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Aerobic Exercise Intervention for Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking exercise
Cycling Exercise
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring knee, aerobic exercise, walking, cycling, gait, MRI

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Participants will receive no intervention and will act as the control group.

Participants will partake in a walking exercise program.

Participants will partake in a cycling exercise program.

Outcomes

Primary Outcome Measures

VAS, SF-36, WOMAC, and Activity Index questionnaires
Weight-bearing anterior-posterior (AP) and lateral x-rays of the knee
MRI imaging of the knee
Measurements of gait during level walking and stair climbing

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2002
Last Updated
May 16, 2013
Sponsor
Mayo Clinic
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00049816
Brief Title
Aerobic Exercise Intervention for Knee Osteoarthritis
Official Title
Aerobic Exercise Intervention for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
knee, aerobic exercise, walking, cycling, gait, MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Participants will receive no intervention and will act as the control group.
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will partake in a walking exercise program.
Arm Title
3
Arm Type
Experimental
Arm Description
Participants will partake in a cycling exercise program.
Intervention Type
Behavioral
Intervention Name(s)
Walking exercise
Intervention Description
30 minutes/day, 3 times/week for 52 weeks
Intervention Type
Behavioral
Intervention Name(s)
Cycling Exercise
Intervention Description
30 minutes/day, 3 times/week for 52 weeks
Primary Outcome Measure Information:
Title
VAS, SF-36, WOMAC, and Activity Index questionnaires
Time Frame
Week 52
Title
Weight-bearing anterior-posterior (AP) and lateral x-rays of the knee
Time Frame
Week 52
Title
MRI imaging of the knee
Time Frame
Week 52
Title
Measurements of gait during level walking and stair climbing
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Change in consumption of analgesics, reflecting the level of joint pain
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenton R Kaufman, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15915340
Citation
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.
Results Reference
background
PubMed Identifier
16021447
Citation
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.
Results Reference
background
PubMed Identifier
16949313
Citation
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.
Results Reference
background
PubMed Identifier
17242952
Citation
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.
Results Reference
background
PubMed Identifier
18762657
Citation
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.
Results Reference
result
PubMed Identifier
18461323
Citation
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.
Results Reference
result
PubMed Identifier
18467063
Citation
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.
Results Reference
result

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Aerobic Exercise Intervention for Knee Osteoarthritis

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