Osteoarthritis, Knee Clinical Trial
Official title:
The Impact of Weight Loss and Exercise on Knee Osteoarthritis
This study will evaluate whether a program of weight loss and exercise can help individuals with knee osteoarthritis (OA).
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.
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