<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/NCT02249455</url>
  </required_header>
  <id_info>
    <org_study_id>14\305</org_study_id>
    <nct_id>NCT02249455</nct_id>
  </id_info>
  <brief_title>Effectiveness of Acapella and ELTGOL Technique to Promote Airway Clearance in COPD:a Comparative Study</brief_title>
  <official_title>Effectiveness of Acapella and ELTGOL (Expiration in Lateral Position With Open Glottis)Technique to Promote Airway Clearance in COPD Patients:a Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PSG College of Physiotherapy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PSG College of Physiotherapy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique in&#xD;
      promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is carried out to determine the effectiveness of acapella and expiration in&#xD;
      lateral position with open glottis to clear the secretion in COPD patients. The sessions will&#xD;
      be carried twice daily for twenty minutes. The outcome measures are values of pre and post&#xD;
      intervention fev1/fvc and breathlessness cough sputum scale. Duration of the study will be&#xD;
      for five days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">January 2015</completion_date>
  <primary_completion_date type="Anticipated">December 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Force expiratory volume in one second</measure>
    <time_frame>change from baseline at 30 minutes</time_frame>
    <description>Fev1/fvc values were noted after pre and post intervention of airway clearance manoeuver</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in breathlessness cough sputum score</measure>
    <time_frame>change from baseline at 5 days</time_frame>
    <description>Bcss scale was interviewed to the patient on first day and the fifth day. The changes were noted.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Acapella</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acapella is given to the patients twice daily for 20 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ELTGOL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Expiration with open glottis in lateral position is done twice daily for 20 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional physiotherapy like breathing exercise, active coughing, chest mobilisation was encouraged twice daily for 20 min.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acapella</intervention_name>
    <description>Treatment time for 20 min twice daily</description>
    <arm_group_label>Acapella</arm_group_label>
    <other_name>ACAPELLA DHD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ELTGOL</intervention_name>
    <description>ELTGOL technique 20 min twice daily</description>
    <arm_group_label>ELTGOL</arm_group_label>
    <other_name>Expiration in lateral position with open glottis for twenty min twice daily.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional physiotherapy</intervention_name>
    <description>Conventional physiotherapy was given twice daily for 20 min</description>
    <arm_group_label>conventional physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild copd&#xD;
&#xD;
          -  Moderate copd&#xD;
&#xD;
          -  Patient able to sustain expiratory flow greater than 15l/min&#xD;
&#xD;
          -  Patient expectorate more than 25.-30ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe copd&#xD;
&#xD;
          -  Peripheral oxygen saturation lower than 85%&#xD;
&#xD;
          -  Rr&gt;35breaths/min&#xD;
&#xD;
          -  Current acute chest pain&#xD;
&#xD;
          -  Recent history of haemoptysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>steffi varghese, mpt</last_name>
    <role>Principal Investigator</role>
    <affiliation>psg ims&amp;r</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>steffi varghese, mpt</last_name>
    <phone>9677465724</phone>
    <email>steffivarghesep@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Steffi Varghese</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamilnadu</state>
        <zip>641004</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>mahesh, mpt</last_name>
      <phone>04222570170</phone>
    </contact>
    <contact_backup>
      <last_name>shanmugapriya, mpt</last_name>
      <phone>04222570170</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 23, 2014</last_update_submitted>
  <last_update_submitted_qc>September 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>PSG College of Physiotherapy</investigator_affiliation>
    <investigator_full_name>STEFFI VARGHESE P</investigator_full_name>
    <investigator_title>post graduate in cardiopulmonary rehabiltation</investigator_title>
  </responsible_party>
  <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/NCT02249455
org study id: 14\305
nct id: NCT02249455
lead sponsor: 
has dmc: Yes
To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique in
      promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients
This study is carried out to determine the effectiveness of acapella and expiration in
      lateral position with open glottis to clear the secretion in COPD patients. The sessions will
      be carried twice daily for twenty minutes. The outcome measures are values of pre and post
      intervention fev1/fvc and breathlessness cough sputum scale. Duration of the study will be
      for five days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Force expiratory volume in one second
time frame: change from baseline at 30 minutes
description: Fev1/fvc values were noted after pre and post intervention of airway clearance manoeuver
measure: Change in breathlessness cough sputum score
time frame: change from baseline at 5 days
description: Bcss scale was interviewed to the patient on first day and the fifth day. The changes were noted.
arm group label: Acapella
arm group type: Experimental
description: Acapella is given to the patients twice daily for 20 min.
arm group label: ELTGOL
arm group type: Experimental
description: Expiration with open glottis in lateral position is done twice daily for 20 min
arm group label: conventional physiotherapy
arm group type: Active Comparator
description: Conventional physiotherapy like breathing exercise, active coughing, chest mobilisation was encouraged twice daily for 20 min.
intervention type: Device
intervention name: Acapella
description: Treatment time for 20 min twice daily
arm group label: Acapella
other name: ACAPELLA DHD
intervention type: Other
intervention name: ELTGOL
description: ELTGOL technique 20 min twice daily
arm group label: ELTGOL
other name: Expiration in lateral position with open glottis for twenty min twice daily.
intervention type: Other
intervention name: conventional physiotherapy
description: Conventional physiotherapy was given twice daily for 20 min
arm group label: conventional physiotherapy
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: steffi varghese, mpt
role: Principal Investigator
affiliation: psg ims&r
last name: steffi varghese, mpt
phone: 9677465724
email: steffivarghesep@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
responsible party type: Principal Investigator
investigator affiliation: PSG College of Physiotherapy
investigator full name: STEFFI VARGHESE P
investigator title: post graduate in cardiopulmonary rehabiltation
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive