Skip to main content
OpenTrials
Completed

NCT Number: NCT00979043

The Arthritis, Diet, and Activity Promotion Trial

The primary purpose of this study was to determine the effect of dietary weight-loss, exercise training, or a combination of both on physical function in overweight and obese adults with knee osteoarthritis (OA). In secondary analyses, the effect of weight-loss and/or exercise on OA progression, self-reported pain and inflammation were examined. In post-trial analyses, the effect of dietary weight-loss on total mortality was determined.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Behavior Body Weight Body Weight Changes Joint Diseases Motor Activity Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoarthritis Osteoarthritis, Knee Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Weight Loss

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 60 years.
  • BMI ≥ 28 kg/m2.
  • Knee pain on most days of the month.
  • Sedentary lifestyle pattern (<20 min exercise per week for last 6 months)
  • Self-reported difficulty with at least one of the following: walking 1/4 mile, climbing stairs, kneeling, bending, stooping, shopping, lifting, self-care.
  • Radiographic evidence of grade 1-3 knee osteoarthritis.

Exclusion criteria

  • Serious medical condition that precludes safe participation in exercise such as heart disease (angina, congestive heart failure), severe hypertension, COPD, renal or liver disease, insulin-dependent diabetes.
  • Mini-mental state exam score <24.
  • Inability to walks without a cane.
  • Reported alcohol consumption >14 drinks/week.
  • Inability to complete protocol.
  • ST segment depression.
  • Participation in another research study.

Treatment and study plan

Dietary Weight-loss

Behavioral

The goal of the dietary weight-loss intervention was to produce and maintain a mean weight-loss of 5% initial body weight during the 18-month intervention, using dietary counseling and behavior modification.

Exercise

Behavioral

Participants participated in resistance training (15 minutes) and aerobic exercise (30 minutes) 3d/week for 18-months. The first 4-months of the exercise training were facility-based. After 4-months, participants were allowed to transition to a home-based intervention if they chose to.

Primary outcomes

  1. self-reported physical function (WOMAC scale)

    Time frame: baseline, 6-months, 18-months

Secondary outcomes

  1. 6-minute walking distance

    Time frame: baseline, 6-months, 18-months

  2. timed stair climbing

    Time frame: baseline, 6-months, 18-months

  3. weight-loss

    Time frame: baseline, 6-months, 18-months

  4. self-reported pain

    Time frame: baseline, 6-months, 18-months

  5. progression of knee osteoarthritis, measured radiographically

    Time frame: baseline, 6-months, 18-months

  6. chronic inflammation, measured according to CRP, IL-6, IL-6 soluble receptor, TNF-alpha, TNF alpha receptors 1 and 2

    Time frame: baseline and 18-months

  7. total mortality

    Time frame: 7-9 yrs post-trial

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: ADAPT

Important dates

Study start
1997
Primary completion
2000
Study completion
2000
First posted
Sep 17, 2009
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.