Efficacy of a Post-Rehabilitation Exercise Intervention
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ClinicalTrials.gov Identifier: NCT00592813 |
Recruitment Status :
Completed
First Posted : January 14, 2008
Last Update Posted : April 23, 2013
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Tracking Information | |||||||
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First Submitted Date ICMJE | January 2, 2008 | ||||||
First Posted Date ICMJE | January 14, 2008 | ||||||
Last Update Posted Date | April 23, 2013 | ||||||
Study Start Date ICMJE | April 2008 | ||||||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
The specific aim that this project will address is whether: Participation in the SFL program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services. [ Time Frame: baseline, 6-month and 9-month follow up ] performance based function is assessed using the Short Physical Performance Battery (SPPB) and self-reported function is assessed using the AM-PAC
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Original Primary Outcome Measures ICMJE |
The specific aim that this project will address is whether: Participation in the SFL program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services. [ Time Frame: baseline, 6-month and 9-month follow up ] | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Efficacy of a Post-Rehabilitation Exercise Intervention | ||||||
Official Title ICMJE | Efficacy of a Post-Rehabilitation Exercise Intervention | ||||||
Brief Summary | Background: Many people who have suffered a hip fracture are discharged from rehabilitation services with significant residual functional limitations and disability. We believe that a home-based exercise program that incorporates cognitive-behavioral techniques to increase exercise adherence and promote the return to daily activities could extend the benefits of formal rehabilitation for patients who have suffered a hip fracture. Specific Aims: We will conduct a 5-year multi-site randomized controlled trial in patients who have suffered a recent hip fracture and have completed all rehabilitation services. The specific aim that this project will address is whether: Participation in the Strong for Life (SFL) program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services. This study will also investigate the following secondary hypotheses:
Target population: The target population will be people aged 60 years or more who have suffered a recent traumatic hip fracture, have one or more residual functional limitations and have completed all inpatient, outpatient or homecare rehabilitation services. Intervention: We will use an enhanced version of the Strong for Life program. This home-based exercise program will include both resistance exercises using Thera-bands that will be shown on a video/DVD and weight-bearing exercises that are progressed using a step and/or a weighted vest. A cognitive-behavioral program that is customized for people recovering from hip fracture is being developed that will focus on promoting exercise adherence, decreasing fear of falling and increasing the return to daily activities in the patient's home and community. Design: A randomized controlled clinical trial will be implemented to measure the efficacy of the Strong for Life program. An attention-control intervention will be provided to all participants assigned to the control group. The outcome evaluation points are:
Outcomes: The primary outcomes will be function measured by both self-report (AM PAC) and physical performance measures (SPPB). Secondary outcomes include disability, self-efficacy, balance, strength, cognition, and reaction time. Adherence to the exercise program and adverse events will also be monitored. |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Latham NK, Harris BA, Bean JF, Heeren T, Goodyear C, Zawacki S, Heislein DM, Mustafa J, Pardasaney P, Giorgetti M, Holt N, Goehring L, Jette AM. Effect of a home-based exercise program on functional recovery following rehabilitation after hip fracture: a randomized clinical trial. JAMA. 2014 Feb 19;311(7):700-8. doi: 10.1001/jama.2014.469. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
232 | ||||||
Original Estimated Enrollment ICMJE |
230 | ||||||
Actual Study Completion Date ICMJE | November 2012 | ||||||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
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Administrative Information | |||||||
NCT Number ICMJE | NCT00592813 | ||||||
Other Study ID Numbers ICMJE | NINR 1R01NR010815-01A2 1R01NR010815-01A2 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Alan Jette, Boston University | ||||||
Study Sponsor ICMJE | Boston University | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Boston University | ||||||
Verification Date | April 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |