Functional Exercise After Total Hip Replacement

Hip Surgery Corrective Clinical Trial

— FEATHER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683201
• Other study ID #: HPF/2011/60
• Status: Completed
• Phase: N/A
• First received: September 7, 2012
• Last updated: March 18, 2015
• Start date: September 2012
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Health Service Executive, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Health Service Executive
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 -

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hip Surgery Corrective

Intervention

Procedure:
• Functional exercise class
Functional exercise class running twice weekly for six weeks from week 12 to week 18
• usual care group
Usual care group adhere to post operative instructions given on discharge from hospital

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Health Service Executive, Ireland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC Western Ontario and Mc Master osteoarthritis index questionaire	Multi dimensional self administered health status instrument used to measure changes in the dimensions of pain stiffness and function.	3 YEARS	No
Secondary	Six minute walk test,	Physical performance test used to measure the distance covered in a set timeframe.	3 years	No
Secondary	Short form SF- 12	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 YEARS	No
Secondary	HiP Abduction Strength Dynamometry	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.	3 years	No
Secondary	Real time ultrasound imaging of the gluteus medius muscles	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.	3 years	No