Completed

The Impact of Weight Loss and Exercise on Knee Osteoarthritis

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What is being tested

Behavioral weight control and lifestyle exercise

Behavioral
Who is being recruted

Arthritis+8

+ Body Weight

+ Body Weight Changes

Over 19 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2002
See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2002

Actual date on which the first participant was enrolled.

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.

Official TitleThe Impact of Weight Loss and Exercise on Knee Osteoarthritis
NCT00061490
Principal SponsorJohns Hopkins University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBody WeightBody Weight ChangesJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossOsteoarthritis, Knee

Criteria

5 inclusion criteria required to participate
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

Show More Criteria

9 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
16 weekly educational meetings

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Johns Hopkins Bayview Medical Center

Baltimore, United StatesOpen Johns Hopkins Bayview Medical Center in Google Maps
CompletedOne Study Center