The Effect of Weight Loss and Exercise on Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00061490
First received: May 28, 2003
Last updated: February 29, 2008
Last verified: February 2008
  Purpose

This study will evaluate whether a program of weight loss and exercise can help individuals with knee osteoarthritis (OA).


Condition Intervention
Osteoarthritis, Knee
Behavioral: Behavioral weight control and lifestyle exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Weight Loss and Exercise on Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Pain [ Time Frame: 4 months and 16 months ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: September 2002
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
16 weekly educational meetings
Behavioral: Behavioral weight control and lifestyle exercise
16 weekly educational meetings vs. waitlist control
No Intervention: 2
Wait list control

Detailed Description:

Knee OA is a major public health challenge affecting millions of people in the United States. Obesity is a primary target for intervention since it accounts for up to 30% of knee OA, exacerbates symptoms, and is associated with bilateral involvement and more rapid progression of the disease. While the American College of Rheumatology (ACR) Practice Guidelines recommend modest weight loss as symptomatic therapy, no published clinical trials have investigated the impact of weight loss on knee OA.

Physical activity has also been associated with pain reduction and increased mobility in individuals with knee OA and the ACR Practice Guidelines indicate that it should be included in treatment. Exercise may be especially helpful for overweight persons with knee OA as it is a potent predictor of weight loss maintenance. Though adherence to traditional exercise programs has been poor, adopting lifestyles in which exercise is accumulated throughout the day appears to be a promising new approach to physical activity. Lifestyle exercise may enhance exercise adherence by increasing options to be active and reducing time barriers. Episodic physical activity may also be preferable to continuous exercise by reducing pain and avoiding injury. The primary objective of this proposal is to evaluate the impact of weight loss and lifestyle exercise on knee osteoarthritis.

Participants will be randomly assigned to either a behavioral weight loss and exercise program or a delayed intervention group. Participants in the behavioral weight loss and exercise group will attend weekly group meetings at the Johns Hopkins Bayview Medical Center for 16 weeks. Group meetings last about 1 hour and are led by health care professionals. Participants will be taught how to lose weight and keep weight off by changing what they eat and evaluating their lifestyle. Participants will be instructed on a safe and effective diet plan (1200 calories/day for women; 1500 calories/day for men) and will be asked to increase their physical activity to about 30 minutes per day of brisk walking, most days of the week. After the 16-week program, groups will continue to meet every three months for 1 year to help sustain lifestyle changes.

The delayed intervention group will receive the program described above after a 4-month waiting period.

The primary outcome measure will be knee pain. Secondary measures include physical disability, quality of life, performance measures, and long-term adherence to behavior change.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Knee arthritis
  • Pain on > 50 % of days in the month in one or both knees
  • Difficulty with activities of daily living due to knee pain
  • X-ray documenting knee OA within 1 year prior to study entry
  • 15 lbs to 50 lbs overweight

Exclusion Criteria

  • Significant cardiac, pulmonary, renal, or hepatic disease
  • Major psychiatric disease
  • ACR functional class IV
  • Structured exercise more than once per week for 20 minutes or longer during the 3 months prior to study entry
  • Anticipates moving from the area within 18 months of study entry
  • Anticipates undergoing knee surgery within 1 year of study entry
  • Weight loss of more than 5 kg (11 lbs) in 3 months prior to study entry
  • Anorexiant or other medications known to affect metabolism
  • Current or planned pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061490

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Investigators
Principal Investigator: Susan J. Bartlett, MD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Susan Bartlett, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00061490     History of Changes
Other Study ID Numbers: K23 AR002160, NIAMS-080
Study First Received: May 28, 2003
Last Updated: February 29, 2008
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Osteoarthritis
Arthritis
Weight Loss

Additional relevant MeSH terms:
Osteoarthritis
Weight Loss
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014