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Functional Exercise After Total Hip Replacement (FEATHER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01683201
First Posted: September 11, 2012
Last Update Posted: March 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brenda Monaghan, Health Service Executive, Ireland
  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 (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:


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

Primary Outcome Measures:
  • 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:
  • Six minute walk test, [ Time Frame: 3 years ]
    Physical performance test used to measure the distance covered in a set timeframe.

  • 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.

  • 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.

  • 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.


Enrollment: 72
Study Start Date: September 2012
Study Completion Date: February 2015
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 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.

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683201


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

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
First Submitted: September 7, 2012
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