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Completed

NCT Number: NCT00049816

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking exercise

Behavioral

30 minutes/day, 3 times/week for 52 weeks

Cycling exercise

Behavioral

30 minutes/day, 3 times/week for 52 weeks

Primary outcomes

  1. VAS, SF-36, WOMAC, and Activity Index questionnaires

    Time frame: Week 52

  2. Weight-bearing anterior-posterior (AP) and lateral x-rays of the knee

    Time frame: Week 52

  3. MRI imaging of the knee

    Time frame: Week 52

  4. Measurements of gait during level walking and stair climbing

    Time frame: Week 52

Secondary outcomes

  1. Change in consumption of analgesics, reflecting the level of joint pain

    Time frame: Week 52

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Nov 15, 2002
Registry last updated
May 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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