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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Diseases, Obesity, Osteoarthritis, Pain

Intervention / Treatment
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* Other: Weight Control Nutritional Program
* Other: Home-based exercise program


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC). | Other: Weight Control Nutritional Program<br>* a week of food diary and information about dietary fat intake and proper proportions of vegetables.<br>* Other names: pole striding walking exercise;Other: Home-based exercise program<br>* 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.<br>|
| Active Comparator: Arm 2<br>Group assigned to a Weight Control Nutritional Program (WC). | Other: Weight Control Nutritional Program<br>* a week of food diary and information about dietary fat intake and proper proportions of vegetables.<br>* Other names: pole striding walking exercise;|
| Active Comparator: Arm 3<br>Group assigned to a home-based exercise program (Ex). | Other: Home-based exercise program<br>* 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.<br>|
| No Intervention: Arm 4<br>Usual care and non- specific health information (C). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Function | 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. | Between Base-line and 24 weeks | 
| Physical Scale SF-36v | 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. | Between Base-line and 24 weeks | 
| Mental Scale SF-36v | 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. | Between Base-line and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Distance | Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured. | Between Base-line and 24 weeks | 
| Stair Total (Climb, Descend) | 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. | Between Base-line and 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stair climb, Elderly, Exercise, lean body mass, muscle strength, Nutrition program, Pain control, walking distance, weight loss