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Effect of a resistance and balance exercise programme for women with osteoporosis and vertebral fracture: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Osteoporotic vertebral fractures are common, and are associated with reduced functioning and health related quality of life. The primary aims of this randomized controlled trial are to examine the immediate and long-term effects of a 12-weeks supervised group exercise programme on habitual walking speed in older women with osteoporosis and a history of vertebral fracture. The secondary aims are to examine the immediate and long-term effects of the exercise program on physical fitness, fear of falling and quality of life. METHODS:The study is a single-blinded randomized controlled trial. Women aged 65 years or older with osteoporosis and a history of vertebral fracture are included. The intervention group receives a 12-week multicomponent exercise programme, including resistance training combined with balance training. The control group receives usual care. Adherence to the programme will be of importance for the internal validity of the study. Participants in the exercise group who don't attend will be followed up with motivational phone calls. The primary outcome is habitual walking speed over 10 m. Secondary outcomes are health related quality of life (Qualeffo-41, SF-36), physical activity (I-PAQ), Patient Specific Functional Scale, Fear of falling (FES-1) and physical fitness (Senior Fitness test, Functional reach test, 4 square step test, grip strength). Sample size, based on the primary outcome, is 150 participants randomized into the two arms on a 1:1 allocation, including an estimated 20% drop out. Descriptive data will be reported as mean (standard deviation), median (range) or count (percent) as appropriate. The data will be analysed following the intention-to-treat principle. Between group differences in primary and secondary outcomes at 3 months follow-up will be assessed using linear regression models with respective outcome at baseline as covariate and the randomised group as factor. DISCUSSION:This trial will generate new knowledge on the effects of a multicomponent exercise programme among women over 65 years with osteoporosis and a history of vertebral fracture, knowledge that is of importance for clinicians, health managers and policy makers. TRIAL REGISTRATION:ClincialTrials.gov Identifier: NCT02781974 . Registered 18.05.16. Retrospectively registered.

SUBMITTER: Stanghelle B

PROVIDER: S-EPMC5883309 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Effect of a resistance and balance exercise programme for women with osteoporosis and vertebral fracture: study protocol for a randomized controlled trial.

Stanghelle Brita B Bentzen Hege H Giangregorio Lora L Pripp Are Hugo AH Bergland Astrid A

BMC musculoskeletal disorders 20180403 1

<h4>Background</h4>Osteoporotic vertebral fractures are common, and are associated with reduced functioning and health related quality of life. The primary aims of this randomized controlled trial are to examine the immediate and long-term effects of a 12-weeks supervised group exercise programme on habitual walking speed in older women with osteoporosis and a history of vertebral fracture. The secondary aims are to examine the immediate and long-term effects of the exercise program on physical ...[more]

PMID: 29615028

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Project description:BackgroundExercise 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.MethodsThis 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.ResultsFor 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.ConclusionThe 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 registrationClinicalTrials.gov Identifier: NCT02781974 . Registered 25.05.16. Retrospectively registered.

Project description:Our goal is to conduct a multicenter randomized controlled trial (RCT) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged ?65 years with a vertebral fracture.This pilot study will determine the feasibility of recruitment, retention, and adherence for the proposed trial.The proposed RCT will be a pilot feasibility study with 1:1 randomization to exercise or attentional control groups.Five Canadian sites (1 community hospital partnered with an academic center and 4 academic hospitals or centers affiliated with an academic center) and 2 Australian centers (1 academic hospital and 1 center for community primary care, geriatric, and rehabilitation services).One hundred sixty women aged ?65 years with vertebral fracture at 5 Canadian and 2 Australian centers will be recruited.The Build Better Bones With Exercise (B3E) intervention includes exercise and behavioral counseling, delivered by a physical therapist in 6 home visits over 8 months, and monthly calls; participants are to exercise ?3 times weekly. Controls will receive equal attention.Primary outcomes will include recruitment, retention, and adherence. Adherence to exercise will be assessed via calendar diary. Secondary outcomes will include physical function (lower extremity strength, mobility, and balance), posture, and falls. Additional secondary outcomes will include quality of life, pain, fall self-efficacy, behavior change variables, intervention cost, fractures, and adverse events. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to a priori criteria. Differences in secondary outcomes will be evaluated in intention-to-treat analyses via independent Student t tests, chi-square tests, or logistic regression. The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall alpha level is .05.No assessment of bone mineral density will be conducted. The proposed definitive trial will require a large sample size.The viability of a large-scale exercise trial in women with vertebral fractures will be evaluated, as well as the effects of a home exercise program on important secondary outcomes.

Project description:BACKGROUND:Osteoporosis and vertebral fractures represent a major health burden worldwide, and the prevalence of osteoporosis is expected to increase as the world's population ages. Suffering from vertebral fracture has a substantial impact on the individual's health-related quality of life (HRQoL), physical function and pain. Complex health challenges experienced by older people with osteoporosis and vertebral fractures call for identification of factors that may influence HRQoL, as some of these factors may be modifiable. The objective is to examine the independent associations between HRQoL, physical function and pain in older women with osteoporosis and vertebral fracture. METHODS:This study has a cross-sectional design, using data from 149 home-dwelling Norwegian women with osteoporosis and vertebral fracture, aged 65+. Data on HRQoL (Short Form 36 (SF-36), Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)), physical function (walking speed, balance and strength), pain, as well as sociodemographic information were collected. Simple linear regression analyses were conducted and multivariable regression models were fitted to investigate the associations. RESULTS:Lower levels of HRQoL were significantly associated with lower levels of physical function, measured by walking speed, and higher levels of pain. Pain was significantly associated with all of the subscales in SF-36, with the exception of Mental Health and Mental Component Score, and all the subscales of QUALEFFO-41. Walking speed was significantly associated with 5 of 8 subscales of SF-36 (except Bodily Pain, Vitality, Mental Health and Mental Component Score), and with 4 of 6 subscales of QUALEFFO-41 (except Score Pain and Mood). CONCLUSION:This study shows that pain and walking speed were, independently of one another, associated with HRQoL in older women with osteoporosis and vertebral fracture. These findings can inform clinicians and health managers about the importance of pain management and exercise interventions in health care for this group. Future research should address interventions targeting both physical function and pain with HRQoL as an outcome. REGISTRATION:ClincialTrials.gov Identifier: NCT02781974. Registered 18.05.16. Retrospectively registered.

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Effect of a resistance and balance exercise programme for women with osteoporosis and vertebral fracture: study protocol for a randomized controlled trial.

Publications

Effect of a resistance and balance exercise programme for women with osteoporosis and vertebral fracture: study protocol for a randomized controlled trial.

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