Completed

Impact of Exercise on Older Persons With Osteoarthritis (OA)

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What is being tested

Fit and Strong!

Behavioral
Who is being recruted

Treatment Adherence and Compliance+10

+ Adherence Interventions

+ Arthritis

Over 60 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: December 1983
See protocol details

Summary

Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: August 22, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1983

Actual date on which the first participant was enrolled.

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.

NCT00000434
Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: August 22, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

217 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Treatment Adherence and ComplianceAdherence InterventionsArthritisBehaviorJoint DiseasesMusculoskeletal DiseasesPatient Acceptance of Health CarePatient ComplianceRheumatic DiseasesHealth BehaviorMedication AdherenceHealth EducationOsteoarthritis

Criteria

4 inclusion criteria required to participate
60 years of age or older

Lack of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire

No other contraindication from a personal physician for participation in the fitness walking

Presence of osteoarthritis of the lower extremities with an American College of Rheumatology functional class rating of I, II, or III

11 exclusion criteria prevent from participating
Complicated knee or hip surgery within previous year

Contraindication from a personal physician for participation in fitness walking

Current participation in a structured aerobic exercise program

Diabetes that is not under control

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

North Park Village

Chicago, United StatesOpen North Park Village in Google Maps

Bernard Horwich Jewish Community Center

Chicago, United States
Completed2 Study Centers