We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Aerobic Exercise Intervention for Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00049816
Recruitment Status : Completed
First Posted : November 15, 2002
Last Update Posted : May 17, 2013
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:
Mayo Clinic

November 14, 2002
November 15, 2002
May 17, 2013
October 2002
April 2007   (Final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00049816 on ClinicalTrials.gov Archive Site
Change in consumption of analgesics, reflecting the level of joint pain [ Time Frame: Week 52 ]
Not Provided
Not Provided
Not Provided
Aerobic Exercise Intervention for Knee Osteoarthritis
Aerobic Exercise Intervention for Knee Osteoarthritis
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.

Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Behavioral: Walking exercise
    30 minutes/day, 3 times/week for 52 weeks
  • Behavioral: Cycling Exercise
    30 minutes/day, 3 times/week for 52 weeks
  • No Intervention: 1
    Participants will receive no intervention and will act as the control group.
  • Experimental: 2
    Participants will partake in a walking exercise program.
    Intervention: Behavioral: Walking exercise
  • Experimental: 3
    Participants will partake in a cycling exercise program.
    Intervention: Behavioral: Cycling Exercise

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2007
April 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01AR048768( U.S. NIH Grant/Contract )
R01AR048768 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Kenton R. Kaufman, Mayo Clinic
Mayo Clinic
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Kenton R Kaufman, PhD Mayo Clinic
Mayo Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP