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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR048768 | U.S. NIH Grant/Contract | View source | |
| NIAMS-081 |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
This trial will test if walking or bicycling exercise is effective as a non-surgical treatment option for patients with knee osteoarthritis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Participants will receive no intervention and will act as the control group. | |
| 2 | Experimental | Participants will partake in a walking exercise program. |
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| 3 | Experimental | Participants will partake in a cycling exercise program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking exercise | Behavioral | 30 minutes/day, 3 times/week for 52 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| VAS, SF-36, WOMAC, and Activity Index questionnaires | Week 52 | |
| Weight-bearing anterior-posterior (AP) and lateral x-rays of the knee | Week 52 | |
| MRI imaging of the knee | Week 52 | |
| Measurements of gait during level walking and stair climbing | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in consumption of analgesics, reflecting the level of joint pain | Week 52 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kenton R Kaufman, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15915340 | Background | Schmidt JE, Amrami KK, Manduca A, Kaufman KR. Semi-automated digital image analysis of joint space width in knee radiographs. Skeletal Radiol. 2005 Oct;34(10):639-43. doi: 10.1007/s00256-005-0908-9. Epub 2005 May 25. | |
| 16021447 | Background | Grochowski SJ, Amrami KK, Kaufman K. Semi-automated digital image analysis of patellofemoral joint space width from lateral knee radiographs. Skeletal Radiol. 2005 Oct;34(10):644-8. doi: 10.1007/s00256-005-0944-5. Epub 2005 Jul 15. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Cycling Exercise |
| Behavioral |
30 minutes/day, 3 times/week for 52 weeks |
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| 16949313 | Background | Koff MF, Amrami KK, Kaufman KR. Clinical evaluation of T2 values of patellar cartilage in patients with osteoarthritis. Osteoarthritis Cartilage. 2007 Feb;15(2):198-204. doi: 10.1016/j.joca.2006.07.007. Epub 2006 Sep 1. |
| 17242952 | Background | Agnesi F, Amrami KK, Frigo CA, Kaufman KR. Semiautomated digital analysis of knee joint space width using MR images. Skeletal Radiol. 2007 May;36(5):437-44. doi: 10.1007/s00256-006-0245-7. Epub 2007 Jan 23. |
| 18762657 | Result | Khan FA, Koff MF, Noiseux NO, Bernhardt KA, O'Byrne MM, Larson DR, Amrami KK, Kaufman KR. Effect of local alignment on compartmental patterns of knee osteoarthritis. J Bone Joint Surg Am. 2008 Sep;90(9):1961-9. doi: 10.2106/JBJS.G.00633. |
| 18461323 | Result | Agnesi F, Amrami KK, Frigo CA, Kaufman KR. Comparison of cartilage thickness with radiologic grade of knee osteoarthritis. Skeletal Radiol. 2008 Jul;37(7):639-43. doi: 10.1007/s00256-008-0483-y. Epub 2008 May 7. |
| 18467063 | Result | Koff MF, Amrami KK, Felmlee JP, Kaufman KR. Bias of cartilage T2 values related to method of calculation. Magn Reson Imaging. 2008 Nov;26(9):1236-43. doi: 10.1016/j.mri.2008.03.002. Epub 2008 May 7. |