NCT00222300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

August 8, 2006

Status Verified

October 1, 2003

First QC Date

September 13, 2005

Last Update Submit

August 7, 2006

Conditions

Total Hip Joint Replacement

Keywords

Total hip replacementStrength trainingGait analysis

Outcome Measures

Primary Outcomes (1)

  • Lower limb strength using a step test

Secondary Outcomes (5)

  • 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.

Interventions

Strength training programBEHAVIORAL

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

Location

Study Officials

  • Mary P Galea, PhD

    University of Melbourne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

May 1, 2003

Study Completion

December 1, 2005

Last Updated

August 8, 2006

Record last verified: 2003-10

Locations

AU(1)