that there is moderate-quality evidence exercise programme twice weekly for 12 weeks. The control that exercise improves physical performance. However, group was asked to live life as usual [24, 25]. In the period few studies have evaluated whether the effects of exercise from the end of intervention to the 3-month follow-up, all are sustained after the intervention has ceased [15–18]. participants were instructed to live life as usual. That meant The results from a limited number of studies examining continuing with their usual activities and maintaining their follow-up after cessation of exercise in older women with usual level of physical activity. The present study reports on osteoporosis and vertebral fracture were promising. In follow-up measurements performed 3 months after com- these individual studies (ranging from 12 weeks to 12 pleting the intervention or control activities (6 months months of follow-up), the sustained effects of exercise post-randomisation). Detailed information on the study were reported on QoL [16]; maximum walking speed, protocol is reported elsewhere [25]. Reporting follows the mobility and HRQoL [15]; functional leg muscle strength CONSORT 2010 statement [26], and a CONSORT check- [18]; and fear of falling [17]. list is provided in the Supplementary Files.The studywas Understanding whether the effects of an exercise inter- approved by the Regional Committee for Medical Research vention persist after cessation is important for several Ethics in South East Norway (Ref. 2014/2050) and is reasons. Sustaining adherence to exercise and thus any registered with Clinical Trials (NCT02781974). benefits from supervised resistance training is difficult without the support and help of staff [19]. The natural Settings and participants decline in physical fitness caused by aging may counter- The study was conducted both at facilities at Oslo act the gains from an exercise intervention if it is not Metropolitan University in Oslo, Norway and at a maintained. Muscle strength gained after an intervention physiotherapy clinic near Oslo. Recruitment of partici- is often lost or decreased in older people after a period pants was done from outpatient clinics for osteoporosis of detraining [20]. Similarly, improvements in balance in at two different public hospitals and a private speciality older adults may also be lost after detraining [21–23]. outpatient clinic in or nearby Oslo. The recruitment Conversely, it is possible that participating in an exercise period was from January 2016 to April 2018, with the intervention may motivate some participants to maintain last follow-up test completed in October 2018. The exercise outside of the trial to preserve the benefits or recruitment ended once the desired number of partici- see continued improvements. pants was reached. All patients provided written We have previously reported on a randomised con- informed consent prior to baseline testing. trolled trial [24] of a multicomponent exercise programme The inclusion criteria were female sex, age 65 years or informed by exercise recommendations for people with older, community dwelling and a diagnosis of osteoporosis osteoporotic vertebral fracture [13]. In that study, exercise defined as a T score ≤− 2.5 SD at the femoral neck or improved muscle strength, balance and fear of falling in lumbar spine verified by dual X-ray absorptiometry Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 3 of 11 (DXA). To be included, the participants had to have at population. Information about walking and time spent least one prevalent vertebral fracture classified as grade 1, sitting (measured by the International Physical Activity 2 or 3 by the Genant method [3] or verified by DXA- Questionnaire Short Form [IPAQ-SF]), afraid of falling based vertebral fracture assessment or via X-ray by med- (yes/no) and pain level in the previous week (measured ical doctors not involved in the study. Further, participants by NPRS) was collected at the intervention end and at had to be able to walk independently with or without a the 3-month follow-up. walking aid and able to speak and understand Norwegian. Exclusion of potential participants were done if they had Primary outcome known medical contraindications for exercising, such as The primary outcome of the original trial was physical severe lung diseases or progressive neurological disorders. fitness measured by 10-m habitual walking speed. Partic- ipants were instructed to walk 10-m from a static start Intervention at a comfortable pace (self-selected speed) [29]. This was The intervention was a group-based resistance and bal- repeated three times, and the average speed in metres ance circuit programme instructed by an experienced per second was calculated. physiotherapist. The design of the programme was in- formed by recommendations for exercising for people Secondary outcomes with osteoporosis and vertebral fracture [13] and from ex- Secondary outcomes were measures of physical fitness ercise recommendations for older people [27]. The inter- (balance, muscle strength and endurance), HRQoL and vention focused on weight-bearing exercises to improve the Falls Efficacy Scale International (FES-I). muscle strength and balance as well as strengthening exer- cises for the back extensors and upper arm muscles. Physical fitness Each exercise session lasted 1 h and consisted of two The Four Square Step Test (FSST) [30] and func- rounds of eight different strength and balance exercises tional reach (FR) [31] were used to assess balance. performed in a circuit, with a short warm-up before the FSST is a dynamic balance test [30]and is shownto circuit and closing with flexibility and stretching. The be valid and reliable when used to test community- group had up to eight participants, and safety consider- dwelling elderly adults. A cut-off score of 15 s dis- ations were a priority both when designing the programme criminates between multiple fallers (over 15 s) and and during each session. The experienced physiotherapist non-multiple fallers, with a sensitivity of 85% and a was responsible for adjustments and progression of the ex- specificity of 88–100% [30]. FR is a reliable and valid ercises for each participant throughout the exercise period. measure of balance [31] that measures the capacity The exercise goal was moderate intensity, corresponding to reach forward in an anticipatory postural adjust- to 8–12 repetitions for each exercise and a perceived level ment task [32]. Grip strength was measured with a of exertion of 13 to 14 on the Borg Rating of Perceived Ex- hydraulic handheld dynamometer [33]. Handgrip ertion scale [28]. The intervention is described in more de- strength is a simple and reliable test for the assess- tail elsewhere [24, 25] and in Supplementary File 2. ment of muscle status in older adults [33–35]. Indi- The participants allocated to the control group were vidual tests from the validated Senior Fitness Test instructed to live life as usual, which meant continuing were also applied: lower extremity leg strength (30-s with their usual everyday life and level of physical activ- sit to stand [30STS]), mobility (2.45-m up and go), ity during the study period. Participants in the control upper arm strength (number of arm curls in 30 s group were offered to take part in the exercise with a 2.3-kg [5-lb] weight) and functional endur- programme after their last follow-up assessment at 6 ance (6-min walk test [6MWT]). The Senior Fitness months post-randomisation. Test is a valid and reliable test for physical fitness in older people and consists of several tests that assess Outcome measures underlying physical components associated with Trained physiotherapists, blinded to group allocation, mobility [36]. assessed the outcome measures at baseline, at the inter- vention end (3 months) and at the 3-month follow-up HRQoL (6 months). Background information such as age, edu- The 36-item Short Form Health Survey (SF-36) [37] cation, body mass index, smoking status, medication, is a generic instrument for measuring HRQoL, found comorbidities, living alone or not, afraid of falling or to be valid and reliable in the general older popula- not, injuries caused by falls, taking analgesics (yes/no), tion [38]. It is divided into physical and mental com- physical activity and pain level in the previous week ponents based on eight different subscales: physical (score from 0 to 10 on the Numeric Pain Rating Scale functioning, role physical, bodily pain, general health, [NPRS]) was collected at baseline to describe the vitality, social function, role emotional and mental Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 4 of 11 health. The score ranges from 0 to 100, with a higher Other outcome measures score indicating better health. Further, the disease-specific Fear of falling was measured by the validated Norwegian Quality of Life Questionnaire of the European Foundation version of the FES-I [39], which measures fear of falling for Osteoporosis (QUALEFFO-41) [6] was also applied, in 16 daily activities. QUALEFFO-41 has five subscales and a total score: pain, physical function, social function, general health percep- Sample size tion, mental function and total score. The score ranges Sample size was calculated based on a substantial mean- from 0 to 100, with a higher score indicating better ingful change of 0.1 m/s in 10-m habitual walking speed, HRQoL. with an expected SD of 0.2 m/s [40] as described in the Fig. 1 Flow of the participants throughout the study period Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 5 of 11 Table 1 Descriptive statistics of the sample at baseline, 3 months and 6 months Total (N = Intervention’ Control Intervention 3 Control 3 Intervention 6 Control 6 149) (N = 76) (N = 73) months months months months Characteristics Age, years, mean (SD) 74.2 (5.8) 74.7 (6.1) 73.7 (5.6) BMI, kg/m , mean (SD) 23.2 (3.7) 23.2 (3.4) 23.2(4.1) Smoking (Yes/No %) 10.7/89.3 14.5/81.5 6.8/93.2 Education, mean (SD) 13.1 (3.4) 12.8 (3.2) 13.5 (3.6) Walking aids (Yes/No %) 19.5/80.5 18.4/81.6 20.5/79.5 Living alone (Yes/No %) 45.1/54.9 47.3/52.7 42.9/57.1 Comorbidity (Yes/No %) 40.5/59.5 38.7/61.3 42.5/57.5 Painkillers (Yes/No %) 41.8/58.2 40.0/60.0 43.7/56.3 Painkillers on prescription (Yes/ 58.6/41.4 53.3/46.7 64.3/35.7 No %) Fear of falling (Yes/No %) 74.0/26.0 75.3/24.7 72.6/27.4 Falls last year (Yes/No %) 43.9/56.1 44.7/55.3 43.1/56.9 IPAQ, % high 32.1 29.3 35.0 % moderate 37.0 46.3 27.5 % low 24.4 37.5 30.9 IPAQ, walking MET, median 743 792 693 693 1039 809 990 225% percentile 264 297 236 264 297 380 371 50% percentile 743 792 693 693 1039 809 990 75% percentile 1386 1386 1386 1485 1518 2079 1733 IPAQ Sitting per day, minutes, 320 (141) 320 (149) 320 (133) 307 (131) 323 (134) 300 (129) 340 (137) mean (SD) NPRS pain, mean (SD) 3.4 (2.5) 3.2 (2.2) 3.5 (2.7) 3.0 (2.1) 3.5 (2.8) 3.1 (2.2) 3.3 (2.9) FES-1, mean (SD) 24.3 (6.7) 24.7 (6.6) 23.8 (6.8) 23.0 (5.2) 23.2 (6.7) 23.8 (6.0) 23.5 (7.6) Physical function, mean (SD) 10 m Walking speed, m/s 1.21 (0.30) 1.20 (0.29) 1.22 (0.30) 1.33 (0.26) 1.30 (0.30) 1.32 (0.28) 1.31 (0.30) FR, cm 34.1 (6.4) 33.9 (6.2) 34.3 (6.6) 34.7 (6.6) 35.6 (8.0) 36.3 (6.4) 35.5 (8.1) FSST, sec 9.61 (3.1) 9.80 (3.2) 9.40 (3.05) 8.93 (2.26) 9.42 (3.29) 8.77 (1.78) 9.13 (3.19) Grip strength, right, kg 22.0 (5.1) 21.6 (4.7) 22.3 (5.4) 21.2 (4.9) 21.6 (4.5 21.1 (5.1) 21.2 (4.6) Arm curls 15.2 (3.8) 15.1 (3.9) 15.3 (3.8) 18.2 (3.5) 17.2 (3.3) 17.8 (3.4) 16.5 (4.0) 30STS 12.6 (3.9) 12.8 (3.6) 12.5 (4.2) 14.6 (4.0) 13.0 (3.7) 14.4 (3.8) 13.3 (4.2) 2.45 m Up and Go, sec 6.51 (2.57) 6.50 (1.97) 6.52 (3.10) 6.46 (1.66) 6.82 (2.35) 6.40 (1.51) 6.75 (2.61) 6 MWD, m 471 (131) 468 (120) 473 (142) 506 (104.8) 490 (133.6) 497.6 (112.8) 506.2 (135.8) Health related quality of life SF-36 scores, mean (SD) Physical functioning 67.6 (22.9) 66.5 (21.0) 68.7 (24.9) 70.4 (19.7) 70.2 (25.2) 69.4 (20.2) 70.7 (25.5) Role physical 63.0 (29.0) 60.6 (27.8) 65.6 (30.1) 67.0 (28.2) 67.2 (31.1) 65.2 (25.9) 67.3 (28.4) Body pain 58.8 (23.7) 57.6 (22.7) 60.0 (24.9) 62.9 (23.6) 64.8 (25.2) 59.2 (23.0) 60.6 (28.2) General health 63.7 (23.3) 63.9 (22.3) 63.4 (24.4) 63.7 (20.3) 64.9 (23.0) 64.0 (20.2) 64.6 (24.7) Vitality 53.9 (16.6) 53.2 (14.7) 54.5 (18.5) 54.3 (17.4) 57.0 (18.5) 54.1 (14.4) 53.7 (18.3) Social function 84.1 (20.5) 85.2 (19.3) 82.9 (21.8) 86.0 (19.6) 84.9 (23.0) 83.7 (20.4) 85.2 (23.3) Role emotional 63.1 (20.6) 63.7 (20.3) 62.6 (20.9) 67.2 (13.9) 65.4 (18.5) 67.9 (16.4) 65.3 (20.2) Mental health 71.6 (13.1) 72.6 (10.4) 70.6 (15.5) 73.8 (9.6) 71.7 (13.9) 70.9 (11.7) 69.7 (14.8) Physical component score 43.0 (10.0) 42.3 (9.2) 43.7 (10.8) 44.0 (9.3) 45.3 (10.6) 43.5 (9.5) 44.5 (11.4) Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 6 of 11 Table 1 Descriptive statistics of the sample at baseline, 3 months and 6 months (Continued) Total (N = Intervention’ Control Intervention 3 Control 3 Intervention 6 Control 6 149) (N = 76) (N = 73) months months months months Mental component score 49.7 (6.6) 50.4 (5.5) 48.9 (7.5) 50.5 (5.3) 49.6 (6.7) 49.8 (5.6) 49.0 (6.6) QUALEFFO-41, mean (SD) Pain 35.3 (25.2) 34.7 (25.0) 35.8 (25.4) 29.3 (25.9) 28.9 (24.8) 33.4 (24.0) 33.7 (26.5) Physical function 17.2 (13.2) 17.3 (10.9) 17.2 (15.3) 14.9 (9.7) 15.5 (13.9) 16.4 (11.3) 16.7 (16.5) Social Function 25.8 (21.1) 28.2 (20.4) 23.4 (21.7) 24.1 (17.7) 20.6 (19.1) 27.9 (21.1) 23.3 (21.7) General Health Perceptions 44.8 (22.5) 46.6 (22.0) 42.9 (23.1) 44.0 (18.9) 44.5 (26.9) 45.2 (21.6) 42.2 (25.9) Mental Function 34.3 (12.9) 34.0 (11.9) 34.5 (14.0) 32.9 (10.8) 33.7 (14.1) 34.3 (11.3) 35.4 (16.5) Total score QUALEFFO 26.7 (13.1) 27.1 (11.1) 26.3 (15.0) 24.4 (10.5) 24.4 (6.7) 26.4 (11.8) 26.0 (16.6) n Number of individuals, SD Standard deviation, NPRS Numeric Pain Rating Scale, IPAQ International Physical Activity Questionnaire (Short Form), MET Metabolic equivalent of task, FES-I Falls Efficacy Scale International, FR Functional reach, FSST Four Square Step Test, 30STS 30-s sit to stand, 6MWD 6-min walking distance, SF-36 36-item Short Form Health Survey. Comorbidity = four or more self-reported diseases There was no statistically significant difference between the intervention group and the control group on any of the descriptive variables or outcome variables at baseline main outcome paper [24]. To obtain 80% statistical fear of falling, and 43.9% had experienced a fall within power with a 5% significance level, 128 participants (64 the last year. At 6 months (3 months post-intervention), per group) were required. the median walking metabolic equivalent of task (MET) measured by IPAQ-SF was 809 for the intervention Statistical analyses group and 990 for the control group (Table 1). Time All analyses were conducted using SPSS 25.0 (SPSS Cor- spent sitting per day was 300 min for the intervention poration, Armonk, NY, USA) and Stata version 15 (Sta- group and 340 min for the control group. For the inter- taCorp LLC, College Station, TX, USA). The data were vention group, the overall adherence to the exercise analysed according to the intention-to-treat (ITT) programme in the original study [24] was 82.6%. No ser- principle for participants who completed the assess- ious adverse events related to the intervention were re- ments. Differences between groups were assessed using ported, but one participant withdrew from the linear mixed models for repeated measurements using a intervention before 12 weeks due to sciatic pain (at 3 subject-specific random intercept and maximum likeli- weeks), and another participant withdrew due to a flare- hood estimation with the respective outcome measure- up of rheumatic disease (at 2 weeks). More details on ad- ment at baseline. Group, time (i.e., post-intervention and verse events not related to the intervention are reported 3-month follow-up) and the interaction between group elsewhere [24]. and time were fixed effects. Mixed models are consid- ered a robust method for missing data in ITT analysis of pre–post studies [41]. The underlying structure of the Repeated measurements model estimates the outcome at each visit, assuming that There was no statistically significant difference between the missing data have the same correlation structure as the intervention and the control group at the 3-month observed data [42]. P-values ≤0.05 were considered sta- follow-up for the primary outcome (Table 2)ofhabitual tistically significant, and all tests were two sided. walking speed (0.03 m/s, 95%CI − 0.02 to 0.08, p =0.271). However, for the secondary outcome of physical fitness, Results there were statistically significant differences in favour of Participants the intervention group for balance using FSST (− 0.68 s, In total 149 participants were recruited to the original 95%CI − 1.24 to − 0.11, p = 0.019), arm curl (1.3, 95%CI study [24], with 76 allocated to the intervention group 0.25 to 2.29, p = 0.015), leg strength using 30STS (1.56, and 73 to the control group. Eight participants in the 95%CI 0.68 to 2.44, p = 0.001) and mobility using 2.45-m intervention group and 11 in the control group were lost up and go (− 0.38 s, 95%CI − 0.74 to − 0.02, p =0.039). at the first (3-month) follow-up. At the second follow- There was also a statistically significant difference between up, eight participants in the intervention group and 13 the groups regarding fear of falling in favour of the inter- in the control group were lost. Further detail on the flow vention group (− 1.7, 95%CI − 2.97 to − 0.38, p =0.011). of the participants is shown in Fig. 1. Regarding the HRQoL instruments, there were no statisti- At baseline, the mean age of the participants was 74.2 cally significant difference between the groups across all years, and the mean for education was 13.1 years at the subscales for either the generic or the disease-specific school. 74% of the included women answered “yes” to instrument (Fig. 2). Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 7 of 11 Table 2 Differences between groups at 3 months post-intervention, adjusted for baseline values. Mean difference refers to intervention-control Outcomes Mean difference 95%CI P value Habitual walking speed 0.03 −0.02 to 0.08 0.271 FR 1.54 −0.68 to 3.77 0.173 FSST −0.68 −1.24 to − 0.11 0.019 Grip strength right 0.07 −0.99 to 1.13 0.895 Arm curl 1.27 0.25 to 2.29 0.015 30STS 1.56 0.68 to 2.44 0.001 2.45-m up and go −0.38 −0.74 to − 0.02 0.039 6MWD −1.06 −19.66 to 17.54 0.911 HRQoL SF-36 Physical functioning 1.73 −3.21 to 6.66 0.490 Role physical 2.69 −3.71 to 9.10 0.408 Bodily pain 0.88 −3.88 to 5.64 0.717 General health −0.00 −4.73 to 4.73 0.999 Vitality 1.84 −2.05 to 5.73 0.353 Social functioning −0.86 −5.76 to 4.05 0.732 Role emotional 1.90 −3.10 to 6.91 0.042 Mental health 0.01 −3.43 to 3.44 0.997 Physical component score 0.82 −2.64 to 1.00 0.374 Mental component score −0.06 −1.78 to 1.66 0.944 QUALEFFO-41 Pain 0.66 −6.06 to 4.74 0.810 Physical function −1.12 −1.56 to 3.80 0.409 Social function −0.39 −5.17 to 4.38 0.871 General health perceptions 0.32 −5.08 to 5.65 0.906 Mental function −1.42 −4.26 to 1.41 0.323 Total QUALEFFO-41 score 0.96 −3.36 to 1.44 0.431 NPRS 0.11 −0.46 to 0.68 0.709 FES-I −1.68 −2.97 to −0.38 0.011 FR Functional reach, FSST Four Square Step Test, 30STS 30-s sit to stand, 6MWD 6-min walking distance, HRQoL Health-related quality of life, SF-36 36-item Short Form Health Survey, QUALEFFO-41 Quality of Life Questionnaire of the European Foundation for Osteoporosis, NPRS Numeric Pain Rating Scale, FES-I Falls Efficacy Scale International. Mean difference refers to intervention minus control Discussion In contrast to our hypothesis, the exercise intervention We have established that in older women with osteo- did not have an effect on the primary outcome – habit- porosis and vertebral fracture, the effects of a 3- ual walking speed – either at the end of the intervention month exercise programme on upper and lower limb [24] or at the 3-month follow-up. Walking speed is con- muscle strength, balance, mobility and fear of falling sidered a robust tool for measuring physical capacity, are maintained, at least in part, at 3 months post- and has extensive predictive capabilities, e.g. on out- intervention. However, there were no between-group comes like functional dependence, mobility and falls differences evident in habitual walking speed or [29]. At baseline, the participants in the present study had HRQoL. Results from the present study are consistent an average habitual walking speed of 1.21 m/s. Compared with other works suggesting that exercise may have a to different cut-off values for walking speed among older sustainable effect on balance, mobility [15] and fear people [29], the walking speeds observed in our study cor- of falling [17] in older women with osteoporotic respond to a functional level in which individuals can vertebral fractures. manage their daily tasks well, are independent in self-care Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 8 of 11 Fig. 2 Line plots of some of the physical fitness measures at baseline, 3 months and 6 months for (a) walking speed, (b) 30STS, (c) arm curl, (d) FSST, (e) grip strength and (f) 2.45-m up and go and have ambulation in the community. Therefore, we small (between-group difference of 0.38 s) and likely not may have observed a ceiling effect for habitual walking clinically meaningful [46]. Maintaining physical activity speed [43], and any further increase may have been diffi- and physical function is important for people with osteo- cult to achieve. In contrast, Bergland et al. [15]reported porosis [47] and may prevent a cycle of physical impair- improved maximum walking speed after a 3-month exer- ment after vertebral fracture [1, 8, 48, 49]. cise intervention, which persisted even after cessation of In contrast to previous studies [15, 16, 50], we exercise at the 12-month follow-up in older women with found no effect of exercise on HRQoL (using either osteoporosis and vertebral fracture. Habitual walking the generic or the disease-specific instrument) at the speed, also referred to as normal walking speed, provides 3-month post-intervention follow-up. Evstigneeva information about an individual’s mobility, whereas meas- et al. [50] and Bergland et al. [15] both reported sta- uring maximum walking speed is associated with muscle tistically significant improvements in QUALEFFO-41 power in the lower extremities [44]. Therefore, maximum score in favour of the exercise intervention group walking speed might have been a more sensitive outcome after 12 months of exercise. However, compared to measure, which is supported by our findings showing a other studies in the same population, the participants significant increase in lower limb and upper limb muscle in our study had higher scores for both the generic strength in the short term. SF-36 and the disease-specific QUALEFFO-41 [8, 15, The improved muscle strength among the participants 50]; thus, we may have experienced ceiling effects. in the intervention group at the 3-month post- Several studies show that osteoporosis has a negative intervention follow-up is interesting, as we know that effect on HRQoL [7], and within the population with muscle strength naturally declines with age [20]. Our osteoporosis, people with vertebral fracture report findings are in line with those of a recent randomised moderately lower physical health status compared to controlled trial of home exercises in older women with osteoporotic people without vertebral fracture [7]. vertebral fracture, which reported improved functional Therefore, there is merit in identifying how to im- leg muscle strength after 12 months [18]. Maintenance prove HRQoL among those with osteoporosis and low of muscle strength may prevent loss of functional de- self-reported HRQoL. pendence [27]. A systematic review reported that exer- cise may prevent falls and fall-related fractures and Strengths and limitations reduce risk factors for falls in individuals with low bone One of the strengths of our study was its design as a mineral density [45]. However, individuals with vertebral single-blinded randomised controlled trial. We published fractures may have pain or hyperkyphosis that modifies a study protocol a priori which elaborated on the back- the effect of exercise on fall or fracture risk. The effect ground, rationale for the study, assessment of outcomes of exercise on mobility as measured by the 2.45-m up and how the intervention would be carried out [25]. An and go is promising, but the magnitude of the effect was available study protocol can reduce publication bias and Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 9 of 11 improve reproducibility [26]. Furthermore, the interven- Acknowledgements We are incredibly thankful to the participants for their participation. We also tion applied was informed by exercise recommendations want to thank the dedicated physiotherapists who contributed to the for people with osteoporosis or osteoporotic vertebral intervention and assessment of the participants this study. fractures [13] and described according to the Consensus on Exercise Reporting Template (CERT -statement [51]. Authors’ contributions BS was involved in designing the exercise programme as well as outcome Some limitations of the study should be mentioned. measures and administered the intervention programme. AB was responsible Information about exercise habits or frequency in the for the internal grant application for this trial. BS, AB and HB contributed to intervention and control groups could have been ex- the design of the study. BS analysed the data in collaboration with AHP. BS was the primary researcher responsible for drafting the initial manuscript and plored in more detail. The follow-up time of the present revising it critically for important intellectual content. HB, LG, DAS and AHP study was short, which restricts our ability to make in- contributed to drafting the manuscript and revising it critically for important ferences regarding maintenance effects of exercise be- intellectual content. AHP contributed to the statistical plan and analyses for this study. All authors read, critically revised, and approved the final version yond 3 months post-intervention. Number, location and of this manuscript. severity of vertebral fractures are associated with pain, disability and HRQoL [8, 52] and could add valuable in- Funding formation for interpretation and generalisability of the The project received internal funding from Oslo Metropolitan University. The funding body had no role in the design of the study, in writing the results. Unfortunately, this information was not available manuscript or in the collection, analysis or interpretation of the data. The to us, neither was information regarding the participants study received no external funding. anti-osteoporotic drug prescriptions. Finally, our sample was a relatively healthy group of Availability of data and materials The datasets generated and/or analysed during the study are only available individuals with vertebral fractures living at home. Our to the participating researchers due to data protection laws. Subsets or findings may not be generalisable in individuals living in aggregation of these data will not include information that could assisted settings, individuals who are more frail or indi- compromise research participants’ privacy. Consent can be made available from the corresponding author on reasonable request. viduals who have cognitive impairment, as the curve of decline in physical function may be steeper and affected Ethics approval and consent to participate by age and number of vertebral fractures [21]. Physical The project proposal was approved by the Regional Committee for Ethics in and cognitive impairments may have made it difficult to Medical Research (South-East Norway) with the registration number 2014/ 2050. Written informed consent was obtained from all participants included participate or adhere to the intervention. in the analyses, and the project was conducted according to the World Medical Association Declaration of Helsinki. Conclusions Consent for publication In conclusion, the positive effects of a resistance and bal- Not applicable. ance exercise programme on physical fitness (e.g., muscle strength, balance and mobility) and fear of falling Competing interests LG received funding from Osteoporosis Canada related to exercise guideline persisted to some extent 3 months after cessation of ex- development, which occurred after the initiation of this clinical trial. She also ercise in older women with osteoporosis and vertebral received funding or in-kind support from Osteoporosis Canada related to the fracture. There was no effect on walking speed or development of knowledge translation tools freely available to patients. DAS is a Director of Later Life Training, a not-for-profit company that delivers HRQoL at follow-up. training to health and fitness professionals who work with older people, in- cluding those with osteoporosis. All other authors declare no conflict of interest. Supplementary information Supplementary information accompanies this paper at https://doi.org/10. Author details 1186/s12891-020-03495-9. Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway. Department of Kinesiology, University of Waterloo and Schlegel-UW Research Institute for Aging, Waterloo, Canada. School of Additional file 1. CONSORT 2010 checklist of information to include Health and Life Sciences, Institute of Applied Health Research, Centre for when reporting a randomised trial. Living, Glasgow Caledonian University, Glasgow, UK. Additional file 2. Detailed description of the intervention following the CERT-guidelines. Received: 1 April 2020 Accepted: 8 July 2020 Abbreviations References 30STS: 30-s sit to stand; 6MWT: 6-min walk test; DXA: Dual-energy x-ray ab- 1. Cauley JA. Public health impact of osteoporosis. J Gerontol A Biol Sci Med sorptiometry technology; FES-I: Falls Efficacy Scale International; Sci. 2013;68(10):1243–51. FR: Functional reach; FSST: Four Square Step Test; HRQoL: Health-related 2. Svedbom A, Hernlund E, Ivergard M, Compston J, Cooper C, Stenmark J, quality of life; IPAQ-SF: International Physical Activity Questionnaire Short McCloskey EV, Jonsson B, Kanis JA. 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Physical fitness in older women with osteoporosis and vertebral fracture after a resistance and balance exercise programme: 3-month post-intervention follow-up of a randomised controlled trial

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Abstract

Background: Exercise is recommended for individuals with vertebral fractures, but few studies have investigated the effect of exercise on outcomes of importance for this population. Post-intervention effects of exercise are even less studied. The objective of this study was to evaluate habitual walking speed and other health-related outcomes after cessation of a 3-month exercise intervention. Methods: This follow-up study was conducted 3 months post-intervention of a randomised controlled trial. A total of 149 community-dwelling Norwegian women aged 65 years or older, diagnosed with osteoporosis and vertebral fracture were randomised into either exercise or control group. Primary outcome was habitual walking speed at 3 months. Secondary outcomes were other measures of physical fitness – including the Four Square Step Test (FSST), functional reach, grip strength and Senior Fitness Test – measures of health-related quality of life and fear of falling. Herein we report secondary data analysis of all outcomes at 6 months (3 months post-intervention). Data were analysed according to the intention-to- treat principle, linear mixed regression models were employed. Results: For the primary outcome, habitual walking speed, there was no statistically significant difference between groups (0.03 m/s, 95%CI − 0.02 to 0.08, p = 0.271) at the 3-month post-intervention follow-up. For secondary outcomes of physical fitness, statistically significant differences in favour of the intervention group were found for balance using the FSST (− 0.68 s, 95%CI − 1.24 to − 0.11, p = 0.019), arm curl (1.3, 95%CI 0.25 to 2.29, p = 0.015), leg strength using the 30-s sit to stand (1.56, 95%CI 0.68 to 2.44, p = 0.001) and mobility using the 2.45-m up and go (− 0.38 s, 95%CI − 0.74 to − 0.02, p =0.039). There was a statistically significant difference between the groups regarding fear of falling in favour of the intervention group (− 1.7, 95%CI − 2.97 to − 0.38, p = 0.011). No differences between groups were observed for health-related quality of life. Conclusion: The results show the improved effects of a multicomponent exercise programme on outcomes like muscle strength, balance and mobility as well as fear of falling in a group of older women with osteoporosis and vertebral fracture 3 months post-intervention. Trial registration: ClinicalTrials.gov Identifier: NCT02781974. Registered 25.05.16. Retrospectively registered. Keywords: Osteoporosis, Vertebral fracture, Exercise, Physical fitness, Short-term effects * Correspondence: bsugland@oslomet.no Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 2 of 11 Background older women with osteoporosis and vertebral fracture. Vertebral fractures are among the most common fragility However, there was no effect immediately post- fractures caused by osteoporosis [1, 2]. In the European intervention on habitual walking speed and HRQoL. It is Union in 2010, there were 3.5 million new fragility frac- important to evaluate whether effects of exercise on tures, and 520,000 of them were vertebral fractures [2]. muscle strength, balance and fear of falling would be sus- These numbers are likely an underestimate, as only about tained upon cessation of the intervention and whether two-thirds of vertebral fractures come to clinical attention there would be changes in habitual walking speed or QoL [3]. The risk of new vertebral fractures increases with the at follow-up. Thus, the aim of the current study was to number and severity of prevalent vertebral fractures [3]. examine the changes to habitual walking speed and other Vertebral fractures are associated with increased mortality health-related outcomes after cessation of a 3-month and morbidity [3, 4] and contribute to back pain, impaired exercise intervention compared to a control group. physical function and lower health-related quality of life (HRQoL) [5–8]. Methods Clinical practice guidelines for the management of We conducted a single-blinded randomised controlled osteoporosis emphasise the importance of exercise [9, 10]. trial with two arms, with participants allocated to the con- There is evidence that exercise prevents falls in older trol or intervention group in a 1:1 ratio. A computer- people [11]. Exercise can improve physical function, activ- generated permuted block randomisation scheme pro- ities of daily living and HRQoL in older people who are vided by a statistician was used to allocate the participants. frail [12]. However, individuals with vertebral fractures re- The scheme was kept and administered by a person not quire exercise that is tailored to address safety and related involved with the study participants and was unavailable impairments [13]. A recently updated systematic review to others. The block sizes varied from four to eight. on the effect of exercise for people with vertebral fracture The intervention group attended a resistance and balance [14] concluded that there is moderate-quality evidence exercise programme twice weekly for 12 weeks. The control that exercise improves physical performance. However, group was asked to live life as usual [24, 25]. In the period few studies have evaluated whether the effects of exercise from the end of intervention to the 3-month follow-up, all are sustained after the intervention has ceased [15–18]. participants were instructed to live life as usual. That meant The results from a limited number of studies examining continuing with their usual activities and maintaining their follow-up after cessation of exercise in older women with usual level of physical activity. The present study reports on osteoporosis and vertebral fracture were promising. In follow-up measurements performed 3 months after com- these individual studies (ranging from 12 weeks to 12 pleting the intervention or control activities (6 months months of follow-up), the sustained effects of exercise post-randomisation). Detailed information on the study were reported on QoL [16]; maximum walking speed, protocol is reported elsewhere [25]. Reporting follows the mobility and HRQoL [15]; functional leg muscle strength CONSORT 2010 statement [26], and a CONSORT check- [18]; and fear of falling [17]. list is provided in the Supplementary Files.The studywas Understanding whether the effects of an exercise inter- approved by the Regional Committee for Medical Research vention persist after cessation is important for several Ethics in South East Norway (Ref. 2014/2050) and is reasons. Sustaining adherence to exercise and thus any registered with Clinical Trials (NCT02781974). benefits from supervised resistance training is difficult without the support and help of staff [19]. The natural Settings and participants decline in physical fitness caused by aging may counter- The study was conducted both at facilities at Oslo act the gains from an exercise intervention if it is not Metropolitan University in Oslo, Norway and at a maintained. Muscle strength gained after an intervention physiotherapy clinic near Oslo. Recruitment of partici- is often lost or decreased in older people after a period pants was done from outpatient clinics for osteoporosis of detraining [20]. Similarly, improvements in balance in at two different public hospitals and a private speciality older adults may also be lost after detraining [21–23]. outpatient clinic in or nearby Oslo. The recruitment Conversely, it is possible that participating in an exercise period was from January 2016 to April 2018, with the intervention may motivate some participants to maintain last follow-up test completed in October 2018. The exercise outside of the trial to preserve the benefits or recruitment ended once the desired number of partici- see continued improvements. pants was reached. All patients provided written We have previously reported on a randomised con- informed consent prior to baseline testing. trolled trial [24] of a multicomponent exercise programme The inclusion criteria were female sex, age 65 years or informed by exercise recommendations for people with older, community dwelling and a diagnosis of osteoporosis osteoporotic vertebral fracture [13]. In that study, exercise defined as a T score ≤− 2.5 SD at the femoral neck or improved muscle strength, balance and fear of falling in lumbar spine verified by dual X-ray absorptiometry Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 3 of 11 (DXA). To be included, the participants had to have at population. Information about walking and time spent least one prevalent vertebral fracture classified as grade 1, sitting (measured by the International Physical Activity 2 or 3 by the Genant method [3] or verified by DXA- Questionnaire Short Form [IPAQ-SF]), afraid of falling based vertebral fracture assessment or via X-ray by med- (yes/no) and pain level in the previous week (measured ical doctors not involved in the study. Further, participants by NPRS) was collected at the intervention end and at had to be able to walk independently with or without a the 3-month follow-up. walking aid and able to speak and understand Norwegian. Exclusion of potential participants were done if they had Primary outcome known medical contraindications for exercising, such as The primary outcome of the original trial was physical severe lung diseases or progressive neurological disorders. fitness measured by 10-m habitual walking speed. Partic- ipants were instructed to walk 10-m from a static start Intervention at a comfortable pace (self-selected speed) [29]. This was The intervention was a group-based resistance and bal- repeated three times, and the average speed in metres ance circuit programme instructed by an experienced per second was calculated. physiotherapist. The design of the programme was in- formed by recommendations for exercising for people Secondary outcomes with osteoporosis and vertebral fracture [13] and from ex- Secondary outcomes were measures of physical fitness ercise recommendations for older people [27]. The inter- (balance, muscle strength and endurance), HRQoL and vention focused on weight-bearing exercises to improve the Falls Efficacy Scale International (FES-I). muscle strength and balance as well as strengthening exer- cises for the back extensors and upper arm muscles. Physical fitness Each exercise session lasted 1 h and consisted of two The Four Square Step Test (FSST) [30] and func- rounds of eight different strength and balance exercises tional reach (FR) [31] were used to assess balance. performed in a circuit, with a short warm-up before the FSST is a dynamic balance test [30]and is shownto circuit and closing with flexibility and stretching. The be valid and reliable when used to test community- group had up to eight participants, and safety consider- dwelling elderly adults. A cut-off score of 15 s dis- ations were a priority both when designing the programme criminates between multiple fallers (over 15 s) and and during each session. The experienced physiotherapist non-multiple fallers, with a sensitivity of 85% and a was responsible for adjustments and progression of the ex- specificity of 88–100% [30]. FR is a reliable and valid ercises for each participant throughout the exercise period. measure of balance [31] that measures the capacity The exercise goal was moderate intensity, corresponding to reach forward in an anticipatory postural adjust- to 8–12 repetitions for each exercise and a perceived level ment task [32]. Grip strength was measured with a of exertion of 13 to 14 on the Borg Rating of Perceived Ex- hydraulic handheld dynamometer [33]. Handgrip ertion scale [28]. The intervention is described in more de- strength is a simple and reliable test for the assess- tail elsewhere [24, 25] and in Supplementary File 2. ment of muscle status in older adults [33–35]. Indi- The participants allocated to the control group were vidual tests from the validated Senior Fitness Test instructed to live life as usual, which meant continuing were also applied: lower extremity leg strength (30-s with their usual everyday life and level of physical activ- sit to stand [30STS]), mobility (2.45-m up and go), ity during the study period. Participants in the control upper arm strength (number of arm curls in 30 s group were offered to take part in the exercise with a 2.3-kg [5-lb] weight) and functional endur- programme after their last follow-up assessment at 6 ance (6-min walk test [6MWT]). The Senior Fitness months post-randomisation. Test is a valid and reliable test for physical fitness in older people and consists of several tests that assess Outcome measures underlying physical components associated with Trained physiotherapists, blinded to group allocation, mobility [36]. assessed the outcome measures at baseline, at the inter- vention end (3 months) and at the 3-month follow-up HRQoL (6 months). Background information such as age, edu- The 36-item Short Form Health Survey (SF-36) [37] cation, body mass index, smoking status, medication, is a generic instrument for measuring HRQoL, found comorbidities, living alone or not, afraid of falling or to be valid and reliable in the general older popula- not, injuries caused by falls, taking analgesics (yes/no), tion [38]. It is divided into physical and mental com- physical activity and pain level in the previous week ponents based on eight different subscales: physical (score from 0 to 10 on the Numeric Pain Rating Scale functioning, role physical, bodily pain, general health, [NPRS]) was collected at baseline to describe the vitality, social function, role emotional and mental Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 4 of 11 health. The score ranges from 0 to 100, with a higher Other outcome measures score indicating better health. Further, the disease-specific Fear of falling was measured by the validated Norwegian Quality of Life Questionnaire of the European Foundation version of the FES-I [39], which measures fear of falling for Osteoporosis (QUALEFFO-41) [6] was also applied, in 16 daily activities. QUALEFFO-41 has five subscales and a total score: pain, physical function, social function, general health percep- Sample size tion, mental function and total score. The score ranges Sample size was calculated based on a substantial mean- from 0 to 100, with a higher score indicating better ingful change of 0.1 m/s in 10-m habitual walking speed, HRQoL. with an expected SD of 0.2 m/s [40] as described in the Fig. 1 Flow of the participants throughout the study period Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 5 of 11 Table 1 Descriptive statistics of the sample at baseline, 3 months and 6 months Total (N = Intervention’ Control Intervention 3 Control 3 Intervention 6 Control 6 149) (N = 76) (N = 73) months months months months Characteristics Age, years, mean (SD) 74.2 (5.8) 74.7 (6.1) 73.7 (5.6) BMI, kg/m , mean (SD) 23.2 (3.7) 23.2 (3.4) 23.2(4.1) Smoking (Yes/No %) 10.7/89.3 14.5/81.5 6.8/93.2 Education, mean (SD) 13.1 (3.4) 12.8 (3.2) 13.5 (3.6) Walking aids (Yes/No %) 19.5/80.5 18.4/81.6 20.5/79.5 Living alone (Yes/No %) 45.1/54.9 47.3/52.7 42.9/57.1 Comorbidity (Yes/No %) 40.5/59.5 38.7/61.3 42.5/57.5 Painkillers (Yes/No %) 41.8/58.2 40.0/60.0 43.7/56.3 Painkillers on prescription (Yes/ 58.6/41.4 53.3/46.7 64.3/35.7 No %) Fear of falling (Yes/No %) 74.0/26.0 75.3/24.7 72.6/27.4 Falls last year (Yes/No %) 43.9/56.1 44.7/55.3 43.1/56.9 IPAQ, % high 32.1 29.3 35.0 % moderate 37.0 46.3 27.5 % low 24.4 37.5 30.9 IPAQ, walking MET, median 743 792 693 693 1039 809 990 225% percentile 264 297 236 264 297 380 371 50% percentile 743 792 693 693 1039 809 990 75% percentile 1386 1386 1386 1485 1518 2079 1733 IPAQ Sitting per day, minutes, 320 (141) 320 (149) 320 (133) 307 (131) 323 (134) 300 (129) 340 (137) mean (SD) NPRS pain, mean (SD) 3.4 (2.5) 3.2 (2.2) 3.5 (2.7) 3.0 (2.1) 3.5 (2.8) 3.1 (2.2) 3.3 (2.9) FES-1, mean (SD) 24.3 (6.7) 24.7 (6.6) 23.8 (6.8) 23.0 (5.2) 23.2 (6.7) 23.8 (6.0) 23.5 (7.6) Physical function, mean (SD) 10 m Walking speed, m/s 1.21 (0.30) 1.20 (0.29) 1.22 (0.30) 1.33 (0.26) 1.30 (0.30) 1.32 (0.28) 1.31 (0.30) FR, cm 34.1 (6.4) 33.9 (6.2) 34.3 (6.6) 34.7 (6.6) 35.6 (8.0) 36.3 (6.4) 35.5 (8.1) FSST, sec 9.61 (3.1) 9.80 (3.2) 9.40 (3.05) 8.93 (2.26) 9.42 (3.29) 8.77 (1.78) 9.13 (3.19) Grip strength, right, kg 22.0 (5.1) 21.6 (4.7) 22.3 (5.4) 21.2 (4.9) 21.6 (4.5 21.1 (5.1) 21.2 (4.6) Arm curls 15.2 (3.8) 15.1 (3.9) 15.3 (3.8) 18.2 (3.5) 17.2 (3.3) 17.8 (3.4) 16.5 (4.0) 30STS 12.6 (3.9) 12.8 (3.6) 12.5 (4.2) 14.6 (4.0) 13.0 (3.7) 14.4 (3.8) 13.3 (4.2) 2.45 m Up and Go, sec 6.51 (2.57) 6.50 (1.97) 6.52 (3.10) 6.46 (1.66) 6.82 (2.35) 6.40 (1.51) 6.75 (2.61) 6 MWD, m 471 (131) 468 (120) 473 (142) 506 (104.8) 490 (133.6) 497.6 (112.8) 506.2 (135.8) Health related quality of life SF-36 scores, mean (SD) Physical functioning 67.6 (22.9) 66.5 (21.0) 68.7 (24.9) 70.4 (19.7) 70.2 (25.2) 69.4 (20.2) 70.7 (25.5) Role physical 63.0 (29.0) 60.6 (27.8) 65.6 (30.1) 67.0 (28.2) 67.2 (31.1) 65.2 (25.9) 67.3 (28.4) Body pain 58.8 (23.7) 57.6 (22.7) 60.0 (24.9) 62.9 (23.6) 64.8 (25.2) 59.2 (23.0) 60.6 (28.2) General health 63.7 (23.3) 63.9 (22.3) 63.4 (24.4) 63.7 (20.3) 64.9 (23.0) 64.0 (20.2) 64.6 (24.7) Vitality 53.9 (16.6) 53.2 (14.7) 54.5 (18.5) 54.3 (17.4) 57.0 (18.5) 54.1 (14.4) 53.7 (18.3) Social function 84.1 (20.5) 85.2 (19.3) 82.9 (21.8) 86.0 (19.6) 84.9 (23.0) 83.7 (20.4) 85.2 (23.3) Role emotional 63.1 (20.6) 63.7 (20.3) 62.6 (20.9) 67.2 (13.9) 65.4 (18.5) 67.9 (16.4) 65.3 (20.2) Mental health 71.6 (13.1) 72.6 (10.4) 70.6 (15.5) 73.8 (9.6) 71.7 (13.9) 70.9 (11.7) 69.7 (14.8) Physical component score 43.0 (10.0) 42.3 (9.2) 43.7 (10.8) 44.0 (9.3) 45.3 (10.6) 43.5 (9.5) 44.5 (11.4) Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 6 of 11 Table 1 Descriptive statistics of the sample at baseline, 3 months and 6 months (Continued) Total (N = Intervention’ Control Intervention 3 Control 3 Intervention 6 Control 6 149) (N = 76) (N = 73) months months months months Mental component score 49.7 (6.6) 50.4 (5.5) 48.9 (7.5) 50.5 (5.3) 49.6 (6.7) 49.8 (5.6) 49.0 (6.6) QUALEFFO-41, mean (SD) Pain 35.3 (25.2) 34.7 (25.0) 35.8 (25.4) 29.3 (25.9) 28.9 (24.8) 33.4 (24.0) 33.7 (26.5) Physical function 17.2 (13.2) 17.3 (10.9) 17.2 (15.3) 14.9 (9.7) 15.5 (13.9) 16.4 (11.3) 16.7 (16.5) Social Function 25.8 (21.1) 28.2 (20.4) 23.4 (21.7) 24.1 (17.7) 20.6 (19.1) 27.9 (21.1) 23.3 (21.7) General Health Perceptions 44.8 (22.5) 46.6 (22.0) 42.9 (23.1) 44.0 (18.9) 44.5 (26.9) 45.2 (21.6) 42.2 (25.9) Mental Function 34.3 (12.9) 34.0 (11.9) 34.5 (14.0) 32.9 (10.8) 33.7 (14.1) 34.3 (11.3) 35.4 (16.5) Total score QUALEFFO 26.7 (13.1) 27.1 (11.1) 26.3 (15.0) 24.4 (10.5) 24.4 (6.7) 26.4 (11.8) 26.0 (16.6) n Number of individuals, SD Standard deviation, NPRS Numeric Pain Rating Scale, IPAQ International Physical Activity Questionnaire (Short Form), MET Metabolic equivalent of task, FES-I Falls Efficacy Scale International, FR Functional reach, FSST Four Square Step Test, 30STS 30-s sit to stand, 6MWD 6-min walking distance, SF-36 36-item Short Form Health Survey. Comorbidity = four or more self-reported diseases There was no statistically significant difference between the intervention group and the control group on any of the descriptive variables or outcome variables at baseline main outcome paper [24]. To obtain 80% statistical fear of falling, and 43.9% had experienced a fall within power with a 5% significance level, 128 participants (64 the last year. At 6 months (3 months post-intervention), per group) were required. the median walking metabolic equivalent of task (MET) measured by IPAQ-SF was 809 for the intervention Statistical analyses group and 990 for the control group (Table 1). Time All analyses were conducted using SPSS 25.0 (SPSS Cor- spent sitting per day was 300 min for the intervention poration, Armonk, NY, USA) and Stata version 15 (Sta- group and 340 min for the control group. For the inter- taCorp LLC, College Station, TX, USA). The data were vention group, the overall adherence to the exercise analysed according to the intention-to-treat (ITT) programme in the original study [24] was 82.6%. No ser- principle for participants who completed the assess- ious adverse events related to the intervention were re- ments. Differences between groups were assessed using ported, but one participant withdrew from the linear mixed models for repeated measurements using a intervention before 12 weeks due to sciatic pain (at 3 subject-specific random intercept and maximum likeli- weeks), and another participant withdrew due to a flare- hood estimation with the respective outcome measure- up of rheumatic disease (at 2 weeks). More details on ad- ment at baseline. Group, time (i.e., post-intervention and verse events not related to the intervention are reported 3-month follow-up) and the interaction between group elsewhere [24]. and time were fixed effects. Mixed models are consid- ered a robust method for missing data in ITT analysis of pre–post studies [41]. The underlying structure of the Repeated measurements model estimates the outcome at each visit, assuming that There was no statistically significant difference between the missing data have the same correlation structure as the intervention and the control group at the 3-month observed data [42]. P-values ≤0.05 were considered sta- follow-up for the primary outcome (Table 2)ofhabitual tistically significant, and all tests were two sided. walking speed (0.03 m/s, 95%CI − 0.02 to 0.08, p =0.271). However, for the secondary outcome of physical fitness, Results there were statistically significant differences in favour of Participants the intervention group for balance using FSST (− 0.68 s, In total 149 participants were recruited to the original 95%CI − 1.24 to − 0.11, p = 0.019), arm curl (1.3, 95%CI study [24], with 76 allocated to the intervention group 0.25 to 2.29, p = 0.015), leg strength using 30STS (1.56, and 73 to the control group. Eight participants in the 95%CI 0.68 to 2.44, p = 0.001) and mobility using 2.45-m intervention group and 11 in the control group were lost up and go (− 0.38 s, 95%CI − 0.74 to − 0.02, p =0.039). at the first (3-month) follow-up. At the second follow- There was also a statistically significant difference between up, eight participants in the intervention group and 13 the groups regarding fear of falling in favour of the inter- in the control group were lost. Further detail on the flow vention group (− 1.7, 95%CI − 2.97 to − 0.38, p =0.011). of the participants is shown in Fig. 1. Regarding the HRQoL instruments, there were no statisti- At baseline, the mean age of the participants was 74.2 cally significant difference between the groups across all years, and the mean for education was 13.1 years at the subscales for either the generic or the disease-specific school. 74% of the included women answered “yes” to instrument (Fig. 2). Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 7 of 11 Table 2 Differences between groups at 3 months post-intervention, adjusted for baseline values. Mean difference refers to intervention-control Outcomes Mean difference 95%CI P value Habitual walking speed 0.03 −0.02 to 0.08 0.271 FR 1.54 −0.68 to 3.77 0.173 FSST −0.68 −1.24 to − 0.11 0.019 Grip strength right 0.07 −0.99 to 1.13 0.895 Arm curl 1.27 0.25 to 2.29 0.015 30STS 1.56 0.68 to 2.44 0.001 2.45-m up and go −0.38 −0.74 to − 0.02 0.039 6MWD −1.06 −19.66 to 17.54 0.911 HRQoL SF-36 Physical functioning 1.73 −3.21 to 6.66 0.490 Role physical 2.69 −3.71 to 9.10 0.408 Bodily pain 0.88 −3.88 to 5.64 0.717 General health −0.00 −4.73 to 4.73 0.999 Vitality 1.84 −2.05 to 5.73 0.353 Social functioning −0.86 −5.76 to 4.05 0.732 Role emotional 1.90 −3.10 to 6.91 0.042 Mental health 0.01 −3.43 to 3.44 0.997 Physical component score 0.82 −2.64 to 1.00 0.374 Mental component score −0.06 −1.78 to 1.66 0.944 QUALEFFO-41 Pain 0.66 −6.06 to 4.74 0.810 Physical function −1.12 −1.56 to 3.80 0.409 Social function −0.39 −5.17 to 4.38 0.871 General health perceptions 0.32 −5.08 to 5.65 0.906 Mental function −1.42 −4.26 to 1.41 0.323 Total QUALEFFO-41 score 0.96 −3.36 to 1.44 0.431 NPRS 0.11 −0.46 to 0.68 0.709 FES-I −1.68 −2.97 to −0.38 0.011 FR Functional reach, FSST Four Square Step Test, 30STS 30-s sit to stand, 6MWD 6-min walking distance, HRQoL Health-related quality of life, SF-36 36-item Short Form Health Survey, QUALEFFO-41 Quality of Life Questionnaire of the European Foundation for Osteoporosis, NPRS Numeric Pain Rating Scale, FES-I Falls Efficacy Scale International. Mean difference refers to intervention minus control Discussion In contrast to our hypothesis, the exercise intervention We have established that in older women with osteo- did not have an effect on the primary outcome – habit- porosis and vertebral fracture, the effects of a 3- ual walking speed – either at the end of the intervention month exercise programme on upper and lower limb [24] or at the 3-month follow-up. Walking speed is con- muscle strength, balance, mobility and fear of falling sidered a robust tool for measuring physical capacity, are maintained, at least in part, at 3 months post- and has extensive predictive capabilities, e.g. on out- intervention. However, there were no between-group comes like functional dependence, mobility and falls differences evident in habitual walking speed or [29]. At baseline, the participants in the present study had HRQoL. Results from the present study are consistent an average habitual walking speed of 1.21 m/s. Compared with other works suggesting that exercise may have a to different cut-off values for walking speed among older sustainable effect on balance, mobility [15] and fear people [29], the walking speeds observed in our study cor- of falling [17] in older women with osteoporotic respond to a functional level in which individuals can vertebral fractures. manage their daily tasks well, are independent in self-care Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 8 of 11 Fig. 2 Line plots of some of the physical fitness measures at baseline, 3 months and 6 months for (a) walking speed, (b) 30STS, (c) arm curl, (d) FSST, (e) grip strength and (f) 2.45-m up and go and have ambulation in the community. Therefore, we small (between-group difference of 0.38 s) and likely not may have observed a ceiling effect for habitual walking clinically meaningful [46]. Maintaining physical activity speed [43], and any further increase may have been diffi- and physical function is important for people with osteo- cult to achieve. In contrast, Bergland et al. [15]reported porosis [47] and may prevent a cycle of physical impair- improved maximum walking speed after a 3-month exer- ment after vertebral fracture [1, 8, 48, 49]. cise intervention, which persisted even after cessation of In contrast to previous studies [15, 16, 50], we exercise at the 12-month follow-up in older women with found no effect of exercise on HRQoL (using either osteoporosis and vertebral fracture. Habitual walking the generic or the disease-specific instrument) at the speed, also referred to as normal walking speed, provides 3-month post-intervention follow-up. Evstigneeva information about an individual’s mobility, whereas meas- et al. [50] and Bergland et al. [15] both reported sta- uring maximum walking speed is associated with muscle tistically significant improvements in QUALEFFO-41 power in the lower extremities [44]. Therefore, maximum score in favour of the exercise intervention group walking speed might have been a more sensitive outcome after 12 months of exercise. However, compared to measure, which is supported by our findings showing a other studies in the same population, the participants significant increase in lower limb and upper limb muscle in our study had higher scores for both the generic strength in the short term. SF-36 and the disease-specific QUALEFFO-41 [8, 15, The improved muscle strength among the participants 50]; thus, we may have experienced ceiling effects. in the intervention group at the 3-month post- Several studies show that osteoporosis has a negative intervention follow-up is interesting, as we know that effect on HRQoL [7], and within the population with muscle strength naturally declines with age [20]. Our osteoporosis, people with vertebral fracture report findings are in line with those of a recent randomised moderately lower physical health status compared to controlled trial of home exercises in older women with osteoporotic people without vertebral fracture [7]. vertebral fracture, which reported improved functional Therefore, there is merit in identifying how to im- leg muscle strength after 12 months [18]. Maintenance prove HRQoL among those with osteoporosis and low of muscle strength may prevent loss of functional de- self-reported HRQoL. pendence [27]. A systematic review reported that exer- cise may prevent falls and fall-related fractures and Strengths and limitations reduce risk factors for falls in individuals with low bone One of the strengths of our study was its design as a mineral density [45]. However, individuals with vertebral single-blinded randomised controlled trial. We published fractures may have pain or hyperkyphosis that modifies a study protocol a priori which elaborated on the back- the effect of exercise on fall or fracture risk. The effect ground, rationale for the study, assessment of outcomes of exercise on mobility as measured by the 2.45-m up and how the intervention would be carried out [25]. An and go is promising, but the magnitude of the effect was available study protocol can reduce publication bias and Stanghelle et al. BMC Musculoskeletal Disorders (2020) 21:471 Page 9 of 11 improve reproducibility [26]. Furthermore, the interven- Acknowledgements We are incredibly thankful to the participants for their participation. We also tion applied was informed by exercise recommendations want to thank the dedicated physiotherapists who contributed to the for people with osteoporosis or osteoporotic vertebral intervention and assessment of the participants this study. fractures [13] and described according to the Consensus on Exercise Reporting Template (CERT -statement [51]. Authors’ contributions BS was involved in designing the exercise programme as well as outcome Some limitations of the study should be mentioned. measures and administered the intervention programme. AB was responsible Information about exercise habits or frequency in the for the internal grant application for this trial. BS, AB and HB contributed to intervention and control groups could have been ex- the design of the study. BS analysed the data in collaboration with AHP. BS was the primary researcher responsible for drafting the initial manuscript and plored in more detail. The follow-up time of the present revising it critically for important intellectual content. HB, LG, DAS and AHP study was short, which restricts our ability to make in- contributed to drafting the manuscript and revising it critically for important ferences regarding maintenance effects of exercise be- intellectual content. AHP contributed to the statistical plan and analyses for this study. All authors read, critically revised, and approved the final version yond 3 months post-intervention. Number, location and of this manuscript. severity of vertebral fractures are associated with pain, disability and HRQoL [8, 52] and could add valuable in- Funding formation for interpretation and generalisability of the The project received internal funding from Oslo Metropolitan University. The funding body had no role in the design of the study, in writing the results. Unfortunately, this information was not available manuscript or in the collection, analysis or interpretation of the data. The to us, neither was information regarding the participants study received no external funding. anti-osteoporotic drug prescriptions. Finally, our sample was a relatively healthy group of Availability of data and materials The datasets generated and/or analysed during the study are only available individuals with vertebral fractures living at home. Our to the participating researchers due to data protection laws. Subsets or findings may not be generalisable in individuals living in aggregation of these data will not include information that could assisted settings, individuals who are more frail or indi- compromise research participants’ privacy. Consent can be made available from the corresponding author on reasonable request. viduals who have cognitive impairment, as the curve of decline in physical function may be steeper and affected Ethics approval and consent to participate by age and number of vertebral fractures [21]. Physical The project proposal was approved by the Regional Committee for Ethics in and cognitive impairments may have made it difficult to Medical Research (South-East Norway) with the registration number 2014/ 2050. Written informed consent was obtained from all participants included participate or adhere to the intervention. in the analyses, and the project was conducted according to the World Medical Association Declaration of Helsinki. Conclusions Consent for publication In conclusion, the positive effects of a resistance and bal- Not applicable. ance exercise programme on physical fitness (e.g., muscle strength, balance and mobility) and fear of falling Competing interests LG received funding from Osteoporosis Canada related to exercise guideline persisted to some extent 3 months after cessation of ex- development, which occurred after the initiation of this clinical trial. She also ercise in older women with osteoporosis and vertebral received funding or in-kind support from Osteoporosis Canada related to the fracture. There was no effect on walking speed or development of knowledge translation tools freely available to patients. DAS is a Director of Later Life Training, a not-for-profit company that delivers HRQoL at follow-up. training to health and fitness professionals who work with older people, in- cluding those with osteoporosis. All other authors declare no conflict of interest. Supplementary information Supplementary information accompanies this paper at https://doi.org/10. Author details 1186/s12891-020-03495-9. Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway. Department of Kinesiology, University of Waterloo and Schlegel-UW Research Institute for Aging, Waterloo, Canada. School of Additional file 1. CONSORT 2010 checklist of information to include Health and Life Sciences, Institute of Applied Health Research, Centre for when reporting a randomised trial. Living, Glasgow Caledonian University, Glasgow, UK. Additional file 2. Detailed description of the intervention following the CERT-guidelines. Received: 1 April 2020 Accepted: 8 July 2020 Abbreviations References 30STS: 30-s sit to stand; 6MWT: 6-min walk test; DXA: Dual-energy x-ray ab- 1. Cauley JA. Public health impact of osteoporosis. J Gerontol A Biol Sci Med sorptiometry technology; FES-I: Falls Efficacy Scale International; Sci. 2013;68(10):1243–51. FR: Functional reach; FSST: Four Square Step Test; HRQoL: Health-related 2. Svedbom A, Hernlund E, Ivergard M, Compston J, Cooper C, Stenmark J, quality of life; IPAQ-SF: International Physical Activity Questionnaire Short McCloskey EV, Jonsson B, Kanis JA. 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BMC Musculoskeletal Disorders – Springer Journals

Published: Jul 18, 2020

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