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| Tracking Information | |||||||||||||||||||||
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| First Received Date ICMJE | December 20, 2006 | ||||||||||||||||||||
| Last Updated Date | December 21, 2006 | ||||||||||||||||||||
| Start Date ICMJE | May 2004 | ||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00414557 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Knee Malalignment and Thigh Muscle Strengthening in Individuals With Medial Knee Arthritis | ||||||||||||||||||||
| Official Title ICMJE | The Effects of Knee Malalignment and Quadriceps Strengthening on the Adduction Moment in Individuals With Medial Knee Osteoarthritis | ||||||||||||||||||||
| Brief Summary | To investigate the effects of quadriceps strengthening on the adductor moment in individuals with medial knee OA and whether quadriceps strengthening has a different effect on the adductor moment in individuals with and without knee malalignment |
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| 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:
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. |
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| Study Phase | Phase II, Phase III | ||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study | ||||||||||||||||||||
| Condition ICMJE | Knee Osteoarthritis | ||||||||||||||||||||
| Intervention ICMJE | Procedure: Quadriceps strengthening | ||||||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||||||
| Publications * | Lim BW, Hinman RS, Wrigley TV, Sharma L, Bennell KL. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008 Jul 15;59(7):943-51. | ||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||
| Enrollment ICMJE | 107 | ||||||||||||||||||||
| Completion Date | December 2006 | ||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 50 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | Australia | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT ID ICMJE | NCT00414557 | ||||||||||||||||||||
| Responsible Party | |||||||||||||||||||||
| Study ID Numbers ICMJE | 040850 | ||||||||||||||||||||
| Study Sponsor ICMJE | University of Melbourne | ||||||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Melbourne | ||||||||||||||||||||
| Verification Date | December 2006 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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