Impact of Exercise on Older Persons With Osteoarthritis - Full Text View

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator:	National Institute on Aging (NIA)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00000434

Purpose

Previous studies have found that exercise can reduce pain, improve endurance for physical activities, and improve cardiovascular fitness over time. However, these studies have not looked at the impact of exercise programs for older adults with osteoarthritis or at how long older adults continue exercising after a program is finished. This study will look at the long-term effects of a structured exercise program for people aged 60 or older who have osteoarthritis of the hip or knee. One goal of the exercise program is to encourage older people with osteoarthritis to continue exercising.

We will randomly assign study participants to either the exercise program or a control group that does not do the exercise program. We will monitor participants at the start of the study, at 8 weeks, and every 3 months for 2 years after the program is completed. The exercise program lasts for 8 weeks and includes an exercise part and an educational part led by trained physical therapists. We believe that participants in the treatment (exercise) group will show higher rates of continued exercise and higher functional status over time compared to the group of people who do not participate in the exercise program.

Condition	Intervention	Phase
Osteoarthritis	Behavioral: Fit and Strong!	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Impact of Exercise on Older Persons With Osteoarthritis (OA)

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Osteoarthritis

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Adherence to exercise [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain and stiffness [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	217
Study Start Date:	December 1983
Study Completion Date:	September 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fit and Strong! is a multi-component exercise and health education program that incorporates flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change.	Behavioral: Fit and Strong! Fit and Strong! is a multi-component exercise and health education program that includes flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change.

Detailed Description:

Recent exercise interventions have demonstrated statistically significant short-term improvements in muscle strength, fitness, and physical activity in people under the age of 70. This study seeks to determine if those same benefits can be achieved in an older population (mean age 84) with osteoarthritis of the hip or knee. The study will examine the long-term effects of a structured exercise program that seeks to promote adherence to continued exercise.

We will randomly assign people who meet the study criteria to the exercise intervention or control group. We will conduct measures at baseline, at 8 weeks, and at 3-month intervals for 2 years following the intervention. The exercise component of the intervention will include lower extremity muscle strengthening, range-of-motion exercises, and fitness walking. An educational component will focus on arthritis self-efficacy and perceived self-reported exercise efficacy. We hypothesize that treatment group participants will exhibit higher rates of adherence to exercise and higher functional status outcomes over time compared to controls.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

60 years of age or older
Presence of osteoarthritis of the lower extremities with an American College of Rheumatology functional class rating of I, II, or III
No other contraindication from a personal physician for participation in the fitness walking
Lack of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire

Exclusion Criteria:

Under 60 years of age
Lack of osteoarthritis of the lower extremities
Contraindication from a personal physician for participation in fitness walking
Presence of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
Steroid injections in either hip or knee within the previous 6 months
Uncomplicated knee or hip surgery within previous year
Complicated knee or hip surgery within previous year
Plans for total knee or hip replacement within the next year
Rheumatoid arthritis or other systemic inflammatory arthritis
Diabetes that is not under control
Current participation in a structured aerobic exercise program

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000434

Locations

United States, Illinois
North Park Village
Chicago, Illinois, United States, 60646
Bernard Horwich Jewish Community Center
Chicago, Illinois, United States, 60659

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Susan Hughes

Center for Research on Health and Aging

More Information

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.

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.

Responsible Party:	Center for Research on Health and Aging, UIC ( Susan Hughes )
Study ID Numbers:	P60 AR30692, NIAMS-050
Study First Received:	January 21, 2000
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00000434 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Osteoarthritis
Health education
Aerobic exercise
Self-efficacy

Muscle strength
Outcomes research
Longitudinal study

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 09, 2009