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Hines, Illinois 60141


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00126737


Primary Contact:

Principal Investigator
Elly Budiman-Mak, MS MPH MD
Edward Hines Jr. VA Hospital


Backup Contact:

N/A


Location Contact:

Hines, Illinois 60141
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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