<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/NCT04502043</url>
  </required_header>
  <id_info>
    <org_study_id>SchulthessKlinik</org_study_id>
    <nct_id>NCT04502043</nct_id>
  </id_info>
  <brief_title>Exercise Therapy for Femoroacetabular Impingement Syndrome</brief_title>
  <acronym>SWEaT</acronym>
  <official_title>The Effect of Patients' Characteristics on the Responsiveness to Exercise Therapy for the Management of Femoroacetabular Impingement Syndrome: a Multi-center, Single-group, Intervention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schulthess Klinik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kantonsspital Winterthur KSW</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Schulthess Klinik</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the clinical trial is to investigate the characteristics of patients, who respond&#xD;
      vs. not respond to exercise therapy for the nonsurgical management of femoroacetabular&#xD;
      impingement syndrome (FAIS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with a diagnosis of FAIS will be recruited from 2 clinical centers and will receive&#xD;
      exercise therapy (study intervention). Exercise therapy is a semi-standardized intervention&#xD;
      and will last 12 weeks (3 months). Hip pain, function and quality of life will be assessed&#xD;
      using a patient-reported questionnaire at baseline, 3, 6 and 12 months' follow-up. Hip joint&#xD;
      contact pressure will be evaluated using motion analysis and modelling at baseline, 3 and 12&#xD;
      months' follow-up. Hip morphology will be evaluated using imaging at baseline and hip surgery&#xD;
      rate will be evaluated at 6 and 12 months' follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in hip pain, function and quality of life</measure>
    <time_frame>Baseline to 6 months' follow-up</time_frame>
    <description>Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in hip pain, function and quality of life</measure>
    <time_frame>Baseline to 12 months' follow-up</time_frame>
    <description>Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hip pain, function and quality of life</measure>
    <time_frame>Baseline to 3 months' follow-up</time_frame>
    <description>Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hip joint contact stress</measure>
    <time_frame>Baseline to 3 months' follow-up</time_frame>
    <description>Hip joint contact pressure will be assessed using modelling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hip joint contact stress</measure>
    <time_frame>Baseline to 12 months' follow-up</time_frame>
    <description>Hip joint contact pressure will be assessed using modelling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip morphology</measure>
    <time_frame>Baseline</time_frame>
    <description>Hip morphology will be assessed using imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sport activity level</measure>
    <time_frame>Baseline to 3 months' follow-up</time_frame>
    <description>Sport activity level will be assessed using the Hip Sports Activity Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sport activity level</measure>
    <time_frame>Baseline to 6 months' follow-up</time_frame>
    <description>Sport activity level will be assessed using the Hip Sports Activity Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sport activity level</measure>
    <time_frame>Baseline to 12 months' follow-up</time_frame>
    <description>Sport activity level will be assessed using the Hip Sports Activity Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip surgery rate</measure>
    <time_frame>6 months' follow-up</time_frame>
    <description>Number of patients who will decide to undergo hip surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip surgery rate</measure>
    <time_frame>12 months' follow-up</time_frame>
    <description>Number of patients who will decide to undergo hip surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dropout</measure>
    <time_frame>3 months' follow-up</time_frame>
    <description>Number of patients who will not complete the non-surgical intervention protocol</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Femoroacetabular Impingement Syndrome</condition>
  <arm_group>
    <arm_group_label>Exercise therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise therapy consists of improving dynamic hip joint stability by means of hip-specific and functional lower limb strengthening, core stability and postural balance exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise therapy</intervention_name>
    <description>Education&#xD;
Hip-specific strengthening exercises&#xD;
Functional lower limb strengthening exercises&#xD;
Core stability exercises&#xD;
Postural balance exercises</description>
    <arm_group_label>Exercise therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 to 50 years;&#xD;
&#xD;
          -  Diagnosis of FAIS;&#xD;
&#xD;
          -  Availability of magnetic resonance arthrography and anteroposterior pelvic radiography&#xD;
             of the involved hip;&#xD;
&#xD;
          -  Signed informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous hip surgery;&#xD;
&#xD;
          -  Any surgery on the lower extremities in the last 6 months;&#xD;
&#xD;
          -  Hip dysplasia: lateral center edge angle &lt;25°;&#xD;
&#xD;
          -  Hip osteoarthritis: Tönnis grade &gt;1;&#xD;
&#xD;
          -  BMI: &gt;35 kg/m2;&#xD;
&#xD;
          -  Significant cardiopulmonary diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicola C Casartelli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schulthess Klinik</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicola C Casartelli, PhD</last_name>
    <phone>0443857971</phone>
    <phone_ext>+41</phone_ext>
    <email>nicola.casartelli@kws.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Schulthess Clinic</name>
      <address>
        <city>Zurich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola C Casartelli, PhD</last_name>
      <phone>0443857971</phone>
      <phone_ext>+41</phone_ext>
      <email>nicola.casartelli@kws.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 14, 2019</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Femoracetabular Impingement</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT04502043
org study id: SchulthessKlinik
nct id: NCT04502043
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the clinical trial is to investigate the characteristics of patients, who respond
      vs. not respond to exercise therapy for the nonsurgical management of femoroacetabular
      impingement syndrome (FAIS).
Patients with a diagnosis of FAIS will be recruited from 2 clinical centers and will receive
      exercise therapy (study intervention). Exercise therapy is a semi-standardized intervention
      and will last 12 weeks (3 months). Hip pain, function and quality of life will be assessed
      using a patient-reported questionnaire at baseline, 3, 6 and 12 months' follow-up. Hip joint
      contact pressure will be evaluated using motion analysis and modelling at baseline, 3 and 12
      months' follow-up. Hip morphology will be evaluated using imaging at baseline and hip surgery
      rate will be evaluated at 6 and 12 months' follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in hip pain, function and quality of life
time frame: Baseline to 6 months' follow-up
description: Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items
measure: Change in hip pain, function and quality of life
time frame: Baseline to 12 months' follow-up
description: Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items
measure: Change in hip pain, function and quality of life
time frame: Baseline to 3 months' follow-up
description: Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items
measure: Change in hip joint contact stress
time frame: Baseline to 3 months' follow-up
description: Hip joint contact pressure will be assessed using modelling
measure: Change in hip joint contact stress
time frame: Baseline to 12 months' follow-up
description: Hip joint contact pressure will be assessed using modelling
measure: Hip morphology
time frame: Baseline
description: Hip morphology will be assessed using imaging
measure: Change in sport activity level
time frame: Baseline to 3 months' follow-up
description: Sport activity level will be assessed using the Hip Sports Activity Scale
measure: Change in sport activity level
time frame: Baseline to 6 months' follow-up
description: Sport activity level will be assessed using the Hip Sports Activity Scale
measure: Change in sport activity level
time frame: Baseline to 12 months' follow-up
description: Sport activity level will be assessed using the Hip Sports Activity Scale
measure: Hip surgery rate
time frame: 6 months' follow-up
description: Number of patients who will decide to undergo hip surgery
measure: Hip surgery rate
time frame: 12 months' follow-up
description: Number of patients who will decide to undergo hip surgery
measure: Dropout
time frame: 3 months' follow-up
description: Number of patients who will not complete the non-surgical intervention protocol
arm group label: Exercise therapy
arm group type: Experimental
description: Exercise therapy consists of improving dynamic hip joint stability by means of hip-specific and functional lower limb strengthening, core stability and postural balance exercises.
intervention type: Other
intervention name: Exercise therapy
description: Education
Hip-specific strengthening exercises
Functional lower limb strengthening exercises
Core stability exercises
Postural balance exercises
arm group label: Exercise therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Nicola C Casartelli, PhD
role: Principal Investigator
affiliation: Schulthess Klinik
last name: Nicola C Casartelli, PhD
phone: 0443857971
phone ext: +41
email: nicola.casartelli@kws.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Femoracetabular Impingement
mesh term: Syndrome
mesh term: Rotator Cuff Injuries