The Arthritis, Diet, and Activity Promotion Trial

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Behavioral: Dietary Weight-loss; Behavioral: Exercise

• Registration Number: NCT00979043
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-11
• Primary Completion: 2000-12
• Study Completion: 2000-12
• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Status Verified: 2018-07
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary weight-loss & exercise	Exercise	Participants received both the dietary weight-loss and exercise interventions for 18-months
Dietary weight-loss	Dietary Weight-loss	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.
Dietary weight-loss & exercise	Dietary Weight-loss	Participants received both the dietary weight-loss and exercise interventions for 18-months
Exercise	Exercise	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 Outcome Measures

Name	Time	Method
self-reported physical function (WOMAC scale)	baseline, 6-months, 18-months

Secondary Outcome Measures

Name	Time	Method
self-reported pain	baseline, 6-months, 18-months
weight-loss	baseline, 6-months, 18-months
timed stair climbing	baseline, 6-months, 18-months
progression of knee osteoarthritis, measured radiographically	baseline, 6-months, 18-months
6-minute walking distance	baseline, 6-months, 18-months
chronic inflammation, measured according to CRP, IL-6, IL-6 soluble receptor, TNF-alpha, TNF alpha receptors 1 and 2	baseline and 18-months
total mortality	7-9 yrs post-trial

Trial Locations

Locations (1)

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States