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
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.
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:
- Changes in function and disability at 6-month follow-up will be correlated with changes in all three proposed intermediary variables: muscle strength, balance, and self-efficacy.
- The SFL program will significantly improve health-related quality of life among participants at 6-month follow-up.
- At 9-month follow-up the SFL program will continue to have a significant impact on participants' function and disability compared to the control group.
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.
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.
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:
- T0: baseline, at the point of discharge from formal rehabilitation;
- T2: 6-month outcome assessment
- T3: 9-month follow-up
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.
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture Disability||Behavioral: Enhanced Strong for Life Behavioral: cardiovascular nutrition education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||232 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of a Post-Rehabilitation Exercise Intervention|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||November 2012|
Behavioral: Enhanced Strong for Life
The program contains 5 minutes of warm-up, 25 minutes of strengthening, and 5 minutes of cool-down exercises. The SFL program is contained on a 35 minute videotape. Subjects are instructed to increase resistance when they can perform 10 repetitions of a movement pattern without significant fatigue or loss of proper execution. Subjects are instructed to move within a comfortable range of motion.
Participants will be taught the SFL program during two home visits conducted by a physical therapist. On the first visit, the exercise techniques will be taught, modified as needed based on individual needs and practiced as necessary until proper technique is attained. Each participant will be given written guidelines for how to progress resistance of the program, how to modify the exercises and how to complete bimonthly exercise calendars.
|Placebo Comparator: cardiovascular education (attention control)||
Behavioral: cardiovascular nutrition education
administered as an attention control intervention using home visits, phone calls and mail-outs of information
- 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
- Changes in function and disability at 6-month follow-up will be correlated with changes in all three proposed intermediary variables: muscle strength, balance, and self-efficacy. [ Time Frame: baseline, 6-month and 9-month follow up ]
- At 9-month follow-up the SFL program will continue to have a significant impact on participants' function and disability compared to the control group. [ Time Frame: baseline, 6-month and 9-month follow up ]
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): NCT00592813
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Alan M Jette, PhD||Health & Disability Research Institute|
|Principal Investigator:||Nancy Latham, PhD||Health & Disability Research Institute|