Clinical Trials Directory

Trials / Unknown

UnknownNCT00421681

Exercise Adherence Among Older Adults With Osteoarthritis

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
600 (estimated)
Sponsor
National Institute on Aging (NIA) · NIH
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to assess the comparative effects of two different ways of enhancing long-term adherence to and benefits associated with participation in the evidence-based, Fit and Strong multi-component exercise intervention for older persons with lower extremity osteoarthritis.

Detailed description

Osteoarthritis (OA) is the most common condition affecting older people today. It is the leading cause of disability among older people and its impact is projected to increase substantially with the aging of the U.S population from 43 million currently to 60 million by 2020. Promising 2- and 6-month outcomes have recently been reported from a randomized trial of a multi-component exercise intervention targeted at older adults with lower extremity OA. The Fit and Strong intervention, developed and tested as part of the Midwest Roybal Center for Health Maintenance, coupled strength training and aerobic walking with health education for sustained behavior change. Improvements have been found in confidence in ability to exercise, confidence in ability to continue exercising over time, lower extremity stiffness, lower extremity pain, and 6-minute distance walk. Importantly, the average adherence rate in the people who participated in the exercise intervention at six months was twice that reported by controls. The specific aims of this study are to use a multi-site randomized controlled clinical trial to replicate the Fit and Strong intervention and to test the comparative effectiveness of a negotiated/tailored follow-up maintenance strategy vs. a mainstreaming, facility-based maintenance strategy, both of which will be tested with and without telephone reinforcement as an enhancement. All enrolled participants will participate in the 8-week Fit and Strong exercise program designed specifically for older adults with lower-extremity OA. Prior to the conclusion of Fit and Strong participants will be randomly assigned to one of two follow-up maintenance groups. There is no more than minimal risk associated with this program.

Conditions

Interventions

TypeNameDescription
BEHAVIORALFit and Strong! Exercise ProgramFit and Strong! is an 8-week (24 sessions) multi-component exercise and health education intervention, including flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change. Following participation in Fit and Strong!, all study participants are randomly assigned to one of 2 maintenance treatment follow-up groups.

Timeline

Start date
2003-10-01
Primary completion
2008-09-01
Completion
2008-09-01
First posted
2007-01-12
Last updated
2009-12-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00421681. Inclusion in this directory is not an endorsement.