Clinical Trial: Aerobic Exercise Intervention for Knee Osteoarthritis

This study is currently recruiting patients.

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)

Purpose

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

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

MedlinePlus related topics:  Osteoarthritis

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

Further Study Details: 

Expected Total Enrollment:  306

Study start: October 2002;  Expected completion: September 2006

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 above,  Genders Eligible for Study:  Both

Criteria

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

Location and Contact Information

Kenton R. Kaufman, PhD, PE      507-284-2262 
Kathie Bernhardt      507-266-0985 

Minnesota
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States; Recruiting

More Information

Study ID Numbers:  NIAMS-081; R01 AR48768
Record last reviewed:  March 2005
Last Updated:  March 24, 2005
Record first received:  November 14, 2002
ClinicalTrials.gov Identifier:  NCT00049816
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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