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Clinical Trials/NCT01683201
NCT01683201
Completed
Not Applicable

Functional Exercise After Total Hip Replacement: A Randomised Controlled Late Phase Trial

Health Service Executive, Ireland0 sites72 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Surgery Corrective
Sponsor
Health Service Executive, Ireland
Enrollment
72
Primary Endpoint
WOMAC Western Ontario and Mc Master osteoarthritis index questionaire
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The aim of this research project is to evaluate the efficacy of a specific functional exercise programme to improve pain, stiffness and physical function in patients post total hip replacement from week 12 to week 18 post surgery.

Detailed Description

This will be a single blind randomised controlled trial with two arms. 70 subjects post primary total hip replacement will be randomised either to a functional; exercise group (n=35) or to a control group following usual care (n=35). Blinded outcome assessments will be carried out on all subjects by the principal investigator using the Western Ontario and Mc Master arthritis index on day 5 , week 12 aand week 18. Secondary outcomes measurements will also be collated at week 12 and week 18 including SF 12, 6 min walk test, Dynamometry, and a blinded radiologist will also measure glut med cross sectional area using real time ultrasound at week 12 and week 18.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
February 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Health Service Executive, Ireland
Responsible Party
Principal Investigator
Principal Investigator

Brenda Monaghan

Principal Investigator Clinical Specialist Physiotherapist

Health Service Executive, Ireland

Eligibility Criteria

Inclusion Criteria

  • 12 weeks post primary THR for osteoarthritis
  • Age 50 years and above
  • Able to read and understand and instructions in English
  • Willing to attend classes twice weekly for 8 weeks
  • Able to participate in an exercise programme without physical assistance
  • Able to Mobilize independently 15m without crutches and /or stick -Passed by the referring Orthopaedic Consultant as suitable for inclusion at six week appointment -

Exclusion Criteria

  • Medically unstable
  • Any central or peripheral nervous system deficits
  • Any underlying terminal disease -Any suspicion of infection following joint replacement -

Outcomes

Primary Outcomes

WOMAC Western Ontario and Mc Master osteoarthritis index questionaire

Time Frame: 3 YEARS

Multi dimensional self administered health status instrument used to measure changes in the dimensions of pain stiffness and function.

Secondary Outcomes

  • Six minute walk test,(3 years)
  • Short form SF- 12(3 YEARS)
  • HiP Abduction Strength Dynamometry(3 years)
  • Real time ultrasound imaging of the gluteus medius muscles(3 years)

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