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Clinical Trials/NCT00061490
NCT00061490
Completed
Not Applicable

The Impact of Weight Loss and Exercise on Knee Osteoarthritis

Johns Hopkins University1 site in 1 country160 target enrollmentSeptember 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Johns Hopkins University
Enrollment
160
Locations
1
Primary Endpoint
Pain
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study will evaluate whether a program of weight loss and exercise can help individuals with knee osteoarthritis (OA).

Detailed Description

Knee OA is a major public health challenge affecting millions of people in the United States. Obesity is a primary target for intervention since it accounts for up to 30% of knee OA, exacerbates symptoms, and is associated with bilateral involvement and more rapid progression of the disease. While the American College of Rheumatology (ACR) Practice Guidelines recommend modest weight loss as symptomatic therapy, no published clinical trials have investigated the impact of weight loss on knee OA. Physical activity has also been associated with pain reduction and increased mobility in individuals with knee OA and the ACR Practice Guidelines indicate that it should be included in treatment. Exercise may be especially helpful for overweight persons with knee OA as it is a potent predictor of weight loss maintenance. Though adherence to traditional exercise programs has been poor, adopting lifestyles in which exercise is accumulated throughout the day appears to be a promising new approach to physical activity. Lifestyle exercise may enhance exercise adherence by increasing options to be active and reducing time barriers. Episodic physical activity may also be preferable to continuous exercise by reducing pain and avoiding injury. The primary objective of this proposal is to evaluate the impact of weight loss and lifestyle exercise on knee osteoarthritis. Participants will be randomly assigned to either a behavioral weight loss and exercise program or a delayed intervention group. Participants in the behavioral weight loss and exercise group will attend weekly group meetings at the Johns Hopkins Bayview Medical Center for 16 weeks. Group meetings last about 1 hour and are led by health care professionals. Participants will be taught how to lose weight and keep weight off by changing what they eat and evaluating their lifestyle. Participants will be instructed on a safe and effective diet plan (1200 calories/day for women; 1500 calories/day for men) and will be asked to increase their physical activity to about 30 minutes per day of brisk walking, most days of the week. After the 16-week program, groups will continue to meet every three months for 1 year to help sustain lifestyle changes. The delayed intervention group will receive the program described above after a 4-month waiting period. The primary outcome measure will be knee pain. Secondary measures include physical disability, quality of life, performance measures, and long-term adherence to behavior change.

Registry
clinicaltrials.gov
Start Date
September 2002
End Date
April 2006
Last Updated
8 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Pain

Time Frame: 4 months and 16 months

Study Sites (1)

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