Functional Exercise After Total Hip Replacement (FEATHER)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hip Surgery Corrective	Procedure: Functional exercise class; Procedure: usual care group	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	72 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Health Services Research
Official Title:	Functional Exercise After Total Hip Replacement: A Randomised Controlled Late Phase Trial
Study Start Date :	September 2012
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	February 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Functional exercise class; Functional exercise class 45 mins twice weekly from week 12 to week 18	Procedure: Functional exercise class; Functional exercise class running twice weekly for six weeks from week 12 to week 18
Placebo Comparator: Usual Care Group; Usual Care	Procedure: usual care group; Usual care group adhere to post operative instructions given on discharge from hospital

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Six minute walk test, [ Time Frame: 3 years ]
   Physical performance test used to measure the distance covered in a set timeframe.
2. Short form SF- 12 [ Time Frame: 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.
3. HiP Abduction Strength Dynamometry [ Time Frame: 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.
4. Real time ultrasound imaging of the gluteus medius muscles [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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 -

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Health Service Executive, Ireland

Investigators

Principal Investigator:	Brenda M Monaghan, BSc, MSc	HSE Ireland

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Monaghan B, Cunningham P, Harrington P, Hing W, Blake C, O' Dohertya D, Cusack T. Randomised controlled trial to evaluate a physiotherapy-led functional exercise programme after total hip replacement. Physiotherapy. 2017 Sep;103(3):283-288. doi: 10.1016/j.physio.2016.01.003. Epub 2016 Feb 15.

Monaghan B, Grant T, Hing W, Cusack T. Functional exercise after total hip replacement (FEATHER): a randomised control trial. BMC Musculoskelet Disord. 2012 Nov 28;13:237. doi: 10.1186/1471-2474-13-237.

Responsible Party:	Brenda Monaghan, Principal Investigator Clinical Specialist Physiotherapist, Health Service Executive, Ireland
ClinicalTrials.gov Identifier:	NCT01683201 History of Changes
Other Study ID Numbers:	HPF/2011/60
First Posted:	September 11, 2012
Last Update Posted:	March 20, 2015
Last Verified:	March 2015

Keywords provided by Brenda Monaghan, Health Service Executive, Ireland:

Total hip replacement; Functional exercise class; Randomised controlled trial