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Impact of Exercise on Older Persons With Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fit and Strong!
Sponsored by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis focused on measuring Osteoarthritis, Health education, Aerobic exercise, Self-efficacy, Muscle strength, Outcomes research, Longitudinal study

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Park Village
  • Bernard Horwich Jewish Community Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

Adherence to exercise

Secondary Outcome Measures

Pain and stiffness

Full Information

First Posted
January 21, 2000
Last Updated
August 20, 2019
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000434
Brief Title
Impact of Exercise on Older Persons With Osteoarthritis
Official Title
Impact of Exercise on Older Persons With Osteoarthritis (OA)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 1983 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Health education, Aerobic exercise, Self-efficacy, Muscle strength, Outcomes research, Longitudinal study

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fit and Strong!
Intervention Description
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 Outcome Measure Information:
Title
Adherence to exercise
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain and stiffness
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Hughes
Organizational Affiliation
Center for Research on Health and Aging
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Park Village
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60646
Country
United States
Facility Name
Bernard Horwich Jewish Community Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60659
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15075418
Citation
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.
Results Reference
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PubMed Identifier
17169935
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. doi: 10.1093/geront/46.6.801.
Results Reference
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Learn more about this trial

Impact of Exercise on Older Persons With Osteoarthritis

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