The Effect of Weight Loss and Exercise on Knee Osteoarthritis
|Osteoarthritis, Knee||Behavioral: Behavioral weight control and lifestyle exercise|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||The Impact of Weight Loss and Exercise on Knee Osteoarthritis|
- Pain [ Time Frame: 4 months and 16 months ]
|Study Start Date:||September 2002|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
16 weekly educational meetings
Behavioral: Behavioral weight control and lifestyle exercise
16 weekly educational meetings vs. waitlist control
No Intervention: 2
Wait list control
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061490
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Susan J. Bartlett, MD||Johns Hopkins University|