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Aerobic Exercise Intervention for Knee Osteoarthritis

This study is ongoing, but not recruiting participants.

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)
ClinicalTrials.gov Identifier: NCT00049816
  Purpose

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


Condition Intervention
Osteoarthritis
Behavioral: Walking exercise
Behavioral: Cycling Exercise

MedlinePlus related topics:   Exercise and Physical Fitness    Osteoarthritis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Aerobic Exercise Intervention for Knee Osteoarthritis

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Change in consumption of analgesics, reflecting the level of joint pain [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment:   306
Study Start Date:   October 2002
Estimated Study Completion Date:   April 2008
Primary Completion Date:   April 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: No Intervention
Participants will receive no intervention and will act as the control group.
2: Experimental
Participants will partake in a walking exercise program.
Behavioral: Walking exercise
30 minutes/day, 3 times/week for 52 weeks
3: Experimental
Participants will partake in a cycling exercise program.
Behavioral: Cycling Exercise
30 minutes/day, 3 times/week for 52 weeks

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
Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049816

Locations
United States, Minnesota
Mayo Clinic    
      Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Investigators
Principal Investigator:     Kenton R Kaufman, PhD     Mayo Clinic    
  More Information


Publications:

Responsible Party:   Mayo Clinic ( Kenton R. Kaufman )
Study ID Numbers:   R01 AR48768, NIAMS-081
First Received:   November 14, 2002
Last Updated:   December 21, 2007
ClinicalTrials.gov Identifier:   NCT00049816
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
knee  
aerobic exercise  
walking  
cycling
gait
MRI

Study placed in the following topic categories:
Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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