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Functional Exercise After Total Hip Replacement (FEATHER)

This study is not yet open for participant recruitment.
Verified September 2012 by Health Service Executive, Ireland
Sponsor:
Information provided by (Responsible Party):
Brenda Monaghan, Health Service Executive, Ireland
ClinicalTrials.gov Identifier:
NCT01683201
First received: September 7, 2012
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Hip Surgery Corrective
 Procedure: Functional exercise class
Procedure: usual care group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Functional Exercise After Total Hip Replacement: A Randomised Controlled Late Phase Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Health Service Executive, Ireland:

Primary Outcome Measures:
  • WOMAC Western Ontario and Mc Master osteoarthritis index questionaire [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
    Multi dimensional self administered health status instrument used to measure changes in the dimensions of pain stiffness and function.


Secondary Outcome Measures:
  • Six minute walk test, [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Physical performance test used to measure the distance covered in a set timeframe.

  • Short form SF-36 [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
    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.

  • Berg Balance Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 SF36, 6 min walk test, Berg balance score and a blinded radiologist will also measure glut med cross sectional area using real time ultrasound at week 12 and week 18.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683201

Contacts
Contact: Brenda M Monaghan, BSc MSc 00353872947992 brenda.monaghan@hse.ie

Sponsors and Collaborators
Health Service Executive, Ireland
Investigators
Principal Investigator: Brenda M Monaghan, BSc, MSc HSE Ireland
  More Information

No publications provided by Health Service Executive, Ireland

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

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
Study First Received: September 7, 2012
Last Updated: September 13, 2012
Health Authority: Ireland: Health Service Executive

Keywords provided by Health Service Executive, Ireland:
Total hip replacement
Functional exercise class
Randomised controlled trial

ClinicalTrials.gov processed this record on May 22, 2013