Completed

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

What is being tested

Functional exercise class

+ usual care group

Procedure

Who is being recruted

Over 50 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Services Research Study

Placebo-Controlled

Interventional

Study Start: September 2012

See protocol details

Summary

Principal SponsorHealth Service Executive, Ireland

Last updated: March 20, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01683201

Principal SponsorHealth Service Executive, Ireland

Last updated: March 20, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate

12 weeks post primary THR for osteoarthritis

Able to Mobilize independently 15m without crutches and /or stick -Passed by the referring Orthopaedic Consultant as suitable for inclusion at six week appointment -

Able to participate in an exercise programme without physical assistance

Able to read and understand and instructions in English

Show More Criteria

3 exclusion criteria prevent from participating

Any central or peripheral nervous system deficits

Any underlying terminal disease -Any suspicion of infection following joint replacement -

Medically unstable

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Functional exercise class 45 mins twice weekly from week 12 to week 18

Group II

Placebo

Usual Care

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers