Functional Exercise After Total Hip Replacement (FEATHER)
|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.|
|ClinicalTrials.gov Identifier: NCT01683201|
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : March 20, 2015
|Condition or disease||Intervention/treatment|
|Hip Surgery Corrective||Procedure: Functional exercise class Procedure: usual care group|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|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|
|Study Start Date :||September 2012|
|Primary Completion Date :||January 2014|
|Study Completion Date :||February 2015|
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
Procedure: usual care group
Usual care group adhere to post operative instructions given on discharge from hospital
- 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.
- 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.
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
|Principal Investigator:||Brenda M Monaghan, BSc, MSc||HSE Ireland|