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Completed

NCT Number: NCT01683201

Functional Exercise After Total Hip Replacement

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Functional exercise class

Procedure

Functional exercise class running twice weekly for six weeks from week 12 to week 18

usual care group

Procedure

Usual care group adhere to post operative instructions given on discharge from hospital

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Health Service Executive, Ireland

Other

Registry information

Official study title

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

Acronym: FEATHER

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Sep 11, 2012
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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