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CompletedNCT00049816Updated May 17, 2013

Aerobic Exercise Intervention for Knee Osteoarthritis

An interventional study of Walking exercise and Cycling Exercise in Osteoarthritis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2013-05-17.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
306
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Osteoarthritis

Keywords

  • knee
  • aerobic exercise
  • walking
  • cycling
  • gait
  • MRI
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In context

Osteoarthritis

4,397 studies on the registry are indexed under Osteoarthritis; 581 are open to participants now.

This study's enrollment of 306 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
306 participants (actual)

Study arms

  • 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.

    Behavioral: Walking exercise

  • Experimental
    3

    Participants will partake in a cycling exercise program.

    Behavioral: Cycling Exercise

Interventions

  • BehavioralWalking exercise

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

  • BehavioralCycling Exercise

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

06

What researchers measure

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

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Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

Publications

  • Schmidt JE, Amrami KK, Manduca A, Kaufman KR. Semi-automated digital image analysis of joint space width in knee radiographs. Skeletal Radiol. 2005 Oct;34(10):639-43. doi: 10.1007/s00256-005-0908-9. Epub 2005 May 25. PubMed 15915340 ↗
  • Grochowski SJ, Amrami KK, Kaufman K. Semi-automated digital image analysis of patellofemoral joint space width from lateral knee radiographs. Skeletal Radiol. 2005 Oct;34(10):644-8. doi: 10.1007/s00256-005-0944-5. Epub 2005 Jul 15. PubMed 16021447 ↗
  • Koff MF, Amrami KK, Kaufman KR. Clinical evaluation of T2 values of patellar cartilage in patients with osteoarthritis. Osteoarthritis Cartilage. 2007 Feb;15(2):198-204. doi: 10.1016/j.joca.2006.07.007. Epub 2006 Sep 1. PubMed 16949313 ↗
  • Agnesi F, Amrami KK, Frigo CA, Kaufman KR. Semiautomated digital analysis of knee joint space width using MR images. Skeletal Radiol. 2007 May;36(5):437-44. doi: 10.1007/s00256-006-0245-7. Epub 2007 Jan 23. PubMed 17242952 ↗
  • Khan FA, Koff MF, Noiseux NO, Bernhardt KA, O'Byrne MM, Larson DR, Amrami KK, Kaufman KR. Effect of local alignment on compartmental patterns of knee osteoarthritis. J Bone Joint Surg Am. 2008 Sep;90(9):1961-9. doi: 10.2106/JBJS.G.00633. PubMed 18762657 ↗
  • Agnesi F, Amrami KK, Frigo CA, Kaufman KR. Comparison of cartilage thickness with radiologic grade of knee osteoarthritis. Skeletal Radiol. 2008 Jul;37(7):639-43. doi: 10.1007/s00256-008-0483-y. Epub 2008 May 7. PubMed 18461323 ↗
  • Koff MF, Amrami KK, Felmlee JP, Kaufman KR. Bias of cartilage T2 values related to method of calculation. Magn Reson Imaging. 2008 Nov;26(9):1236-43. doi: 10.1016/j.mri.2008.03.002. Epub 2008 May 7. PubMed 18467063 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00049816
Lead sponsor
Mayo Clinic
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted
Nov 15, 2002
Start date
Oct 2002
Primary completion
Apr 2007
Completion
Apr 2007
Last update
May 17, 2013

Study contacts

Kenton R Kaufman, PhD
principal investigator · Mayo Clinic
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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