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Intensive Diet and Exercise for Improving Knee Osteoarthritis in Obese and Overweight Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00381290
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
General Nutrition Center, Inc
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date  ICMJE September 25, 2006
First Posted Date  ICMJE September 27, 2006
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE October 2006
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2009)
  • Inflammatory biomarkers [ Time Frame: Measured at 0, 6, and 18 months (analyzed at 18 months) ]
  • Knee joint loads [ Time Frame: Measured at 0, 6, and 18 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2006)
  • Inflammatory biomarkers
  • Knee joint loads
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2009)
  • Bone marrow lesions [ Time Frame: Measured at 0 and 18 months (analyzed at 18 months) ]
  • Articular cartilage [ Time Frame: Measured at 0 and 18 months (analyzed at 18 months) ]
  • Function [ Time Frame: Measured at 0, 6, and 18 months ]
  • Pain [ Time Frame: Measured at 0, 6, and 18 months ]
  • Mobility [ Time Frame: Measured at 0, 6, and 18 months ]
  • Change in quadriceps' strength and disease progression as a function of knee alignment [ Time Frame: Measured at 0, 6, and 18 months (analyzed at 18 months) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2006)
  • Bone marrow lesions
  • Articular cartilage
  • Function
  • Pain
  • Mobility
  • Change in quadriceps' strength and disease progression as a function of knee alignment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intensive Diet and Exercise for Improving Knee Osteoarthritis in Obese and Overweight Older Adults
Official Title  ICMJE Intensive Diet and Exercise for Arthritis
Brief Summary The purpose of this study is to compare the effects of a calorie-restricting diet, exercise, and a combination of both in reducing knee inflammation and compressive forces in obese and overweight adults with knee osteoarthritis (OA).
Detailed Description

OA, the most common form of arthritis, occurs in about 21 million Americans. Of all the weight-bearing joints, the knee is most commonly affected by OA. Knee OA leads to physical changes to the entire joint structure, including cartilage, neighboring bone, and ligaments. Such structural changes to the knee alter joint function during movement, resulting in pain. The pain typically leads to less physical activity, leading to weight gain, followed by impaired physical function and disability.

Excessive body weight adds to the compressive forces on the knee joint and is a risk factor for OA. While there is no cure for OA, weight loss is the best nonpharmacologic way to slow OA progression. The amount of weight loss necessary to alter OA progression is unknown. The purpose of this study is to compare the effects of significant dietary restriction, exercise, and a combination of both in reducing knee inflammation and compressive forces in obese and overweight adults with knee OA. The study will also examine how diet and exercise affect everyday function and pain levels, as well as the extent of weight loss necessary for slowing OA disease progression.

This study will last 18 months. Four, 2-hour screening visits will include various questionnaires, physical exams, physical performance tests, x-rays, and blood and urine collection. Half of the participants will also undergo additional x-rays, magnetic resonance imaging (MRI), and a CT scan. Eligible participants will be randomly assigned to one of three intervention groups:

  • Group 1 participants will follow a calorie-restricted diet
  • Group 2 participants will follow an exercise regimen
  • Group 3 participants will follow a calorie-restricted diet and an exercise regimen

Group 1 and 3 participants will aim to lose at least 10% of their body weight and drop to the next lower body mass index (BMI) class level; Group 2 participants will aim to maintain their weight. Group 1 and 3 participants will follow the prescribed diet, which will include traditional healthy food and up to two meal replacement supplements. Initially, the diet will be set to result in an overall loss of 800 to 1000 calories per day. Body weight will be monitored during weekly nutritional education and behavioral sessions. For the first 6 months, Group 1 and 3 participants will attend one individual session and three group sessions per month. During Months 7 through 18, participants will attend group sessions once every two weeks and individual sessions once every 3 months. Throughout the study, participants will record food and beverage intake in daily logs that will be collected monthly.

Group 2 and 3 participants will partake in three, 60-minute exercise sessions per week for the duration of the study. The exercise sessions will incorporate aerobic exercise and resistance training. Participants will also be encouraged to exercise at home. Body weight will be monitored monthly.

Follow-up evaluations for all participants will occur at Months 6 and 18, during which most of the screening procedures will be repeated. The Month 6 follow-up will include two study visits, and the Month 18 follow-up will include three study visits. Group 2 participants will be offered dietary counseling at the end of the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Behavioral: Diet
    The prescribed diet will include traditional healthy food and up to two meal replacement supplements. Initially, the diet will be set to result in an overall loss of 800 to 1000 calories per day.
  • Behavioral: Exercise
    The program will consist of 60-minute exercise sessions per week for the duration of the study. The exercise sessions will incorporate aerobic exercise and resistance training. Participants will also be encouraged to exercise at home.
Study Arms  ICMJE
  • Active Comparator: 1
    Participants will follow an exercise regimen
    Intervention: Behavioral: Exercise
  • Active Comparator: 2
    Participants will follow a calorie-restricted diet
    Intervention: Behavioral: Diet
  • Active Comparator: 3
    Participants will follow a calorie-restricted diet and an exercise regimen
    Interventions:
    • Behavioral: Diet
    • Behavioral: Exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2011)
454
Original Enrollment  ICMJE
 (submitted: September 25, 2006)
450
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Grade II to III radiographic tibiofemoral OA of one or both knees
  • Body mass index (BMI) of 27 to 37
  • Sedentary lifestyle, defined as not participating in more than 30 minutes of formal exercise per week within the 6 months prior to study entry

Exclusion Criteria:

  • Significant comorbidity that may pose a safety risk to the participant or otherwise interfere with the study. More information about this criterion can be found in the protocol.
  • Previous acute knee injury
  • Knee injection within 1 month of study entry
  • Knee surgery within 6 months of study entry
  • Knee OA other than tibiofemoral OA
  • Unwilling or unable to change eating and physical activity habits due to environment
  • Cannot speak or read English
  • Excess alcohol use (21 or more drinks per week)
  • Unable to finish the 18-month study or unlikely to comply with the study
  • Unable to undergo MRI of the knee
  • Significant cognitive impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00381290
Other Study ID Numbers  ICMJE R01AR052528( U.S. NIH Grant/Contract )
R01AR052528 ( U.S. NIH Grant/Contract )
1R01AR052528-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor  ICMJE Wake Forest University
Collaborators  ICMJE
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • General Nutrition Center, Inc
Investigators  ICMJE
Principal Investigator: Stephen P. Messier, PhD Wake Forest University, Department of Health and Exercise Science
PRS Account Wake Forest University Health Sciences
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP