The Arthritis, Diet, and Activity Promotion Trial

Knee Osteoarthritis Clinical Trial

— ADAPT  

Official title:

The Arthritis, Diet, and Activity Promotion Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979043
• Other study ID #: IRB00003799
• Secondary ID: P60AG010484-07
• Status: Completed
• Phase: N/A
• Start date: November 1997
• Est. completion date: December 2000

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: December 2000
• Est. primary completion date: December 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Chua SD Jr, Messier SP, Legault C, Lenz ME, Thonar EJ, Loeser RF. Effect of an exercise and dietary intervention on serum biomarkers in overweight and obese adults with osteoarthritis of the knee. Osteoarthritis Cartilage. 2008 Sep;16(9):1047-53. doi: 10. — View Citation

Messier SP, Loeser RF, Miller GD, Morgan TM, Rejeski WJ, Sevick MA, Ettinger WH Jr, Pahor M, Williamson JD. Exercise and dietary weight loss in overweight and obese older adults with knee osteoarthritis: the Arthritis, Diet, and Activity Promotion Trial. — View Citation

Miller GD, Nicklas BJ, Davis CC, Ambrosius WT, Loeser RF, Messier SP. Is serum leptin related to physical function and is it modifiable through weight loss and exercise in older adults with knee osteoarthritis? Int J Obes Relat Metab Disord. 2004 Nov;28(1 — View Citation

Nicklas BJ, Ambrosius W, Messier SP, Miller GD, Penninx BW, Loeser RF, Palla S, Bleecker E, Pahor M. Diet-induced weight loss, exercise, and chronic inflammation in older, obese adults: a randomized controlled clinical trial. Am J Clin Nutr. 2004 Apr;79(4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-reported physical function (WOMAC scale)		baseline, 6-months, 18-months
Secondary	6-minute walking distance		baseline, 6-months, 18-months
Secondary	timed stair climbing		baseline, 6-months, 18-months
Secondary	weight-loss		baseline, 6-months, 18-months
Secondary	self-reported pain		baseline, 6-months, 18-months
Secondary	progression of knee osteoarthritis, measured radiographically		baseline, 6-months, 18-months
Secondary	chronic inflammation, measured according to CRP, IL-6, IL-6 soluble receptor, TNF-alpha, TNF alpha receptors 1 and 2		baseline and 18-months
Secondary	total mortality		7-9 yrs post-trial