Clinical Trial: Aerobic Exercise Intervention for Knee Osteoarthritis


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Sponsored by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Condition	Treatment or Intervention
Osteoarthritis	Behavior: Walking exercise Behavior: Cycling Exercise

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

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.

Inclusion Criteria

Current symptoms of chronic (6-month), 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 (>= 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 > Grade I
Knee flexion contracture > 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 > 24