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The Effect of Weight Loss and Exercise on Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral weight control and lifestyle exercise
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Arthritis, Weight Loss

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

16 weekly educational meetings

Wait list control

Outcomes

Primary Outcome Measures

Pain

Secondary Outcome Measures

Full Information

First Posted
May 28, 2003
Last Updated
September 22, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00061490
Brief Title
The Effect of Weight Loss and Exercise on Knee Osteoarthritis
Official Title
The Impact of Weight Loss and Exercise on Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2002 (Actual)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Arthritis, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
16 weekly educational meetings
Arm Title
2
Arm Type
No Intervention
Arm Description
Wait list control
Intervention Type
Behavioral
Intervention Name(s)
Behavioral weight control and lifestyle exercise
Intervention Description
16 weekly educational meetings vs. waitlist control
Primary Outcome Measure Information:
Title
Pain
Time Frame
4 months and 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J. Bartlett, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Weight Loss and Exercise on Knee Osteoarthritis

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