Build Better Bones With Exercise (B3E)

• Feasibility of recruitment and retention [ Time Frame: Monthly records up to 12 months. ] [ Designated as safety issue: No ]
  Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.
  
  
• Adherence [ Time Frame: Monthly records over 12 months ] [ Designated as safety issue: No ]
  Number of exercise sessions completed relative to prescribed. We will use a calendar for participants to self-report adherence.
  
  

• Number and location of fractures. [ Time Frame: Baseline, one year and at report of fracture (monitored monthly for reports). ] [ Designated as safety issue: Yes ]
  Incident fracture will be a composite outcome of a vertebral fracture or fragility fracture (excluding fractures due to trauma or cancer). A fracture questionnaire will be used to ascertain the occurrence of fractures, the approximate timing and the cause with fracture occurrence, location and severity verified through health record data. Lateral thoracic and lumbar spine x-rays will be performed on participants at baseline (to confirm prevalent vertebral fractures) and follow-up (to identify new fractures). Vertebral fractures will be defined as radiographic presence of ≥25% reduction in anterior, middle or posterior height of a vertebra using the Genant visual semi-quantitative method.
  
  
• Number of falls. [ Time Frame: Monthly up to one year. ] [ Designated as safety issue: Yes ]
  We will use a falls calendar for participants to self-report falls.
  
  
• Occiput to wall distance [ Time Frame: Baseline and one year. ] [ Designated as safety issue: No ]
  
• Average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test). [ Time Frame: Baseline and one year. ] [ Designated as safety issue: No ]
  
• Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER). [ Time Frame: Baseline and one year. ] [ Designated as safety issue: No ]
  Balance Outcome Measure for Elder Rehabilitation (BOOMER) includes the step test, the Timed Up and Go, the Functional Reach test and the timed static stance feet together eyes closed test. We will also look at changes in these outcomes individually.
  
  
• Gait speed during 4-meter walk test. [ Time Frame: Baseline and one year. ] [ Designated as safety issue: No ]
  
• Quality of Life (QoL) and Pain scores measured through the EuroQOL instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale. [ Time Frame: Baseline, 6 months and one year. ] [ Designated as safety issue: No ]
  
• Scores on exercise self-efficacy scales. [ Time Frame: Baseline, 6 months and one year. ] [ Designated as safety issue: No ]
  To assess self-efficacy related to engaging in exercise, patients will be asked "Over the next 3 months, how confident are you to participate in an exercise program for 30 minutes for at least 3 days per week". To assess implementation intentions, patients are asked "Do you have a plan to start an exercise program at least 3 times a week for the next 3 months". Patients will rate their answers on a scale from 1-5 or 1-10.
  
  
• Score on Short-form Falls Efficacy Scale International (FES-I). [ Time Frame: Baseline, 6 months and one year. ] [ Designated as safety issue: No ]
  
• Workplace Productivity and Activity Index. [ Time Frame: Baseline, 6 months and one year. ] [ Designated as safety issue: No ]
  
• Total physical activity [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  Estimated as the average minutes reported on an activity log at baseline and during the two weeks prior to assessments. A subset of participants will wear an accelerometer for 7 days at baseline and follow-up.
  
  
• Number of adverse events per participant. [ Time Frame: Monthly up to one year. ] [ Designated as safety issue: Yes ]
  Defined as death or event that is life-threatening, requires hospitalization or results in disability.
  
  
• Number of individuals screened and eligible per collection site. [ Time Frame: over 1 year ] [ Designated as safety issue: No ]
  
• Number of potentially eligible males [ Time Frame: over 1 year of recruitment ] [ Designated as safety issue: No ]
  
• Number of multiple fallers. [ Time Frame: Monthly up to 12 months. ] [ Designated as safety issue: Yes ]
  
• Falls rate. [ Time Frame: Monthly up to 12 months. ] [ Designated as safety issue: Yes ]
  
• Value of direct medical resources per participant. [ Time Frame: Baseline, 6 months and one year. ] [ Designated as safety issue: No ]
  
• Value of non-direct medical resources per participant. [ Time Frame: Baseline, 6 months and one year. ] [ Designated as safety issue: No ]
  
• Height [ Time Frame: Baseline and one year ] [ Designated as safety issue: No ]
  

There is limited data available from which to develop guidelines for safe and effective exercise prescription among individuals with hip or vertebral fractures. The long-term goal of our research team is to conduct a large multi-centre RCT to investigate whether participating in a thrice-weekly home exercise program for one year can reduce incident fragility fractures among women aged 65 years or older with a history of vertebral fracture compared to no intervention. The current study is a pilot study with the principal objective of determining the feasibility of recruitment, retention and adherence of an international multicentre RCT evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. The intervention was developed by experts in exercise prescription based on a rigorous literature review and Cochrane meta-analysis we have conducted. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. Secondary outcomes of the pilot study are those hypothesized to be among the causal pathway linking exercise to fracture risk, including lower extremity strength, posture, balance, as well as falls and fractures. Additional secondary outcomes include quality of life, pain, exercise self-efficacy, the cost of the intervention, and the risk of adverse events associated with exercise. The recruitment and retention process will be summarized using a CONSORT flow diagram, and the reporting of results will be in accordance with the CONSORT criteria. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to criteria defined a priori. Differences in secondary outcomes will be evaluated in intention to treat analyses via independent student T-tests, Chi Square or logistic regression. The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall level is alpha=0.05. Even if the larger trial proves not to be feasible, the current trial will be one of the largest exercise study among a representative group of women with vertebral fracture to date, and will evaluate the feasibility and costs of a comprehensive home exercise program, and its effect on important secondary outcomes. Osteoporosis Canada has defined a need to develop patient resources on exercise and recently announced a shift in priority to individuals with existing fractures; the proposed pilot study is timely and will directly inform these knowledge translation initiatives.