Exercise Adherence Among Older Adults With Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Exercise Adherence Among Older Adults With Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00421681
• Other study ID #: AG0075
• Secondary ID: 5R01AG023424
• Status: Active, not recruiting
• Phase: N/A
• First received: January 10, 2007
• Last updated: December 10, 2009
• Start date: October 2003
• Est. completion date: September 2008

Study information

• Verified date: January 2008
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Center for Research on Health and Aging	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of exercise behavior measured by CHAMPS (Community Healthy Activities Model Program For Seniors)		Baseline, 2 months, 6 months, 12 months, 18 months	No
Secondary	Changes in lower extremity strength (timed sit-stand test)		Baseline, 2 months, 6 months, 12 months, 18 months	No
Secondary	Aerobic capacity (6 minute distance walk)		Baseline, 2 months, 6 months, 12 months, 18 months	No
Secondary	Pain, stiffness, physical function subscales measured by WOMAC (Western Ontario and McMaster osteoarthritis index)		Baseline, 2 months, 6 months, 12 months, 18 months	No
Secondary	Functional ability measured by GeriAIMS (Geriatric Arthritis Impact Measurement Scale)		Baseline, 2 months, 6 months, 12 months, 18 months	No