<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/NCT02997683</url>
  </required_header>
  <id_info>
    <org_study_id>002</org_study_id>
    <nct_id>NCT02997683</nct_id>
  </id_info>
  <brief_title>3-Month Home-based Training With Whole Body Vibration Device in Patients With PAH (GALILEO-PAH-HOME)</brief_title>
  <acronym>GALILEOHOME</acronym>
  <official_title>Influence of Training With Whole Body Vibration Device on Quality of Life (QoL), Exercise Capacity, as Well as on the Effects of Muscle Power and Muscle Function in Patients With Pulmonal Arterial Hypertension (PAH) in an Extended 3-month Home Based Training. Background and Rationale for the Proposal: Capacity and the Ability to Exercise, in Patients With PAH is Limited. Primary Scientific Question Addressed:Changes in Muscle Power, Changes in 6-Minute Walk Distance (6MWD) and Changes in QoL Are to be Evaluated.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klinikum der Universität Köln</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Klinikum der Universität Köln</source>
  <oversight_info>
    <has_dmc>No</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>
      In order to evaluate Long term effects of whole Body Vibration (wbv) in patients with PAH and&#xD;
      CTEPH patients will get a training device to use at home for 3 months. Patients in the&#xD;
      Intervention group will be introduced in the training program on the wbv-device in the study&#xD;
      center 3-4 times and baseline Parameters will be collected before start of the home based&#xD;
      training. Patients randomized into the placebo arm be introduced into the training program&#xD;
      according to the interventional arm but not perfoming the exercises on the wbv-device but on&#xD;
      the floor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion&#xD;
      critera&#xD;
&#xD;
      Randomization (day -7): Subjects will be randomized to either Intervention Group (training on&#xD;
      wbv platform) or non-Intervention Group (training without wbv).&#xD;
&#xD;
      Introduction Week -1(-7d-d1): All subjects will receive introduction in their training&#xD;
&#xD;
      Month 1:&#xD;
&#xD;
      Day 1: From this day subjects are supposed to start their training accoridng to protocol&#xD;
&#xD;
      Day 2: Telephone Visit&#xD;
&#xD;
      Day 5: Telephone Visit&#xD;
&#xD;
      Day 7: Telephone Visit&#xD;
&#xD;
      Day 10: Telephone Visit&#xD;
&#xD;
      Day 13: Telephone Visit&#xD;
&#xD;
      Day 20: Telephone Visit&#xD;
&#xD;
      Day 27: Telephone Visit&#xD;
&#xD;
      Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training&#xD;
&#xD;
      Month 2:&#xD;
&#xD;
      Week 5, Day 34:&#xD;
&#xD;
      Week 6, Day 41:&#xD;
&#xD;
      Week 7, Day 48:&#xD;
&#xD;
      Week 8, Day 55:&#xD;
&#xD;
      Month 3:&#xD;
&#xD;
      Week 9, Day 62:&#xD;
&#xD;
      Week 10, Day 69:&#xD;
&#xD;
      Week 11, Day 76:&#xD;
&#xD;
      Week 12, Day 83: Final Visit&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in 6 Minute Walking distance</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in 6 Minute Walking distance</measure>
    <time_frame>4 weeks interm analysis</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of Life</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of Life</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Changes in Six Minute Walking Distance, Peak Oxygen Uptake, Quality of Life</condition>
  <arm_group>
    <arm_group_label>3-month home based training on whole body vibration platform</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This Group will receive a training device to perform their given exercises on</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3-month home based training on floor</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This Group will perform their given exercises at home on the floor</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Body Vibration platform GALILEO</intervention_name>
    <description>3 month home based training on whole Body Vibration platform GALILEO</description>
    <arm_group_label>3-month home based training on whole body vibration platform</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercises at home on the floor</intervention_name>
    <description>exercises at home on the floor</description>
    <arm_group_label>3-month home based training on floor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women age 18-90 years&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Symptomatic PAH (idiopathic, hereditary or associated with systemic scleroderma)&#xD;
&#xD;
          -  Persistend or inoperable CTEPH&#xD;
&#xD;
          -  Invasively confirmed PAH&#xD;
&#xD;
          -  6MWT ≥ 50 - 450 m&#xD;
&#xD;
          -  Stable specific therapy for at least 6 weeks&#xD;
&#xD;
          -  Ability to perform bike test&#xD;
&#xD;
          -  Ability to perform wbv training&#xD;
&#xD;
          -  NYHA/WHO-FC II-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        any other PAH/PH than idiopathic, hereditary, associated with systemic scleroderma or CTEPH&#xD;
&#xD;
          -  Rehabilitation or other training concept performed within 6 weeks before inclusion&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  acute thrombosis&#xD;
&#xD;
          -  newly implanted Hip or Knee&#xD;
&#xD;
          -  recent bone fracture&#xD;
&#xD;
          -  Disability to confirm consent&#xD;
&#xD;
          -  NYHA/WHO-FC IV&#xD;
&#xD;
          -  6MWD below 50 or above 450 m&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Felix Gerhardt, MD</last_name>
    <phone>+4947889413</phone>
    <email>felix.gerhardt@uk-koeln.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Spezialambulanz für pulmonale Hypertonie Uniklinik Köln</name>
      <address>
        <city>Köln</city>
        <state>NRW</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felix Gerhardt, PhD</last_name>
      <phone>+49221478</phone>
      <phone_ext>89413</phone_ext>
      <email>felix.gerhardt@uk-koeln.de</email>
    </contact>
    <investigator>
      <last_name>Felix Gerhardt, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>April 25, 2019</last_update_submitted>
  <last_update_submitted_qc>April 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Klinikum der Universität Köln</investigator_affiliation>
    <investigator_full_name>Felix Gerhardt</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <!-- 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/NCT02997683
org study id: 002
nct id: NCT02997683
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In order to evaluate Long term effects of whole Body Vibration (wbv) in patients with PAH and
      CTEPH patients will get a training device to use at home for 3 months. Patients in the
      Intervention group will be introduced in the training program on the wbv-device in the study
      center 3-4 times and baseline Parameters will be collected before start of the home based
      training. Patients randomized into the placebo arm be introduced into the training program
      according to the interventional arm but not perfoming the exercises on the wbv-device but on
      the floor.
Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion
      critera

      Randomization (day -7): Subjects will be randomized to either Intervention Group (training on
      wbv platform) or non-Intervention Group (training without wbv).

      Introduction Week -1(-7d-d1): All subjects will receive introduction in their training

      Month 1:

      Day 1: From this day subjects are supposed to start their training accoridng to protocol

      Day 2: Telephone Visit

      Day 5: Telephone Visit

      Day 7: Telephone Visit

      Day 10: Telephone Visit

      Day 13: Telephone Visit

      Day 20: Telephone Visit

      Day 27: Telephone Visit

      Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training

      Month 2:

      Week 5, Day 34:

      Week 6, Day 41:

      Week 7, Day 48:

      Week 8, Day 55:

      Month 3:

      Week 9, Day 62:

      Week 10, Day 69:

      Week 11, Day 76:

      Week 12, Day 83: Final Visit
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in 6 Minute Walking distance
time frame: 3 months
measure: Changes in 6 Minute Walking distance
time frame: 4 weeks interm analysis
measure: Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)
time frame: 3 months
measure: Changes in Peak Oxygen uptake in cardiopulmonary exercise testing (CPET)
time frame: 4 weeks
measure: Changes in Quality of Life
time frame: 3 months
measure: Changes in Quality of Life
time frame: 4 weeks
arm group label: 3-month home based training on whole body vibration platform
arm group type: Experimental
description: This Group will receive a training device to perform their given exercises on
arm group label: 3-month home based training on floor
arm group type: Placebo Comparator
description: This Group will perform their given exercises at home on the floor
intervention type: Device
intervention name: Body Vibration platform GALILEO
description: 3 month home based training on whole Body Vibration platform GALILEO
arm group label: 3-month home based training on whole body vibration platform
intervention type: Other
intervention name: exercises at home on the floor
description: exercises at home on the floor
arm group label: 3-month home based training on floor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Felix Gerhardt, MD
phone: +4947889413
email: felix.gerhardt@uk-koeln.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Klinikum der Universität Köln
investigator full name: Felix Gerhardt
investigator title: Dr. med.