Functional Exercise After Total Hip Replacement

Not Applicable

Completed

• Conditions: Hip Surgery Corrective
• Interventions: Procedure: Functional exercise class; Procedure: usual care group

• Registration Number: NCT01683201
• Lead Sponsor: Health Service Executive, Ireland

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-11
• Primary Completion: 2014-01
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional exercise class	Functional exercise class	Functional exercise class 45 mins twice weekly from week 12 to week 18
Usual Care Group	usual care group	Usual Care

Primary Outcome Measures

Name	Time	Method
WOMAC Western Ontario and Mc Master osteoarthritis index questionaire	3 YEARS	Multi dimensional self administered health status instrument used to measure changes in the dimensions of pain stiffness and function.

Secondary Outcome Measures

Name	Time	Method
Six minute walk test,	3 years	Physical performance test used to measure the distance covered in a set timeframe.
Short form SF- 12	3 YEARS	Self completed questionaire that measures health status and quality of life under eight multi item scales measuring physical function, bodily pain, role limitation due to physical health problems, general health, vitality, social function, role limitation due to emotional problems and mental health.
HiP Abduction Strength Dynamometry	3 years	Assessment scale of ability to maintain balance both statically and whilst performing various functional tasks will be completed by the principal investigator at week 12 and repeated for all patients at week 18.
Real time ultrasound imaging of the gluteus medius muscles	3 years	Patients will be scanned by a blinded radiologist to measure cross sectional area of the gluteus medius muscle at 12 weeks and again at 18 weeks.