NCT00979043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 1997

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1997

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
Last Updated

April 14, 2023

Status Verified

July 1, 2018

Enrollment Period

3.1 years

First QC Date

September 16, 2009

Last Update Submit

April 12, 2023

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritisweight-lossexerciseobesityphysical functiontotal mortality

Outcome Measures

Primary Outcomes (1)

  • self-reported physical function (WOMAC scale)

    baseline, 6-months, 18-months

Secondary Outcomes (7)

  • 6-minute walking distance

    baseline, 6-months, 18-months

  • timed stair climbing

    baseline, 6-months, 18-months

  • weight-loss

    baseline, 6-months, 18-months

  • self-reported pain

    baseline, 6-months, 18-months

  • progression of knee osteoarthritis, measured radiographically

    baseline, 6-months, 18-months

  • +2 more secondary outcomes

Study Arms (4)

Dietary weight-loss

ACTIVE COMPARATOR

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.

Behavioral: Dietary Weight-loss

Exercise

ACTIVE COMPARATOR

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.

Behavioral: Exercise

Dietary weight-loss & exercise

ACTIVE COMPARATOR

Participants received both the dietary weight-loss and exercise interventions for 18-months

Behavioral: Dietary Weight-lossBehavioral: Exercise

Health lifestyle control

NO INTERVENTION

The healthy-lifestyle control served as the usual care comparison group. For 3 months, participants met monthly with a health educator to discuss topics such as osteoarthritis, obesity, and exercise. Regular phone contact was maintained during months 4-18.

Interventions

Dietary Weight-lossBEHAVIORAL

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-lossDietary weight-loss & exercise
ExerciseBEHAVIORAL

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.

Dietary weight-loss & exerciseExercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (4)

  • 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.

    PMID: 15146420RESULT

  • 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.

    PMID: 15051595RESULT

  • 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.

    PMID: 15278105RESULT

  • 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.

    PMID: 18359648RESULT

MeSH Terms

Conditions

Osteoarthritis, KneeWeight LossMotor ActivityObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stephen P Messier, PhD

    Wake Forest University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 17, 2009

Study Start

November 1, 1997

Primary Completion

December 1, 2000

Study Completion

December 1, 2000

Last Updated

April 14, 2023

Record last verified: 2018-07

Locations

US(1)