Status:
COMPLETED
Intensive Diet and Exercise for Improving Knee Osteoarthritis in Obese and Overweight Older Adults
Lead Sponsor:
Wake Forest University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
General Nutrition Center, Inc
Conditions:
Osteoarthritis
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the effects of a calorie-restricting diet, exercise, and a combination of both in reducing knee inflammation and compressive forces in obese and overweight adul...
Detailed Description
OA, the most common form of arthritis, occurs in about 21 million Americans. Of all the weight-bearing joints, the knee is most commonly affected by OA. Knee OA leads to physical changes to the entire...
Eligibility Criteria
Inclusion
- Grade II to III radiographic tibiofemoral OA of one or both knees
- Body mass index (BMI) of 27 to 37
- Sedentary lifestyle, defined as not participating in more than 30 minutes of formal exercise per week within the 6 months prior to study entry
Exclusion
- Significant comorbidity that may pose a safety risk to the participant or otherwise interfere with the study. More information about this criterion can be found in the protocol.
- Previous acute knee injury
- Knee injection within 1 month of study entry
- Knee surgery within 6 months of study entry
- Knee OA other than tibiofemoral OA
- Unwilling or unable to change eating and physical activity habits due to environment
- Cannot speak or read English
- Excess alcohol use (21 or more drinks per week)
- Unable to finish the 18-month study or unlikely to comply with the study
- Unable to undergo MRI of the knee
- Significant cognitive impairment
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT00381290
Start Date
October 1 2006
End Date
June 1 2011
Last Update
November 6 2017
Active Locations (1)
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1
Wake Forest University/Wake Forest University Forest School of Medicine
Winston-Salem, North Carolina, United States, 27109