Impact of Exercise on Older Persons With Osteoarthritis

NCT ID: NCT00000434

Last Updated: 2019-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

1983-12-31

Study Completion Date

2003-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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.

Group Type EXPERIMENTAL

Fit and Strong!

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

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

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Center for Research on Health and Aging, UIC

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susan Hughes

Role: PRINCIPAL_INVESTIGATOR

Center for Research on Health and Aging

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

North Park Village

Chicago, Illinois, United States

Site Status

Bernard Horwich Jewish Community Center

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15075418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17169935 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIAMS-050

Identifier Type: -

Identifier Source: secondary_id

P60AR030692

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Combined Exercise Trial
NCT04848038 ACTIVE_NOT_RECRUITING NA
Healthy Aging Through Optimized Exercise
NCT07093216 NOT_YET_RECRUITING NA