Exercise Adherence Among Older Adults With Osteoarthritis
NCT ID: NCT00421681
Last Updated: 2009-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2003-10-31
2008-09-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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! Exercise Program
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.
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! Exercise Program
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.
Interventions
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Fit and Strong! Exercise Program
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Responsible Party
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Center for Research on Health and Aging, Institute for Health Research and Policy, University of Illinois Chicago
Principal Investigators
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Susan Hughes, DSW
Role: PRINCIPAL_INVESTIGATOR
Center for Research on Health and Aging , University of Illinois, Chicago
Locations
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Center for Research on Health and Aging
Chicago, Illinois, United States
Countries
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References
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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.
Other Identifiers
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AG0075
Identifier Type: -
Identifier Source: org_study_id