Build Better Bones With Exercise (B3E)

University of Waterloo

Status: Completed

Conditions: Spinal Fractures; Osteoporotic Fractures

Treatments: Behavioral: Exercise and behaviour change strategies

Study type: Interventional

Funder types: Other

Identifiers

NCT01761084

18539

Details and patient eligibility

About

The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. 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. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%.

Full description

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 randomized controlled trial (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 studies 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.

Enrollment: 141 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a) a known or suspected vertebral fracture of non-traumatic etiology OR b) one of the following:

  • documented height loss of ≥2cm
  • historical height loss of ≥6cm
  • visible hyperkyphosis

• age greater than or equal to 65 years of age

• able to understand instructions in english

• able to give informed consent (no cognitive impairment)

Exclusion criteria

• Current or prior cancer
• On dialysis, known liver, kidney or malabsorption disease
• Progressive neurological disorder, unable to stand or walk for 10 metres, with/without gait aid or progressive disorder likely to prevent study completion, palliative care.
• Current participation in muscle strengthening or similar exercise program ≥ 3 times per week
• Uncontrolled hypertension or other contraindications to exercise

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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141 participants in 2 patient groups

Exercise and behaviour change strategies

Experimental group

Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Treatment:

Behavioral: Exercise and behaviour change strategies

General health or social discussion

No Intervention group

Description:

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.