<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/NCT03762577</url>
  </required_header>
  <id_info>
    <org_study_id>30146</org_study_id>
    <nct_id>NCT03762577</nct_id>
  </id_info>
  <brief_title>Effects of Ground-based Walking Training in Pulmonary Hypertension</brief_title>
  <official_title>A Randomized Controlled Trial of Ground-based Walking Training for Adult Patients With Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</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>
      Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined&#xD;
      as an increase in pulmonary artery pressure ≥25 mmHg when measured at resting with symptoms&#xD;
      such as dyspnea, fatigue, chest pain, and syncope. PH characterized by decreased exercise&#xD;
      capacity, quality of life, peripheral muscle strength, balance, and physical inactivity. It&#xD;
      is recommended that patients with PH should be included in cardiopulmonary rehabilitation&#xD;
      programs in addition to medical treatment. Ground-based walking training is a safe and&#xD;
      effective method for COPD patients. In the literature, there are no studies evaluating the&#xD;
      effects of ground-based walking training in PH patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this project is to determine the effect of ground-based walking training on&#xD;
      physical activity, exercise capacity, balance, peripheral muscle strength and quality of life&#xD;
      in patients with PH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">March 4, 2020</completion_date>
  <primary_completion_date type="Actual">March 4, 2020</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endurance exercise capacity</measure>
    <time_frame>8 weeks</time_frame>
    <description>endurance shuttle walk test</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Training Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training group will attend ground-based walking training under the supervision of a physiotherapist for 2 days and 30 minutes a week. Patients will walk for 1-2 days in a week without supervision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient education will be given and no intervention will be made.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ground-based walking training</intervention_name>
    <description>Patients will attend a 2-day 30-minute ground-based walking training under the supervision of a physiotherapist. Patients will walk for 1-2 days in a week without supervision. According to the Modified Borg Scale, the dyspnea intensity will be 3-4 (medium to slightly difficult) and the heart rate will be completed to not exceed 120 min / pulse. Heart rate of patients will be followed by finger type pulse oximeter</description>
    <arm_group_label>Training Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-80 years&#xD;
&#xD;
          -  Diagnosed with PH&#xD;
&#xD;
          -  Followed by the department of chest diseases at least six months&#xD;
&#xD;
          -  Not participating in the rehabilitation program in last year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Functional group four due to WHO functional classification&#xD;
&#xD;
          -  PH due to left heart diseases, PH due to lung diseases and/or hypoxia&#xD;
&#xD;
          -  Treatment and medication change in the last three months&#xD;
&#xD;
          -  Cooperation problems&#xD;
&#xD;
          -  Patients with successful pulmonary endarterectomy operation&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Patients with uncontrolled cardiovascular diseases&#xD;
&#xD;
          -  Patients with orthopeadic and/or neurologic disorders that could limit exercise tests&#xD;
&#xD;
          -  Syncope history in recent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ozge Ertan</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Ozge Ertan</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Pulmonary Hypertension</keyword>
  <keyword>Walking Training</keyword>
  <keyword>Exercise</keyword>
  <keyword>Balance</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</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/NCT03762577
org study id: 30146
nct id: NCT03762577
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined
      as an increase in pulmonary artery pressure ≥25 mmHg when measured at resting with symptoms
      such as dyspnea, fatigue, chest pain, and syncope. PH characterized by decreased exercise
      capacity, quality of life, peripheral muscle strength, balance, and physical inactivity. It
      is recommended that patients with PH should be included in cardiopulmonary rehabilitation
      programs in addition to medical treatment. Ground-based walking training is a safe and
      effective method for COPD patients. In the literature, there are no studies evaluating the
      effects of ground-based walking training in PH patients.
The aim of this project is to determine the effect of ground-based walking training on
      physical activity, exercise capacity, balance, peripheral muscle strength and quality of life
      in patients with PH.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Endurance exercise capacity
time frame: 8 weeks
description: endurance shuttle walk test
arm group label: Training Group
arm group type: Experimental
description: Training group will attend ground-based walking training under the supervision of a physiotherapist for 2 days and 30 minutes a week. Patients will walk for 1-2 days in a week without supervision.
arm group label: Control Group
arm group type: No Intervention
description: Patient education will be given and no intervention will be made.
intervention type: Other
intervention name: Ground-based walking training
description: Patients will attend a 2-day 30-minute ground-based walking training under the supervision of a physiotherapist. Patients will walk for 1-2 days in a week without supervision. According to the Modified Borg Scale, the dyspnea intensity will be 3-4 (medium to slightly difficult) and the heart rate will be completed to not exceed 120 min / pulse. Heart rate of patients will be followed by finger type pulse oximeter
arm group label: Training Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Ozge Ertan
investigator title: Physiotherapist
mesh term: Hypertension, Pulmonary
mesh term: Hypertension