<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/NCT02218918</url>
  </required_header>
  <id_info>
    <org_study_id>PSG01Rehab</org_study_id>
    <nct_id>NCT02218918</nct_id>
  </id_info>
  <brief_title>Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients</brief_title>
  <acronym>GWT/TWT</acronym>
  <official_title>Phase 0 Study of Comparison Between Ground Walk Training and Treadmill Walk Training in COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PSG Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PSG Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary Rehabilitation became a vital part of management in COPD patients in form of&#xD;
      activity modification, dietary and pharmacological optimisation. But access to traditional&#xD;
      supervised aerobic (treadmill) walking is debatable fact due to economical and staffing&#xD;
      expertise in developing countries like India. The investigators designed a randomised&#xD;
      controlled trial to evaluate the effectiveness of ground based walking over traditional&#xD;
      treadmill walking in improving quality of life in COPD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: COPD is increasing mortality and morbidity globally. Pulmonary rehabilitation is&#xD;
      a promising management in COPD management. Exercise training in form of aerobic (walking,&#xD;
      cycling) and strength training is an important part of pulmonary rehabilitation. However&#xD;
      access to traditional supervised exercise programs is questionable debate even in developed&#xD;
      western countries. Unsupervised ground walk programs are often told by physicians but not&#xD;
      properly prescribed.&#xD;
&#xD;
      Objective: To assess whether ground or treadmill walk is better in improving functional&#xD;
      capacity and quality of life in COPD patients Design: Randomised controlled trial Procedure:&#xD;
      Two arms 1) supervised ground walk training 2) supervised treadmill walk training. The&#xD;
      intensity and progression of walk is based on 6 minute walk test. Quality of life will be&#xD;
      gauged through Chronic respiratory questionnaire and functional capacity through 6 minute&#xD;
      walk test.&#xD;
&#xD;
      Statistical analysis: Descriptive analysis for characterisation. Normality though Kolmogorov&#xD;
      and Variables will be compared through paired and unpaired student t tests&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>
    <intervention_model_description>Treadmill training vs ground walk training</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Capacity (6 MINUTE WALK TEST)</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>6 minute walk test according to standardisation of ATS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life (Chronic Respiratory Questionnaire)</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>CRQ - interviewer based</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>Supervised Treadmill Walk Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Based on 6 minute walk distance, treadmill speed initiated and progression on basis new 6 minute walk distance every 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supervised Ground walk training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ground walk training progressed on the basis of 6 minute walk distance (70 - 90%), Weekly 3 days and for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Ground walk training</intervention_name>
    <description>3 times a week and 6 weeks</description>
    <arm_group_label>Supervised Ground walk training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervised Treadmill Walk training</intervention_name>
    <description>3 times a week and 6 weeks</description>
    <arm_group_label>Supervised Treadmill Walk Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stable COPD&#xD;
&#xD;
          -  Stage II - IV&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular diseases uncompensated&#xD;
&#xD;
          -  uncompensated pleural diseases&#xD;
&#xD;
          -  uncompensated liver diseases&#xD;
&#xD;
          -  Recent surgeries less than 3 weeks&#xD;
&#xD;
          -  malignancy receiving chemo and radiotherapy&#xD;
&#xD;
          -  Recent exacerbations less than 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baskaran Chandrasekaran, MPTh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior Physiotherapist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PSG Hospitals</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamilnadu</state>
        <zip>641004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>October 19, 2017</last_update_submitted>
  <last_update_submitted_qc>October 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>PSG Hospitals</investigator_affiliation>
    <investigator_full_name>Baskaran Chandrasekaran</investigator_full_name>
    <investigator_title>Senior Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Ground walk</keyword>
  <keyword>treadmill walk</keyword>
  <keyword>Functional walk capacity</keyword>
  <keyword>COPD</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02218918
org study id: PSG01Rehab
nct id: NCT02218918
lead sponsor: 
has dmc: Yes
Pulmonary Rehabilitation became a vital part of management in COPD patients in form of
      activity modification, dietary and pharmacological optimisation. But access to traditional
      supervised aerobic (treadmill) walking is debatable fact due to economical and staffing
      expertise in developing countries like India. The investigators designed a randomised
      controlled trial to evaluate the effectiveness of ground based walking over traditional
      treadmill walking in improving quality of life in COPD patients.
Background: COPD is increasing mortality and morbidity globally. Pulmonary rehabilitation is
      a promising management in COPD management. Exercise training in form of aerobic (walking,
      cycling) and strength training is an important part of pulmonary rehabilitation. However
      access to traditional supervised exercise programs is questionable debate even in developed
      western countries. Unsupervised ground walk programs are often told by physicians but not
      properly prescribed.

      Objective: To assess whether ground or treadmill walk is better in improving functional
      capacity and quality of life in COPD patients Design: Randomised controlled trial Procedure:
      Two arms 1) supervised ground walk training 2) supervised treadmill walk training. The
      intensity and progression of walk is based on 6 minute walk test. Quality of life will be
      gauged through Chronic respiratory questionnaire and functional capacity through 6 minute
      walk test.

      Statistical analysis: Descriptive analysis for characterisation. Normality though Kolmogorov
      and Variables will be compared through paired and unpaired student t tests
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Treadmill training vs ground walk training
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Functional Capacity (6 MINUTE WALK TEST)
time frame: Baseline, 6 weeks
description: 6 minute walk test according to standardisation of ATS
measure: Quality of Life (Chronic Respiratory Questionnaire)
time frame: Baseline, 6 weeks
description: CRQ - interviewer based
arm group label: Supervised Treadmill Walk Training
arm group type: Active Comparator
description: Based on 6 minute walk distance, treadmill speed initiated and progression on basis new 6 minute walk distance every 2 weeks
arm group label: Supervised Ground walk training
arm group type: Experimental
description: Ground walk training progressed on the basis of 6 minute walk distance (70 - 90%), Weekly 3 days and for 6 weeks
intervention type: Behavioral
intervention name: Ground walk training
description: 3 times a week and 6 weeks
arm group label: Supervised Ground walk training
intervention type: Behavioral
intervention name: Supervised Treadmill Walk training
description: 3 times a week and 6 weeks
arm group label: Supervised Treadmill Walk Training
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Baskaran Chandrasekaran, MPTh
role: Principal Investigator
affiliation: Senior Physiotherapist
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: PSG Hospitals
investigator full name: Baskaran Chandrasekaran
investigator title: Senior Physiotherapist
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive