Functional Exercise After Total Hip Replacement (FEATHER)

March 18, 2015 updated by: Brenda Monaghan, Health Service Executive, Ireland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 YEARS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six minute walk test,
Time Frame: 3 years
Physical performance test used to measure the distance covered in a set timeframe.
3 years
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 YEARS
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.
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Service Executive, Ireland

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 7, 2012

First Submitted That Met QC Criteria

September 10, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HPF/2011/60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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