Clinical trial NCT00979043: The Arthritis, Diet, and Activity Promotion Trial
Official title: The Arthritis, Diet, and Activity Promotion Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
weight-loss
exercise
obesity
physical function
total mortality
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2009-09-17
Enrollment: 318
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: self-reported physical function (WOMAC scale)
timeFrame: baseline, 6-months, 18-months
Secondary outcomes:
measure: 6-minute walking distance
timeFrame: baseline, 6-months, 18-months
measure: timed stair climbing
timeFrame: baseline, 6-months, 18-months
measure: weight-loss
timeFrame: baseline, 6-months, 18-months
measure: self-reported pain
timeFrame: baseline, 6-months, 18-months
measure: progression of knee osteoarthritis, measured radiographically
timeFrame: baseline, 6-months, 18-months
measure: chronic inflammation, measured according to CRP, IL-6, IL-6 soluble receptor, TNF-alpha, TNF alpha receptors 1 and 2
timeFrame: baseline and 18-months
measure: total mortality
timeFrame: 7-9 yrs post-trial
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Stephen P Messier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. Arthritis Rheum. 2004 May;50(5):1501-10. doi: 10.1002/art.20256.
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):544-51. doi: 10.1093/ajcn/79.4.544.
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(11):1383-90. doi: 10.1038/sj.ijo.0802737.
citation: 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: 10.1016/j.joca.2008.02.002. Epub 2008 Mar 24.