Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee

Not Applicable

Completed

• Conditions: Chronic Diseases; Osteoarthritis; Pain; Obesity
• Interventions: Other: Weight Control Nutritional Program; Other: Home-based exercise program

• Registration Number: NCT00126737
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

The purpose of this study is to determine whether a home-based exercise and weight control program applied to elderly overweight individuals with painful osteoarthritis of the knee, would result in pain reduction.

Detailed Description

Osteoarthritis (OA) is the most common chronic disease in the United States (U.S.). Arthritis is a leading chronic illness among older adults in the U.S. Approximately 40% of individuals above 60 yr of age have OA of the knee. The primary objective of the proposed study is to determine whether individuals who are overweight with OA of the knee and who complete a 24-week home-based exercise program combined with a weight control intervention program will report significantly less pain (as measured by the WOMAC) than volunteers who participate in home-based exercise (Ex) only, weight control intervention (WC) only, or standard clinical care (C). The secondary objectives of the proposed research are to determine whether overweight individuals with OA of the knee who complete the Ex+WC program, when compared to subjects who are randomly assigned to a E, WC or C groups, demonstrate significant improvement in the following health risk profile variables: (a) improved physical function (measured by the Functional Performance Inventory), (b) improved capacity to perform stair climbing and descending, (c) improved strength, (d) increased lean body mass, (e) increase in physical activity at home (measured by pedometer step count). The proposed clinical trial will utilize a prospective, randomized two by two factorial design. Descriptive and ancova statistical method will be applied for data analyses.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2005-08-02
• Study First Submitted QC: 2005-08-02
• Study First Posted: 2005-08-04
• Primary Completion: 2008-02
• Study Completion: 2008-12
• Status Verified: 2014-12
• Results First Submitted: 2014-12-02
• Results First Submitted QC: 2014-12-30
• Last Update Submitted: 2014-12-30
• Results First Posted: 2015-01-01
• Last Update Posted: 2015-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Male & female 50 years old
• Diagnosis of osteoarthritis by American College of Rheumatology criteria
• Knee radiographs of Kellgren and Lawrence grade 2-4
• American Arthritis Association functional class 1-3
• Body mass index of 27

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Exclusion Criteria

• Knee arthritis which did not meet American College of Rheumatology (ACR) OA criteria
• Unable to engage in exercise or follow instruction
• Limited shoulder range of motion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm 2	Weight Control Nutritional Program	Group assigned to a Weight Control Nutritional Program (WC).
Arm 1	Home-based exercise program	Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Arm 1	Weight Control Nutritional Program	Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Arm 3	Home-based exercise program	Group assigned to a home-based exercise program (Ex).

Primary Outcome Measures

Name	Time	Method
WOMAC Function	Between Base-line and 24 weeks	Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is used to measure pain, function, and stiffness in patients with OA of the knee. At 24 weeks post-baseline, the average change in score was measured. We used the Function Scale only for this study. The Function Scale has 17 items, the responses are in Likert scale; namely 0=No difficulty, 1=Slight, 2=Moderate, 3= Very, 4=Extremely. The total score ranges from 0 to 68, a higher score means worse functioning. A score of 68 indicates extremely difficult in functioning.
Physical Scale SF-36v	Between Base-line and 24 weeks	The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. physical health). The average change in score 24 weeks post-baseline was measured. Physical Health consists of 4 scales, Physical Function (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items). The Physical Health component is a summary measure of scales, and the scores ranges from 0 to 100, a score of 50 is the normative average of general health. Lower scores correspond to worse physical health, higher scores correspond to better physical health.
Mental Scale SF-36v	Between Base-line and 24 weeks	The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. mental health). The average change in score 24 weeks post-baseline was measured. Mental Health component consisted of 4 scales; these are the scales: Vitality ( 4 items), Social functioning (2 items), Role Emotional (3 items), and Mental Health (5 items). The mental health summary measures is called the Mental health component of SF36v. It was used to measure health related quality of life (i.e. mental health). The total score ranged from 0 to 100, a score of 50 is the normative average for general mental health. Lower scores correspond to worse mental health status, higher scores correspond to better mental health status.

Secondary Outcome Measures

Name	Time	Method
Walking Distance	Between Base-line and 24 weeks	Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.
Stair Total (Climb, Descend)	Between Base-line and 24 Weeks	Total amount of stairs climbed and descended for three minutes. Subjects climbed four steps up and descended four steps down. The average change in total number of steps 24 weeks post-baseline was measured.

Trial Locations

Locations (1)

Edward Hines, Jr. VA Hospital; 🇺🇸 Hines, Illinois, United States