Clinical trial NCT01683201: Functional Exercise After Total Hip Replacement
Official title: Functional Exercise After Total Hip Replacement: A Randomised Controlled Late Phase Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Surgery Corrective
Keywords: Total hip replacement
Functional exercise class
Randomised controlled trial
Lead sponsor: Health Service Executive, Ireland
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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 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 -

Primary outcomes:
measure: WOMAC Western Ontario and Mc Master osteoarthritis index questionaire
timeFrame: 3 YEARS
Secondary outcomes:
measure: Six minute walk test,
timeFrame: 3 years
measure: Short form SF- 12
timeFrame: 3 YEARS
measure: HiP Abduction Strength Dynamometry
timeFrame: 3 years
measure: Real time ultrasound imaging of the gluteus medius muscles
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: HSE Ireland
name: Brenda M Monaghan, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monaghan B, Cunningham P, Harrington P, Hing W, Blake C, O' Dohertya D, Cusack T. Randomised controlled trial to evaluate a physiotherapy-led functional exercise programme after total hip replacement. Physiotherapy. 2017 Sep;103(3):283-288. doi: 10.1016/j.physio.2016.01.003. Epub 2016 Feb 15.
citation: 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;13:237. doi: 10.1186/1471-2474-13-237.