- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00222300
A Targeted Strengthening Program Following Total Hip Replacement.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total Hip Replacement (THR) is a common surgical procedure performed in people with hip osteoarthritis and appears to be effective in relieving pain and improving function. However significant quadriceps atrophy and weakness persist post-operatively. Although relief of pain and improvement of function are important outcomes following THR, weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes, public transport and results in persistent gait abnormalities. Since lower limb weakness is one of the risk factors for falls, it is important that this is appropriately addressed.
The study examines the effect of an eight-week task-specific strengthening program on lower limb function in patients following THR in a randomized controlled trial. The experimental program is being conducted as a circuit in a gymnasium environment. Changes on specific measures of physical function of patients in the Experimental Group will be compared with those of patients in a Control Group who will continue with the standard care program provided at Austin Health.
Outcome measures include:lower limb muscle strength using a step test, pain, stiffness, and function as reported on the WOMAC questionnaire, quality of life using the AQoL questionnaire, the Timed Up-and-Go test. Walking tests will also be conducted. These include:
- Walking pattern, recorded on an instrumented mat
- Walking endurance measured by the 6-minute walk test.
- Analysis of hip joint torques using 3-D motion analysis.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3084
- Austin Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary uncomplicated total hip joint replacement 6-8 weeks prior to enrolment.
- able to walk 45m independently with or without walking aid.
- able to comprehend instructions
- prior joint replacement on the other side at least 12 months previously
Exclusion Criteria:
- unable to fully weight-bear on affected limb
- pre-existing neurological or orthopaedic condition affecting gait
- revision surgery
- post-operative complications, e.g. wound infection
- uncontrolled systemic disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Lower limb strength using a step test
|
Secondary Outcome Measures
Outcome Measure |
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Pain, stiffness and function using the WOMAC questionnaire.
|
Function using the Timed Up-and-Go Test.
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Quality of life using the AQoL
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Spatiotemporal measures of walking using an instrumented mat.
|
Hip joint torques using 3-D motion analysis.
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- H2002/01532
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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