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NCT00592813 · ClinicalTrials.gov registry record · NA
Efficacy of a Post-Rehabilitation Exercise Intervention
A NA study of Hip Fracture and Disability, sponsored by Boston University.
- Completed
- Registry status
- NA
- Development phase
- 232
- Enrollment target
- 1
- Study location
NCT00592813: Completed NA study of Hip Fracture and Disability, sponsored by Boston University.
NCT00592813 is a NA study of Hip Fracture and Disability that has completed, run by Boston University. The registered enrollment target is 232 participants, above the 70-participant average among 5 other Hip Fracture trials with a reported enrollment target (231% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00592813, a NA study of Hip Fracture and Disability, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- NA
- Development phase
- 232 participants
- Enrollment target
- 1
- Study location
Study 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: 1. 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. 2. The SFL program will significantly improve health-related quality of life among participants at 6-month follow-up. 3. 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. 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 recove
Primary Outcome
performance based function is assessed using the Short Physical Performance Battery (SPPB) and self-reported function is assessed using the AM-PAC
Conditions Studied
Interventions
- BEHAVIORAL Enhanced Strong for Life
- BEHAVIORAL cardiovascular nutrition education
Study Locations (1)
Massachusetts
- Spaulding Rehabilitation Hospital - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2008-04 |
| Est. Completion | 2012-11 |
| Phase | NA |
What the finished NCT00592813 record still lists
NCT00592813 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, above the 70-participant average among 5 other Hip Fracture trials with a reported enrollment target (231% higher).
The record links to 2 conditions, with Hip Fracture appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Strong for Life is the first listed.
NCT00592813 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00592813 about?
NCT00592813 is a clinical study titled "Efficacy of a Post-Rehabilitation Exercise Intervention". 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 pr...
What is the current status of trial NCT00592813?
This trial is currently completed. It is a NA study. The enrollment target is 232 participants. The study started on 2008-04. Estimated completion is 2012-11.
What conditions does trial NCT00592813 study?
This clinical trial studies the following conditions: Hip Fracture, Disability.
What interventions are being tested in trial NCT00592813?
The interventions under investigation include: Enhanced Strong for Life (BEHAVIORAL), cardiovascular nutrition education (BEHAVIORAL).
Who is sponsoring clinical trial NCT00592813?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00592813 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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