Efficacy of a Post-Rehabilitation Exercise Intervention

Hip Fracture Clinical Trial

Official title:

Efficacy of a Post-Rehabilitation Exercise Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592813
• Other study ID #: NINR 1R01NR010815-01A2
• Secondary ID: 1R01NR010815-01A
• Status: Completed
• Phase: N/A
• First received: January 2, 2008
• Last updated: April 22, 2013
• Start date: April 2008
• Est. completion date: November 2012

Study information

• Verified date: April 2013
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disability
• Hip Fracture
• Hip Fractures

Intervention

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.
• cardiovascular nutrition education
administered as an attention control intervention using home visits, phone calls and mail-outs of information

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Cambridge	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	National Institute of Nursing Research (NINR), Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	performance based function is assessed using the Short Physical Performance Battery (SPPB) and self-reported function is assessed using the AM-PAC	baseline, 6-month and 9-month follow up	No
Secondary	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.		baseline, 6-month and 9-month follow up	No
Secondary	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.		baseline, 6-month and 9-month follow up	No