Build Better Bones With Exercise

Osteoporotic Fractures Clinical Trial

— B3E  

Official title:

Build Better Bones With Exercise: A Pilot Randomized Controlled Trial of Exercise in Women With Osteoporotic Vertebral Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761084
• Other study ID #: 18539
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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 information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporotic Fractures
• Spinal Fractures

Intervention

Behavioral:
• Exercise and behaviour change strategies
cardiovascular exercise (e.g., marching, walking) for =10 minutes per day postural retraining and balance exercises =3 days a week (will be encouraged to do these daily) perform muscle strengthening and balance training exercises = 3 days a week the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (7)

Lead Sponsor	Collaborator
University of Waterloo	Canadian Institutes of Health Research (CIHR), McMaster University, University Health Network, Toronto, University of British Columbia, University of Melbourne, University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Recruitment and Retention	Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.	Monthly records up to 12 months.
Primary	Adherence	Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence.	Monthly records over 12 months
Secondary	Number of Fractures.	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.	Baseline, one year and at report of fracture (monitored monthly for reports).
Secondary	Number of Fallers	Diary for participants to self-report falls.	Monthly up to one year.
Secondary	Occiput to Wall Distance		Baseline and one year.
Secondary	Scores on the Short Physical Performance Battery (SPPB)	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.	Baseline and one year.
Secondary	Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).	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.	Baseline and one year.
Secondary	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).	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.	Baseline, 6 months and one year.
Secondary	Scores on Exercise Self-efficacy Scales.	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.	Baseline, 6 months and one year.
Secondary	Score on Short-form Falls Efficacy Scale International (FES-I).	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.	Baseline, 6 months and one year.
Secondary	Productivity	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.	Monthly up to one year.
Secondary	Physical Activity	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.	Baseline, 6 months, 12 months
Secondary	Number of Serious Adverse Events.	Defined as death or event that is life-threatening, requires hospitalization or results in disability.	Monthly up to one year.
Secondary	Number of Individuals Screened and Eligible Per Collection Site.	Number of participants randomized out of all participants screened	over the course of the study (2.29 years)
Secondary	Number of Potentially Eligible Males		over recruitment period
Secondary	Number of Participants With Multiple Falls		Monthly up to 12 months.
Secondary	Total Number of Falls		Monthly up to 12 months.
Secondary	Value of Direct Medical Resources Per Participant.		Accrued costs over 12 months
Secondary	Value of Non-direct Medical Resources Per Participant.		Accrued costs over 12 months
Secondary	Participant Height		Baseline and one year
Secondary	Activities of Daily Living	0-10 scale about ability to do activities of daily living. Higher scores indicate more difficulty.	Monthly up to one year
Secondary	Timed Loaded Standing Test	A physical performance measure of combined trunk and arm endurance.	Baseline and one year
Secondary	Location of Vertebral Fractures	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.	Baseline and Month 12
Secondary	Participant Weight		Baseline and Month 12

External Links

•   Principal Investigator