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Aerobic Exercise Intervention for Knee Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00049816
First received: November 14, 2002
Last updated: May 16, 2013
Last verified: May 2013

November 14, 2002
May 16, 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 ] [ Designated as safety issue: No ]
  • Weight-bearing anterior-posterior (AP) and lateral x-rays of the knee [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • MRI imaging of the knee [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Measurements of gait during level walking and stair climbing [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
  • 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.
 
Completed
306
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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00049816
R01 AR48768, R01AR048768, NIAMS-081
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