Clinical trial NCT00049816: Aerobic Exercise Intervention for Knee Osteoarthritis
Official title: Aerobic Exercise Intervention for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: knee
aerobic exercise
walking
cycling
gait
MRI
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2002-11-15
Enrollment: 306
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will test if walking or bicycling exercise is effective as a non-surgical treatment option for patients with knee osteoarthritis.

Detailed description: 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 criteria: 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

Primary outcomes:
measure: VAS, SF-36, WOMAC, and Activity Index questionnaires
timeFrame: Week 52
measure: Weight-bearing anterior-posterior (AP) and lateral x-rays of the knee
timeFrame: Week 52
measure: MRI imaging of the knee
timeFrame: Week 52
measure: Measurements of gait during level walking and stair climbing
timeFrame: Week 52
Secondary outcomes:
measure: Change in consumption of analgesics, reflecting the level of joint pain
timeFrame: Week 52
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kenton R Kaufman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.