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Completed

NCT Number: NCT00000434

Impact of Exercise on Older Persons With Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis Adherence Interventions Arthritis Behavior Health Behavior Health Education Joint Diseases Medication Adherence Musculoskeletal Diseases Patient Acceptance of Health Care Patient Compliance Rheumatic Diseases Treatment Adherence and Compliance

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bernard Horwich Jewish Community Center, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fit and Strong!

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.

Primary outcomes

  1. Adherence to exercise

    Time frame: 12 months

Secondary outcomes

  1. Pain and stiffness

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Impact of Exercise on Older Persons With Osteoarthritis (OA)

Important dates

Study start
1983
Primary completion
2003
Study completion
2003
First posted
Jan 24, 2000
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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