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The Effect of Weight Loss and Exercise on Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00061490
First Posted: May 29, 2003
Last Update Posted: September 26, 2017
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.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Johns Hopkins University
  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
Intervention Model: Factorial Assignment
Masking: None (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 Johns Hopkins University:

Primary Outcome Measures:
  • Pain [ Time Frame: 4 months and 16 months ]

Enrollment: 160
Actual 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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061490


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Susan J. Bartlett, MD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00061490     History of Changes
Other Study ID Numbers: K23AR002160 ( U.S. NIH Grant/Contract )
NIAMS-080
First Submitted: May 28, 2003
First Posted: May 29, 2003
Last Update Posted: September 26, 2017
Last Verified: September 2017

Keywords provided by Johns Hopkins University:
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