Clinical Trial: Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly with Osteoarthritis of the Knee

This study is no longer recruiting patients.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00126737

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.
Condition Intervention
Osteoarthritis
Obesity
Pain
Chronic Diseases
 Procedure: Weight Control Nutritional Program

MedlinePlus related topics:  Obesity;   Osteoarthritis;   Pain

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: Less pain (as measured by the Western Ontario and McMaster Universities [WOMAC] Osteoarthritis Index)
Secondary Outcomes: Improved physical function (measured by the Functional Performance Inventory); Improved capacity to perform stair climbing and descending; Improved strength; Increased lean body mass; Increase in physical activity at home (measured by pedometer step count)
Expected Total Enrollment:  140

Study start: October 2002;  Study completion: September 2005
Last follow-up: September 2005;  Data entry closure: September 2005

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 Manova statistical method will be applied for data analyses.

Eligibility

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both
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 ACR OA criteria
  • Unable to engage in exercise or follow instruction
  • Limited shoulder range of motion

Location Information


Illinois
      Edward Hines, Jr., Hines,  Illinois,  60141,  United States

Study chairs or principal investigators

Elly Budiman-Mak,  Principal Investigator,  VA Hospital, Hines, IL   

More Information

Study ID Numbers:  E2920R
Last Updated:  August 19, 2005
Record first received:  August 2, 2005
ClinicalTrials.gov Identifier:  NCT00126737
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23

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