Build Better Bones With Exercise

Not Applicable

Completed

Conditions: Osteoporotic Fractures
Spinal Fractures

Interventions: Behavioral: Exercise and behaviour change strategies

Registration Number: NCT01761084

Lead Sponsor: University of Waterloo

Brief Summary: 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%.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 141

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise and behaviour change strategies	Exercise and behaviour change strategies	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of Recruitment and Retention	Monthly records up to 12 months.	Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.
Adherence	Monthly records over 12 months	Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence.

Secondary Outcome Measures

Name	Time	Method
Scores on Exercise Self-efficacy Scales.	Baseline, 6 months and one year.	To assess self-efficacy related to engaging in exercise, participants will be asked "Over the next 3 months, how confident are you that you can perform exercise on most days of the week?" and "Over the next 3 months, how confident are you that you can perform exercise on 3 days of the week?." To assess implementation intentions, participants are asked "Do you already have concrete plans regarding exercise?". Patients will rate their answers on a scale from 1-5. Higher scores indicate greater exercise self-efficacy.
Productivity	Monthly up to one year.	Questionnaire regarding much did the participant's spine fracture(s) or osteoporosis affect their productivity while working? The scale is 0-10, with higher numbers indicating more effect on their work.
Number of Serious Adverse Events.	Monthly up to one year.	Defined as death or event that is life-threatening, requires hospitalization or results in disability.
Occiput to Wall Distance	Baseline and one year.
Number of Fractures.	Baseline, one year and at report of fracture (monitored monthly for reports).	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 Fallers	Monthly up to one year.	Diary for participants to self-report falls.
Score on Short-form Falls Efficacy Scale International (FES-I).	Baseline, 6 months and one year.	Questionnaire about how concerned the participant is about the possibility of falling during common daily activities. Scores range from 7 (no concern about falling) to 28 (severe concern about falling.
Physical Activity	Baseline, 6 months, 12 months	A modified version of the Short-Form International Physical Activity Questionnaire (IPAQ) will be completed. A subset of participants at the University of Waterloo (St. Mary's General Hospital) will wear an accelerometer for 7 days.
Value of Non-direct Medical Resources Per Participant.	Accrued costs over 12 months
Activities of Daily Living	Monthly up to one year	0-10 scale about ability to do activities of daily living. Higher scores indicate more difficulty.
Timed Loaded Standing Test	Baseline and one year	A physical performance measure of combined trunk and arm endurance.
Value of Direct Medical Resources Per Participant.	Accrued costs over 12 months
Participant Height	Baseline and one year
Participant Weight	Baseline and Month 12
Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).	Baseline and one year.	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. The sub-scores of which are added to create a composite score (0-16), with higher scores indicating better performance.
Number of Potentially Eligible Males	over recruitment period
Number of Participants With Multiple Falls	Monthly up to 12 months.
Location of Vertebral Fractures	Baseline and Month 12	Any vertebral fracture (Genant Grade 1 or higher) found on x-ray, divided into location groupings of T1-T3, T4-T8, T9-L1, and L2-L5.
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 (VAS).	Baseline, 6 months and one year.	OQLQ scores range 1-7, with higher scores indicate greater quality of life. EQ5D5L VAS scores range 0-100, with higher scores indicating better overall health. VAS pain scores range 0-10, with lower scores indicating less pain.
Number of Individuals Screened and Eligible Per Collection Site.	over the course of the study (2.29 years)	Number of participants randomized out of all participants screened
Total Number of Falls	Monthly up to 12 months.
Scores on the Short Physical Performance Battery (SPPB)	Baseline and one year.	The SPPB consists of balance tests (side-by-side, semi-tandem, and tandem standing), gait speed during 4-meter walk test, and the average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test), sub-scores of which are added to determine a composite score (0-12), with higher scores indicative of better performance.