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| Sponsor: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
|---|---|
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00049816 |
Purpose
This trial will test if walking or bicycling exercise is effective as a non-surgical treatment option for patients with knee osteoarthritis.
| Condition | Intervention |
|---|---|
|
Osteoarthritis |
Behavioral: Walking exercise Behavioral: Cycling Exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Aerobic Exercise Intervention for Knee Osteoarthritis |
| Enrollment: | 306 |
| Study Start Date: | October 2002 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Participants will receive no intervention and will act as the control group.
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Experimental: 2
Participants will partake in a walking exercise program.
|
Behavioral: Walking exercise
30 minutes/day, 3 times/week for 52 weeks
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Experimental: 3
Participants will partake in a cycling exercise program.
|
Behavioral: Cycling Exercise
30 minutes/day, 3 times/week for 52 weeks
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Traditional, conservative medical treatment of osteoarthritis has been directed at improving functional status through reducing joint pain and inflammation and maintaining or restoring joint function. Exercise is an adjunct therapy in the clinical management of patients with osteoarthritis of the knee. However, it is not uniformly accepted. The central hypothesis of this work is that the Surgeon General's exercise guidelines can be successfully implemented as an effective nonsurgical option for treatment of patients with early stages of knee osteoarthritis.
Patients with knee osteoarthritis will be randomized into a control group, a walking exercise group, and a stationary cycling exercise group. The individuals in the exercise groups will be required to exercise three times per week for one year using emerging public health recommendations for aerobic exercise in the adult and aging population. Patient outcome will be assessed using objective gait analysis measurements, knee radiographs to quantify joint space narrowing, magnetic resonance imaging, a general health questionnaire (SF-36), a disease/site specific questionnaire (WOMAC), and a visual-analog pain scale. All subjects will be studied at 0 and 52 weeks.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
More Information
| Responsible Party: | Kenton R. Kaufman, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00049816 History of Changes |
| Other Study ID Numbers: | R01 AR48768, NIAMS-081 |
| Study First Received: | November 14, 2002 |
| Last Updated: | November 25, 2008 |
| Health Authority: | United States: Federal Government |
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knee aerobic exercise walking |
cycling gait MRI |
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Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |