Clinical trial NCT00421681: Exercise Adherence Among Older Adults With Osteoarthritis
Official title: Exercise Adherence Among Older Adults With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: Aging
exercise
health behavior
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 2007-01-12
Enrollment: 600
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maintenance of exercise behavior measured by CHAMPS (Community Healthy Activities Model Program For Seniors)
timeFrame: Baseline, 2 months, 6 months, 12 months, 18 months
Secondary outcomes:
measure: Changes in lower extremity strength (timed sit-stand test)
timeFrame: Baseline, 2 months, 6 months, 12 months, 18 months
measure: Aerobic capacity (6 minute distance walk)
timeFrame: Baseline, 2 months, 6 months, 12 months, 18 months
measure: Pain, stiffness, physical function subscales measured by WOMAC (Western Ontario and McMaster osteoarthritis index)
timeFrame: Baseline, 2 months, 6 months, 12 months, 18 months
measure: Functional ability measured by GeriAIMS (Geriatric Arthritis Impact Measurement Scale)
timeFrame: Baseline, 2 months, 6 months, 12 months, 18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Center for Research on Health and Aging
state: Illinois
Study officials:
affiliation: Center for Research on Health and Aging , University of Illinois, Chicago
name: Susan Hughes, DSW
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.