- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00414557
Knee Malalignment and Thigh Muscle Strengthening in Individuals With Medial Knee Arthritis
The Effects of Knee Malalignment and Quadriceps Strengthening on the Adduction Moment in Individuals With Medial Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although quadriceps strengthening is the cornerstone of physiotherapy management, recent evidence suggests that high quadriceps strength in patients with malaligned knees may increase OA progression.
This study investigates the effects of quadriceps strengthening on the adduction moment in patients with medial knee OA with and without malalignment. 107 participants with and without varus knee malalignment were recruited and randomised into an exercise or a control group. Participants in the exercise group were taught five quadriceps strengthening exercises by a project physiotherapist to be performed five days a week for twelve weeks at home. The exercises were:
- Quadriceps exercise over fulcrum using ankle weight
- Straight leg raise exercise using ankle weight
- Long arc knee extension exercise in sitting using ankle weight
- Knee extension exercise with isometric hold at 60° knee flexion using ankle weight
- Knee extension exercise with isometric hold at 60° knee flexion using an elastic band.
Each exercise was performed at 2x10 repetitions for the first 2 weeks and 3x10 repetitions thereafter.
Participants visited the physiotherapist 7 times at Week 1, 2, 3, 4, 5, 7 and 10. They were given the ankle weights and elastic band to bring home and instructed about the repetitions and weights to use by the physiotherapist, who also checked and progressed their exercises. The average duration of the physiotherapy sessions was 30 minutes. To monitor compliance, each participant was given an exercise instructions sheet and kept a training diary to record the exercises they had done.
The control group received no intervention.
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3040
- The University of Melbourne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pain in the knee
- Osteophytes on knee x-ray
- Self-reported pain on the inner aspect of the study knee
- Osteophytes in the medial compartment of the knee joint and
- Medial joint space narrowing greater than lateral joint space narrowing on x-ray
Exclusion Criteria:
- Knee surgery within the previous 6 months
- History of lower limb joint replacements
- Systemic arthritic conditions such as rheumatic or psoriatic arthritis
- Valgus knee deformity (> 5º)
- Inability to walk without the use of walking aids
- Intending to start a lower limb strengthening program in the next 3 months
- Seeking or currently receiving physiotherapy for OA knee
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Adduction moment
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Time points: 0 and 13 weeks
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Secondary Outcome Measures
Outcome Measure |
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Time points: 0 and 13 weeks
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
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Numerical rating scales for pain
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Quadriceps and hamstrings strength
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Self-selected walking speed
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Dynamic balance using step test
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Physical function using stair climb test
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rana Hinman, PhD, University of Melbourne
- Principal Investigator: Tim Wrigley, MSc, University of Melbourne
- Principal Investigator: Boon W Lim, MSc, University of Melbourne
- Principal Investigator: Leena Sharma, MD, Northwestern University Medical School, Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 040850
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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