Clinical trial NCT00592813: Efficacy of a Post-Rehabilitation Exercise Intervention
Official title: Efficacy of a Post-Rehabilitation Exercise Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Disability
Keywords: rehabilitation
function
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Spaulding Rehabilitation Hospital
First posted: 2008-01-14
Enrollment: 232
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 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.

Primary outcomes:
measure: 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.
timeFrame: baseline, 6-month and 9-month follow up
Secondary outcomes:
measure: 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.
timeFrame: baseline, 6-month and 9-month follow up
measure: 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.
timeFrame: baseline, 6-month and 9-month follow up
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Health & Disability Research Institute
name: Alan M Jette, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Health & Disability Research Institute
name: Nancy Latham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Latham NK, Harris BA, Bean JF, Heeren T, Goodyear C, Zawacki S, Heislein DM, Mustafa J, Pardasaney P, Giorgetti M, Holt N, Goehring L, Jette AM. Effect of a home-based exercise program on functional recovery following rehabilitation after hip fracture: a randomized clinical trial. JAMA. 2014 Feb 19;311(7):700-8. doi: 10.1001/jama.2014.469.