Aerobic Exercise Intervention for Knee Osteoarthritis
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| ClinicalTrials.gov Identifier: NCT00049816 |
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Recruitment Status :
Completed
First Posted : November 15, 2002
Last Update Posted : May 17, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis | Behavioral: Walking exercise Behavioral: Cycling Exercise | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 306 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Aerobic Exercise Intervention for Knee Osteoarthritis |
| Study Start Date : | October 2002 |
| Actual Primary Completion Date : | April 2007 |
| Actual Study Completion Date : | April 2007 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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.
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Behavioral: Cycling Exercise
30 minutes/day, 3 times/week for 52 weeks |
- VAS, SF-36, WOMAC, and Activity Index questionnaires [ Time Frame: Week 52 ]
- Weight-bearing anterior-posterior (AP) and lateral x-rays of the knee [ Time Frame: Week 52 ]
- MRI imaging of the knee [ Time Frame: Week 52 ]
- Measurements of gait during level walking and stair climbing [ Time Frame: Week 52 ]
- Change in consumption of analgesics, reflecting the level of joint pain [ Time Frame: Week 52 ]
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| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Current symptoms of chronic (6 months), stable pain and/or stiffness in one or both knees during weight-bearing activities
- Involved joint is primary factor limiting physical or functional activity
- Radiographic signs of mild or moderate arthritis
- Mild joint space narrowing (at least 2mm remaining)
Exclusion Criteria
- Current participation in a regular exercise program
- Existing medical condition that would preclude increased physical activity
- Subjective complaint of instability (giving way)
- Ligamentous instability greater than Grade I
- Knee flexion contracture greater than 15 degrees
- Asymptomatic osteoarthritis of both knees, incapacitating arthritis, or inflammatory arthritis
- Major reconstructive surgery on a lower extremity joint
- Multiple major joint involvement
- Any condition which severely limits local ambulation, such as amputation or stroke
- Gait aids used majority of time for ambulation
- Cannot use step-over-step techniques in either ascending or descending stair conditions
- Not able to undergo MRI scan (e.g., cardiac pacemaker)
- Dementia or inability to give informed consent as determined by a Folstein Mini Mental score greater than 24
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): NCT00049816
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Kenton R Kaufman, PhD | Mayo Clinic |
Publications of Results:
Other Publications:
| Responsible Party: | Kenton R. Kaufman, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00049816 History of Changes |
| Other Study ID Numbers: |
R01AR048768 ( U.S. NIH Grant/Contract ) R01AR048768 ( U.S. NIH Grant/Contract ) NIAMS-081 |
| First Posted: | November 15, 2002 Key Record Dates |
| Last Update Posted: | May 17, 2013 |
| Last Verified: | May 2013 |
Keywords provided by Mayo Clinic:
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knee aerobic exercise walking |
cycling gait MRI |
Additional relevant MeSH terms:
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Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |