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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00427843
Other study ID # REH-324-06
Secondary ID
Status Completed
Phase N/A
First received January 25, 2007
Last updated October 14, 2008
Start date January 2007
Est. completion date September 2008

Study information

Verified date October 2008
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the influence of a home program of exercises for the hip muscles which support the pelvis on walking patterns and hip muscle strength in people with knee osteoarthritis. Following a hip muscle strengthening program, we hypothesize that participants with knee osteoarthritis will demonstrate decreased loading at the knee joint during walking and greater strength of the hip muscles.


Description:

Knee osteoarthritis is a common age-related impairment that may progress to cause significant pain and physical disability. Excessive loading at the knee joint is believed to contribute to the progression of knee osteoarthritis. The hip joint and surrounding muscles have been shown to influence the amount of stress occurring at the knee joint during walking. In particular, the hip abductor muscles may have an effect on the knee joint by controlling the position of the pelvis and/or by acting as lateral stabilizers for the knee.

Research suggests that the function of the hip muscles during walking may be decreased in people with knee osteoarthritis and that greater loads may be placed on the knee joint as a result. Thus, interventions aimed at strengthening the hip abductor muscles may be effective for reducing stress on the arthritic knee and slowing the rate of progression of knee osteoarthritis.

The design of the study is a two-group pretest-posttest design using an untreated control group. Thirty-five individuals with medial compartment knee osteoarthritis will be recruited through newspaper advertisements and from the practices of orthopedic surgeons in Kingston, Ontario. Each participant with knee osteoarthritis will be matched with an asymptomatic volunteer for age (+/- 5 years), height (+/- 5 cm), mass (+/- 5 kg) and gender. Participants in the control group will have no clinical or radiographic diagnosis of knee or hip osteoarthritis or rheumatoid arthritis and no history of hip or knee trauma or pain.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- age greater than or equal to 40 years

- self-reported pain in the knee(s) for most days of the month

- at least some difficulty in daily function due to knee osteoarthritis

- radiographic evidence of knee osteoarthritis or documented evidence of cartilage loss in the knee by arthroscopy surgery or magnetic resonance imaging.

Exclusion Criteria:

- corticosteroid injection into either knee within the previous three months

- other significant medical problems (including significant heart disease, stroke and active treatment for cancer) that would prevent participants from being able to perform a hip exercise program or to participate in tests of walking performance and hip muscle strength

- known osteoarthritis or previous trauma affecting one or both hips

- previous replacement of any joint in the lower extremities.

- receiving rehabilitation services for knee osteoarthritis or performing a hip strengthening program at the time of testing

- participants who have had a dual-energy x-ray absorptiometry (DEXA) for bone density analysis or more than one x-ray of the chest, abdomen or hip in the past 6 months

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
home exercise program for the hip abductor muscles
All patients with knee OA will be taught a home-based exercise program for the hip abductor muscles during the initial visit. Patients will be instructed in the following program: contraction of the gluteus medius muscle during functional activities (gait, stepping sideways up on a step and standing on one leg); and side lying isotonic hip abduction exercises using graded resistance elastic bands positioned around the distal thighs. The program will be performed 3 times per week for 8 weeks and subjects will record exercise frequency and level of resistance on exercise calendars. Follow-up visits will occur at the end of week 1 and week 4 for review and progression of exercises. A telephone follow-up call will occur for support and participants will be encouraged to call with any questions or concerns.

Locations

Country Name City State
Canada School of Rehabilitation Therapy, Queen's University Kingston Ontario

Sponsors (1)

Lead Sponsor Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Walking variables: hip and knee abductor and adductor moments baseline and after 8 weeks No
Primary Muscle strength measures: isometric and isokinetic peak torque measures for the hip abductor and adductor muscles baseline and after 8 weeks No
Secondary Radiographs: lower limb frontal plane alignment measures - limb alignment in degrees; grading of knee osteoarthritis severity (total score out of 13) baseline No
Secondary Speed of performance on the Five-Times-Sit-to-Stand Test baseline and after 8 weeks No
Secondary Total score on the WOMAC pain subscale and the WOMAC physical function subscale baseline and after 8 weeks No
Secondary Total score obtained for the physical activity scale (PASE) baseline and after 8 weeks No
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