Aerobic Exercise Intervention for Knee Osteoarthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

November 14, 2002

Last Updated Date

November 25, 2008

Start Date ^ICMJE

October 2002

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00049816 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Aerobic Exercise Intervention for Knee Osteoarthritis

Official Title ^ICMJE

Aerobic Exercise Intervention for Knee Osteoarthritis

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Behavioral: Walking exercise
Behavioral: Cycling Exercise

Study Arms / Comparison Groups

No Intervention: Participants will receive no intervention and will act as the control group.
Experimental: Participants will partake in a walking exercise program.
Experimental: Participants will partake in a cycling exercise program.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

306

Completion Date

April 2007

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00049816

Responsible Party

Kenton R. Kaufman, Mayo Clinic

Study ID Numbers ^ICMJE

R01 AR48768, NIAMS-081

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kenton R Kaufman, PhD

Mayo Clinic

Information Provided By

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

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP