Efficacy of a Post-Rehabilitation Exercise Intervention
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 3/30/2013 |
| Start Date: | April 2008 |
| End Date: | July 2012 |
| Contact: | Jonathan Bean, MD |
| Email: | jfbean@partners.org |
| Phone: | (617) 573-2700 |
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 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:
- T0: baseline, at the point of discharge from formal rehabilitation;
- T2: 6-month outcome assessment
- T3: 9-month follow-up
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.
Inclusion Criteria:
- Have a primary diagnosis of hip fracture;
- Aged 60 years and above;
- Have functional limitation (i.e., as determined by limitation in at least one of 9
functional tasks listed in the SF-36 physical function scale, excluding vigorous
activities);
- Have recently (i.e., within 4 weeks at baseline assessment) been discharged from
rehabilitation services;
- Be able to understand and communicate in English;
- Be able to safely and independently stand with or without the aid of a mobility
device, without needing any assistance or supervision from another person;
- Have received written clearance from their primary care physician documenting no
contra-indications for participating in the study;
- Be able to provide written informed consent.
Exclusion Criteria:
- Have serious cognitive deficits (i.e., a Mini-Mental State Examination score of less
than 20)85;
- Have severe depression (i.e., a score of 20 or greater on the Geriatric Depression
Scale)86;
- Have a terminal illness with survival expected to be less than 1 year;
- Have significant pulmonary or cardiovascular contraindications or pre-existing
conditions that preclude participating in an exercise program;
- Legally blind;
- Currently receiving rehabilitation therapy;
- Live outside of the study's catchment area in the Boston metropolitan area and
eastern Massachusetts.
We found this trial at
1
site
Spaulding Rehabilitation Hospital At Spaulding Rehabiliation Hospital Boston, our unique approach to therapy includes use...
Click here to add this to my saved trials
