Efficacy of a Post-Rehabilitation Exercise Intervention - Full Text View

Sponsors and Collaborators:	Boston University National Institute of Nursing Research (NINR)
Information provided by:	Boston University
ClinicalTrials.gov Identifier:	NCT00592813

Purpose

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:

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.

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. Secondary outcomes include disability, self-efficacy, balance, strength, cognition, and HRQoL. Adherence to the exercise program and adverse events will also be monitored.

Condition	Intervention
Hip Fracture Disability	Behavioral: Enhanced Strong for Life

MedlinePlus related topics: Exercise and Physical Fitness Fractures Hip Injuries and Disorders Hip Replacement Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:	Efficacy of a Post-Rehabilitation Exercise Intervention

Further study details as provided by Boston University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
2. The SFL program will significantly improve health-related quality of life among participants at 6-month follow-up. [ Time Frame: baseline, 6-month and 9-month follow up ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	230
Study Start Date:	April 2008
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: No Intervention

Arms

Assigned Interventions

1: Experimental

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.

2: No Intervention

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592813

Contacts

Contact: Jonathan Bean, MD	(617) 573-2700	jfbean@partners.org
Contact: Siphannay Nhean, BA	617 638 1993	snhean@bu.edu

Locations

United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States

Sponsors and Collaborators

Boston University

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator:

Alan M Jette, PhD

Health & Disability Research Institute

More Information

No publications provided

Responsible Party:	Health & Disability Research Institute ( Alan M. Jette, Director )
Study ID Numbers:	1R01NR010815-01A2, 1R01NR010815-01A2
Study First Received:	January 2, 2008
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00592813 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston University:

rehabilitation
function

Study placed in the following topic categories:

Hip Fractures
Femoral Fractures
Fractures, Bone

Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

Additional relevant MeSH terms:

Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on May 07, 2009