Build Better Bones With Exercise (B3E)
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|ClinicalTrials.gov Identifier: NCT01761084|
Recruitment Status : Active, not recruiting
First Posted : January 4, 2013
Last Update Posted : March 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoporotic Fractures Spinal Fractures||Behavioral: Exercise and behaviour change strategies||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Build Better Bones With Exercise: A Pilot Randomized Controlled Trial of Exercise in Women With Osteoporotic Vertebral Fracture|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||March 2018|
Experimental: 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.
Behavioral: Exercise and behaviour change strategies
No Intervention: General health or social discussion
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.
- Feasibility of recruitment and retention [ Time Frame: 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 [ Time Frame: Monthly records over 12 months ]Number of exercise sessions completed relative to prescribed. We will use a diary 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). ]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. ]Diary for participants to self-report falls.
- Occiput to wall distance [ Time Frame: Baseline and one year. ]
- Scores on the Short Physical Performance Battery (SPPB) [ Time Frame: 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).
- Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER). [ Time Frame: 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. We will also look at changes in these outcomes individually.
- 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. ]
- Scores on exercise self-efficacy scales. [ Time Frame: 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.
- Score on Short-form Falls Efficacy Scale International (FES-I). [ Time Frame: Baseline, 6 months and one year. ]
- Productivity [ Time Frame: Monthly up to one year. ]Questionnaire regarding productivity
- Physical activity [ Time Frame: 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.
- Number of adverse events per participant. [ Time Frame: Monthly up to one year. ]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 ]
- Number of potentially eligible males [ Time Frame: over 1 year of recruitment ]
- Number of multiple fallers. [ Time Frame: Monthly up to 12 months. ]
- Falls rate. [ Time Frame: Monthly up to 12 months. ]
- Value of direct medical resources per participant. [ Time Frame: Baseline, 6 months and one year. ]
- Value of non-direct medical resources per participant. [ Time Frame: Baseline, 6 months and one year. ]
- Height and weight [ Time Frame: Baseline and one year ]
- Activities of Daily Living [ Time Frame: Monthly up to one year ]0-10 scale about ability to do activities of daily living
- Timed Loaded Standing Test [ Time Frame: Baseline and one year ]A physical performance measure of combined trunk and arm endurance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761084
|University of Waterloo|
|Waterloo, Ontario, Canada, N2L 3G1|
|Principal Investigator:||Lora Giangregorio, PhD||University of Waterloo|