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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2008-12-31

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.

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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.

Conditions

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Chronic Diseases Obesity Osteoarthritis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm 1

Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).

Group Type ACTIVE_COMPARATOR

Weight Control Nutritional Program

Intervention Type OTHER

a week of food diary and information about dietary fat intake and proper proportions of vegetables.

Home-based exercise program

Intervention Type OTHER

24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.

Arm 2

Group assigned to a Weight Control Nutritional Program (WC).

Group Type ACTIVE_COMPARATOR

Weight Control Nutritional Program

Intervention Type OTHER

a week of food diary and information about dietary fat intake and proper proportions of vegetables.

Arm 3

Group assigned to a home-based exercise program (Ex).

Group Type ACTIVE_COMPARATOR

Home-based exercise program

Intervention Type OTHER

24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.

Arm 4

Usual care and non- specific health information (C).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Weight Control Nutritional Program

a week of food diary and information about dietary fat intake and proper proportions of vegetables.

Intervention Type OTHER

Home-based exercise program

24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.

Intervention Type OTHER

Other Intervention Names

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pole striding walking exercise

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No