Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Total Hip Joint Replacement Behavioral: Strength training program Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Targeted Strengthening Program Following Total Hip Replacement.
Study Start Date : May 2003
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement




Primary Outcome Measures :
  1. Lower limb strength using a step test

Secondary Outcome Measures :
  1. Pain, stiffness and function using the WOMAC questionnaire.
  2. Function using the Timed Up-and-Go Test.
  3. Quality of life using the AQoL
  4. Spatiotemporal measures of walking using an instrumented mat.
  5. Hip joint torques using 3-D motion analysis.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222300


Locations
Layout table for location information
Australia, Victoria
Austin Health
Melbourne, Victoria, Australia, 3084
Sponsors and Collaborators
University of Melbourne
Investigators
Layout table for investigator information
Principal Investigator: Mary P Galea, PhD University of Melbourne

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00222300     History of Changes
Other Study ID Numbers: H2002/01532
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 8, 2006
Last Verified: October 2003
Keywords provided by University of Melbourne:
Total hip replacement
Strength training
Gait analysis