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A Targeted Strengthening Program Following Total Hip Replacement.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00222300
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 8, 2006
Sponsor:
Information provided by:
University of Melbourne

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date August 8, 2006
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Lower limb strength using a step test
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00222300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2006)
  • Pain, stiffness and function using the WOMAC questionnaire.
  • Function using the Timed Up-and-Go Test.
  • Quality of life using the AQoL
  • Spatiotemporal measures of walking using an instrumented mat.
  • Hip joint torques using 3-D motion analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Pain, stiffness and function using the WOMAC questionnaire.
  • Function using the Timed Up-and-Go Test.
  • Quality of life using the AQoL
  • Spatiotemoral measures of walking using an instrumented mat.
  • Hip joint torques using 3-D motion analysis.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Targeted Strengthening Program Following Total Hip Replacement.
Official Title  ICMJE A Targeted Strengthening Program Following Total Hip Replacement.
Brief Summary 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 wasting and weakness of the hip and knee muscles persists 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 patients undergo a strengthening program post-operatively. The hypothesis is that lower limb strength and function will be better in patients who undergo a strengthening program post-operatively than in those who have usual care.
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:

  1. Walking pattern, recorded on an instrumented mat
  2. Walking endurance measured by the 6-minute walk test.
  3. Analysis of hip joint torques using 3-D motion analysis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Total Hip Joint Replacement
Intervention  ICMJE Behavioral: Strength training program
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00222300
Other Study ID Numbers  ICMJE H2002/01532
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Melbourne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary P Galea, PhD University of Melbourne
PRS Account University of Melbourne
Verification Date October 2003

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