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Functional Exercise After Total Hip Replacement (FEATHER)

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

September 7, 2012
September 13, 2012
September 2012
January 2014   (final data collection date for primary outcome measure)
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.
WOMAC Western Ontario and Mc Master osteoarthritis index questionaire QUESTIONAIRE [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
Single blind randomised controlled trial with two arms
Complete list of historical versions of study NCT01683201 on ClinicalTrials.gov Archive Site
  • 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.
  • Six minute walk test, [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Short form SF-36 [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
  • Berg Balance Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Assesment 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
Not Provided
Not Provided
 
Functional Exercise After Total Hip Replacement
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Hip Surgery Corrective
  • Procedure: Functional exercise class
    Functional exercise class running twice weekly for six weeks from week 12 to week 18
  • Procedure: usual care group
    Usual care group adhere to post operative instructions given on discharge from hospital
  • Experimental: Functional exercise class
    Functional exercise class 45 mins twice weekly from week 12 to week 18
    Intervention: Procedure: Functional exercise class
  • Placebo Comparator: Usual Care Group
    Usual Care
    Intervention: Procedure: usual care group
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(1):237. doi: 10.1186/1471-2474-13-237.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
January 2015
January 2014   (final data collection date for primary outcome measure)

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 -
Both
50 Years and older
Yes
Contact: Brenda M Monaghan, BSc MSc 00353872947992 brenda.monaghan@hse.ie
Not Provided
 
NCT01683201
HPF/2011/60
No
Brenda Monaghan, Health Service Executive, Ireland
Health Service Executive, Ireland
Not Provided
Principal Investigator: Brenda M Monaghan, BSc, MSc HSE Ireland
Health Service Executive, Ireland
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP