Aerobic Exercise Intervention for Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2007-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Participants will partake in a walking exercise program.

Group Type EXPERIMENTAL

Walking exercise

Intervention Type BEHAVIORAL

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

3

Participants will partake in a cycling exercise program.

Group Type EXPERIMENTAL

Cycling Exercise

Intervention Type BEHAVIORAL

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

Interventions

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Walking exercise

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

Intervention Type BEHAVIORAL

Cycling Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No