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

This study has been completed.
Sponsor:
Collaborators:
General Nutrition Center, Inc
Information provided by (Responsible Party):
Stephen Messier, Wake Forest University
ClinicalTrials.gov Identifier:
NCT00381290
First received: September 25, 2006
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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).


Condition Intervention Phase
Osteoarthritis
Behavioral: Diet
Behavioral: Exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensive Diet and Exercise for Arthritis

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Inflammatory biomarkers [ Time Frame: Measured at 0, 6, and 18 months (analyzed at 18 months) ] [ Designated as safety issue: No ]
  • Knee joint loads [ Time Frame: Measured at 0, 6, and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone marrow lesions [ Time Frame: Measured at 0 and 18 months (analyzed at 18 months) ] [ Designated as safety issue: No ]
  • Articular cartilage [ Time Frame: Measured at 0 and 18 months (analyzed at 18 months) ] [ Designated as safety issue: No ]
  • Function [ Time Frame: Measured at 0, 6, and 18 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Measured at 0, 6, and 18 months ] [ Designated as safety issue: No ]
  • Mobility [ Time Frame: Measured at 0, 6, and 18 months ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 454
Study Start Date: October 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will follow an exercise regimen
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.
Active Comparator: 2
Participants will follow a calorie-restricted diet
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.
Active Comparator: 3
Participants will follow a calorie-restricted diet and an exercise regimen
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381290

Locations
United States, North Carolina
Wake Forest University/Wake Forest University Forest School of Medicine
Winston-Salem, North Carolina, United States, 27109
Sponsors and Collaborators
Wake Forest School of Medicine
General Nutrition Center, Inc
Investigators
Principal Investigator: Stephen P. Messier, PhD Wake Forest University, Department of Health and Exercise Science
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stephen Messier, Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT00381290     History of Changes
Other Study ID Numbers: R01 AR052528, R01AR052528, 1R01AR052528-01A2
Study First Received: September 25, 2006
Last Updated: September 14, 2011
Health Authority: United States: Federal Government

Keywords provided by Wake Forest School of Medicine:
Arthritis
Arthritis, Degenerative
Knee Health
Obesity
Overweight
Osteoarthritis
Weight Loss
Diet
Exercise
Knee Pain

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014