<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01683201</url>
  </required_header>
  <id_info>
    <org_study_id>HPF/2011/60</org_study_id>
    <nct_id>NCT01683201</nct_id>
  </id_info>
  <brief_title>Functional Exercise After Total Hip Replacement</brief_title>
  <acronym>FEATHER</acronym>
  <official_title>Functional Exercise After Total Hip Replacement: A Randomised Controlled Late Phase Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Health Service Executive, Ireland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Health Service Executive, Ireland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this research project is to evaluate the efficacy of a specific functional&#xD;
      exercise programme to improve pain, stiffness and physical function in patients post total&#xD;
      hip replacement from week 12 to week 18 post surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single blind randomised controlled trial with two arms. 70 subjects post&#xD;
      primary total hip replacement will be randomised either to a functional; exercise group&#xD;
      (n=35) or to a control group following usual care (n=35).&#xD;
&#xD;
      Blinded outcome assessments will be carried out on all subjects by the principal investigator&#xD;
      using the Western Ontario and Mc Master arthritis index on day 5 , week 12 aand week 18.&#xD;
&#xD;
      Secondary outcomes measurements will also be collated at week 12 and week 18 including SF 12,&#xD;
      6 min walk test, Dynamometry, and a blinded radiologist will also measure glut med cross&#xD;
      sectional area using real time ultrasound at week 12 and week 18.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>WOMAC Western Ontario and Mc Master osteoarthritis index questionaire</measure>
    <time_frame>3 YEARS</time_frame>
    <description>Multi dimensional self administered health status instrument used to measure changes in the dimensions of pain stiffness and function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Six minute walk test,</measure>
    <time_frame>3 years</time_frame>
    <description>Physical performance test used to measure the distance covered in a set timeframe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short form SF- 12</measure>
    <time_frame>3 YEARS</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HiP Abduction Strength Dynamometry</measure>
    <time_frame>3 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Real time ultrasound imaging of the gluteus medius muscles</measure>
    <time_frame>3 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Hip Surgery Corrective</condition>
  <arm_group>
    <arm_group_label>Functional exercise class</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Functional exercise class 45 mins twice weekly from week 12 to week 18</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Usual Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Functional exercise class</intervention_name>
    <description>Functional exercise class running twice weekly for six weeks from week 12 to week 18</description>
    <arm_group_label>Functional exercise class</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>usual care group</intervention_name>
    <description>Usual care group adhere to post operative instructions given on discharge from hospital</description>
    <arm_group_label>Usual Care Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12 weeks post primary THR for osteoarthritis&#xD;
&#xD;
          -  Age 50 years and above&#xD;
&#xD;
          -  Able to read and understand and instructions in English&#xD;
&#xD;
          -  Willing to attend classes twice weekly for 8 weeks&#xD;
&#xD;
          -  Able to participate in an exercise programme without physical assistance&#xD;
&#xD;
          -  Able to Mobilize independently 15m without crutches and /or stick -Passed by the&#xD;
             referring Orthopaedic Consultant as suitable for inclusion at six week appointment -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically unstable&#xD;
&#xD;
          -  Any central or peripheral nervous system deficits&#xD;
&#xD;
          -  Any underlying terminal disease -Any suspicion of infection following joint&#xD;
             replacement -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brenda M Monaghan, BSc, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>HSE Ireland</affiliation>
  </overall_official>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>March 18, 2015</last_update_submitted>
  <last_update_submitted_qc>March 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Health Service Executive, Ireland</investigator_affiliation>
    <investigator_full_name>Brenda Monaghan</investigator_full_name>
    <investigator_title>Principal Investigator Clinical Specialist Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Total hip replacement</keyword>
  <keyword>Functional exercise class</keyword>
  <keyword>Randomised controlled trial</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01683201
org study id: HPF/2011/60
nct id: NCT01683201
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: WOMAC Western Ontario and Mc Master osteoarthritis index questionaire
time frame: 3 YEARS
description: Multi dimensional self administered health status instrument used to measure changes in the dimensions of pain stiffness and function.
measure: Six minute walk test,
time frame: 3 years
description: Physical performance test used to measure the distance covered in a set timeframe.
measure: Short form SF- 12
time frame: 3 YEARS
description: 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.
measure: HiP Abduction Strength Dynamometry
time frame: 3 years
description: 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.
measure: Real time ultrasound imaging of the gluteus medius muscles
time frame: 3 years
description: 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.
arm group label: Functional exercise class
arm group type: Experimental
description: Functional exercise class 45 mins twice weekly from week 12 to week 18
arm group label: Usual Care Group
arm group type: Placebo Comparator
description: Usual Care
intervention type: Procedure
intervention name: Functional exercise class
description: Functional exercise class running twice weekly for six weeks from week 12 to week 18
arm group label: Functional exercise class
intervention type: Procedure
intervention name: usual care group
description: Usual care group adhere to post operative instructions given on discharge from hospital
arm group label: Usual Care Group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Brenda M Monaghan, BSc, MSc
role: Principal Investigator
affiliation: HSE Ireland
responsible party type: Principal Investigator
investigator affiliation: Health Service Executive, Ireland
investigator full name: Brenda Monaghan
investigator title: Principal Investigator Clinical Specialist Physiotherapist