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| Sponsors and Collaborators: |
University of British Columbia Michael Smith Foundation for health research |
|---|---|
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00795028 |
Purpose
Patients who have suffered a first hip fracture have a higher risk of falling and sustaining another hip fracture compared with age-matched adults who did not fracture. Although exercise is key to reversing this pattern, there have been very few trials that aimed to improve muscle strength and balance as well as enhance bone health following hip fracture. Therefore, we propose to conduct an RCT that delivers either 12 months of standard care or standard care plus graduated exercise program for older women who have sustained a recent hip fracture.
| Condition | Intervention |
|---|---|
|
Hip Fracture |
Other: Exercise intervention: Strength training Other: Standard Care for people after hip fracture |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment |
| Official Title: | Preventing Falls and Disability in Older Adults After Hip Fracture |
| Estimated Enrollment: | 174 |
| Study Start Date: | February 2009 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Standard Care for people after a hip fracture
|
Other: Standard Care for people after hip fracture |
|
2: Experimental
Standard Care + exercise intervention: Participants will receive a graduated twice-weekly balance and strength exercise program (MASTER program - Mobility And STrength Exercises for Recovery). The MASTER program will be delivered in 2 phases, first in the community and then in the home
|
Other: Exercise intervention: Strength training
PHASE 1. For the first 6 months after fracture, the MASTER program will be delivered at the Centre for Hip Health (CHH) Exercise Prescription Suite (EPS). PHASE 2. After the initial four month supervised exercise program, participants will transition into a home-based exercise rehabilitation program. (See Detailed Description for more Information) |
We propose a 1-year RCT of graduated exercise program for older women after a hip fracture versus standard care alone. We will investigate the effect of exercise on fall reduction, functional mobility and bone microarchitecture.
Primary Outcome:
Fall rate, measured by self-reported daily fall diaries, will be collected monthly at the exercise classes and followed up by a blinded, independent investigator.
Secondary Outcome:
All measures will be collected at three times over the one year program except the Physical Activities Scale for the Elderly questionnaire which will be collected on a monthly basis.
i. Functional Outcome: We will track participants' ability to perform basic and instrumental activities of daily living (ADL). Bone health: We will use conventional methods (DXA) to assess bone mineral density at the non-fractured hip and Xtreme CT to describe adaptations in bone microarchitecture in both tibiae. Physical Activity: Self-report: All participants will be asked to complete a monthly Physical Activities Scale for the Elderly questionnaire. Accelerometry. We will use uni-axial accelerometers (GT1M ActiGraph, LLC, Fort Walton Beach, FL) to obtain an objective measure of physical activity for 5 days. Muscle strength and balance: Upper and lower extremity isometric muscle strength will be tested.
Intervention Description:
PHASE 1. For the first 6 months after fracture, the MASTER program will be delivered at the Centre for Hip Health (CHH) Exercise Prescription Suite (EPS). Programs will be individualized and progressive based on the entry level competency of each participant. Resistance exercises will utilize body weight, elastic bands and free weights. The number of sets participants complete and the resistance for each exercise will be recorded at every session. All participants will be asked to wear hip protectors during exercise classes at the CHH.
PHASE 2. After the initial four month supervised exercise program, participants will transition into a home-based exercise rehabilitation program. This program will consist of 30-minutes of exercises, twice a week designed to increase and maintain participants' balance and muscle strength. Exercises will be a logical progression of the PHASE 1 program and Theraband and free weights will be provided for home use. During the home-based exercise phase, a research assistant will visit each participant in their home 5 times to aid in the progression of the program and to provide feedback and encouragement.
Eligibility| Ages Eligible for Study: | 65 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Erin Gorman | 604-875-4111 ext 69058 | Maureen.ashe@exchange.ubc.ca |
| Canada, British Columbia | |
| Centre for Hip Health & Mobility - Vancouver Coastal Health Research Institute | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Principal Investigator: | Maureen Ashe, PhD | University of British Columbia |
More Information
| Responsible Party: | University of British Columbia ( Dr. Maureen Ashe ) |
| Study ID Numbers: | H08-01685 |
| Study First Received: | November 20, 2008 |
| Last Updated: | November 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00795028 |
| Health Authority: | Canada: Health Canada |
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older women hip fracture exercise intervention |
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Hip Fractures Femoral Fractures Fractures, Bone |
Wounds and Injuries Disorders of Environmental Origin Leg Injuries |
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Hip Injuries |
