Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
110 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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