Build Better Bones With Exercise: Protocol for a Feasibility Study of a Multicenter Randomized Controlled Trial of 12 Months of Home Exercise in Women With a Vertebral Fracture
Open Access
- 1 September 2014
- journal article
- research article
- Published by Oxford University Press (OUP) in PTJ: Physical Therapy & Rehabilitation Journal
- Vol. 94 (9), 1337-1352
- https://doi.org/10.2522/ptj.20130625
Abstract
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.Keywords
This publication has 76 references indexed in Scilit:
- Exercise for improving outcomes after osteoporotic vertebral fractureEmergencias, 2013
- Interventions for preventing falls in older people living in the communityEmergencias, 2012
- Optimizing the Tracking of Falls in Studies of Older Participants: Comparison of Quarterly Telephone Recall With Monthly Falls Calendars in the MOBILIZE Boston StudyAmerican Journal of Epidemiology, 2010
- Effective Exercise for the Prevention of Falls: A Systematic Review and Meta‐AnalysisJournal of the American Geriatrics Society, 2008
- Shifting the focus in fracture prevention from osteoporosis to fallsBMJ, 2008
- The vertebral fracture cascade in osteoporosis: a review of aetiopathogenesisOsteoporosis International, 2007
- The effect of osteoporotic vertebral fracture on predicted spinal loads in vivoEuropean Spine Journal, 2006
- Bone Mineral Density Thresholds for Pharmacological Intervention to Prevent FracturesArchives of Internal Medicine, 2004
- Interventions for preventing falls in elderly peoplePublished by Wiley ,2003
- Efficacy of home-based exercise for improving quality of life among elderly women with symptomatic osteoporosis-related vertebral fracturesOsteoporosis International, 2003