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Search / Trial NCT00381290

Intensive Diet and Exercise for Improving Knee Osteoarthritis in Obese and Overweight Older Adults

Launched by WAKE FOREST UNIVERSITY · Sep 25, 2006

Trial Information

Current as of May 22, 2025

Completed

Keywords

Arthritis Arthritis, Degenerative Knee Health Obesity Overweight Osteoarthritis Weight Loss Diet Exercise Knee Pain

ClinConnect Summary

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 joint structure, including cartilage, neighboring bone, and ligaments. Such structural changes to the knee alter joint function during movement, resulting in pain. The pain typically leads to less physical activity, leading to weight gain, followed by impaired physical function and disability.

Excessive body weight adds to the compressive forces on the knee joint and is a risk factor for OA. ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About Wake Forest University

Wake Forest University is a leading academic institution known for its commitment to innovative research and excellence in education. The university's clinical trial sponsor arm focuses on advancing medical knowledge and improving patient care through rigorous clinical investigations. With a multidisciplinary team of experienced researchers and healthcare professionals, Wake Forest University engages in a wide range of clinical studies that span various therapeutic areas. The institution emphasizes ethical practices, participant safety, and collaboration with industry and regulatory bodies to ensure the integrity and success of its clinical trials. Through its robust research infrastructure, Wake Forest University aims to translate scientific discoveries into effective clinical solutions, ultimately enhancing health outcomes for diverse populations.

Locations

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Stephen P. Messier, PhD

Principal Investigator

Wake Forest University, Department of Health and Exercise Science

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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