Exercise Adherence Among Older Adults With Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60608
- Center for Research on Health and Aging
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 60 years of age or older
- Presence of osteoarthritis in the lower extremities (including hip, knee, ankle, feet and lower back) with an American College of Rheumatology functional class rating of I, II, or III
- No other contraindication from a personal physician for participation in fitness walking or low-impact aerobics and strength training
- Lack of moderate to severe cognitive impairment shown as assessed by the Short Portable Mental Status Questionnaire
Exclusion Criteria:
- Under 60 years of age
- Lack of osteoarthritis in the lower extremities
- Contraindication from a personal physician for participation in activities described above
- Presence of moderate to severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
- Steroid injections in either knee or hip within previous six months
- Knee or hip surgery within previous six months
- Plans for total knee or hip replacement within the next year
- Rheumatoid arthritis or other system inflammatory arthritis
- Diabetes that is not under good control
- Current participation in a structured aerobic exercise program
- Participation in original trial of the Fit and Strong Program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
Treatment Arm A will develop tailored/negotiated contracts with the exercise instructor to maintain post intervention exercise adherence at home or in the community.
Half of the participants in this "negotiated maintenance" arm will be randomly assigned to receive telephone calls to reinforce adherence and half will be assigned to a no telephone calls group.
|
Fit 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.
|
|
Experimental: B
Treatment Arm B will be mainstreamed into an ongoing facility-based exercise program for post intervention exercise adherence.
Persons in this "mainstream follow up" arm will be randomly assigned such that half will receive regular telephone reinforcement follow up and half will not.
|
Fit 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maintenance of exercise behavior measured by CHAMPS (Community Healthy Activities Model Program For Seniors)
Time Frame: Baseline, 2 months, 6 months, 12 months, 18 months
|
Baseline, 2 months, 6 months, 12 months, 18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in lower extremity strength (timed sit-stand test)
Time Frame: Baseline, 2 months, 6 months, 12 months, 18 months
|
Baseline, 2 months, 6 months, 12 months, 18 months
|
|
Aerobic capacity (6 minute distance walk)
Time Frame: Baseline, 2 months, 6 months, 12 months, 18 months
|
Baseline, 2 months, 6 months, 12 months, 18 months
|
|
Pain, stiffness, physical function subscales measured by WOMAC (Western Ontario and McMaster osteoarthritis index)
Time Frame: Baseline, 2 months, 6 months, 12 months, 18 months
|
Baseline, 2 months, 6 months, 12 months, 18 months
|
|
Functional ability measured by GeriAIMS (Geriatric Arthritis Impact Measurement Scale)
Time Frame: Baseline, 2 months, 6 months, 12 months, 18 months
|
Baseline, 2 months, 6 months, 12 months, 18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Susan Hughes, DSW, Center for Research on Health and Aging , University of Illinois, Chicago
Publications and helpful links
General Publications
- Hughes SL, Seymour RB, Campbell R, Pollak N, Huber G, Sharma L. Impact of the fit and strong intervention on older adults with osteoarthritis. Gerontologist. 2004 Apr;44(2):217-28. doi: 10.1093/geront/44.2.217.
- Hughes SL, Seymour RB, Campbell RT, Huber G, Pollak N, Sharma L, Desai P. Long-term impact of Fit and Strong! on older adults with osteoarthritis. Gerontologist. 2006 Dec;46(6):801-14. doi: 10.1093/geront/46.6.801.
- Seymour RB, Hughes SL, Campbell RT, Huber GM, Desai P. Comparison of two methods of conducting the Fit and Strong! program. Arthritis Rheum. 2009 Jul 15;61(7):876-84. doi: 10.1002/art.24517.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG0075
- 5R01AG023424 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.