<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/NCT02212184</url>
  </required_header>
  <id_info>
    <org_study_id>Manual Therapy in COPD</org_study_id>
    <nct_id>NCT02212184</nct_id>
  </id_info>
  <brief_title>Diaphragm Release Manual Technique Efficacy in COPD Patients</brief_title>
  <official_title>Diaphragm Release Manual Technique Efficacy on Diaphragmatic Mobility, Respiratory Muscle Strength and Exercise Performance in COPD Patients: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helga Cecília Muniz de Souza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidade Federal de Pernambuco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Federal de Pernambuco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this study are to evaluate the effects of Diaphragm Release Manual Technique on&#xD;
      diaphragm mobility, chest wall kinematics and functional capacity of COPD patients. Methods:&#xD;
      Randomized controlled trial (double blinded) with COPD patients, allocated in two group:&#xD;
      intervention (IG) who will receive the Diaphragm Release manual technique on 6&#xD;
      non-consecutive sessions and control group (CG), who will receive a sham protocol (light&#xD;
      touch) with the same parameters of IG. Outcomes will be evaluated as: immediate and post&#xD;
      treatment effects (after 1 and 6 sessions respectively). The primary outcome analysed will be&#xD;
      the diaphragm displacement (ultrasonography evaluation) and secondary outcomes will comprise&#xD;
      abdominal and chest wall kinematics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">October 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diaphragm mobility</measure>
    <time_frame>Diaphragm mobility at first session and after two weeks of treatment.</time_frame>
    <description>To evaluate diaphragmatic mobility a high-resolution ultrasound SonoaceR3 (Samsung Medison - South Korea) with a 3.5 MHz convex transducer will be used. Volunteers will remain in a supine position and receive verbal command to perform Inspiratory capacity maneuvers (IC), and the measurement of each curve referring to the diaphragmatic displacement (in mm) will be performed immediately after obtaining the images. The maneuvers will be repeated until obtaining 5 satisfactory images. The average of the three highest values not differing by more than 10% between their values should be accepted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compartmental Chest wall volume</measure>
    <time_frame>Compartmental Chest wall volume evaluated by Opto-electronic Plethysmograph at the first session and after two weeks of treatment</time_frame>
    <description>Compartmental Chest wall volume will be measured by Opto-electronic Plethysmograph (OEP) (BTS Bioengineering, Italy) with 89 reflective markers placed on volunteer´s skin surface using a hypoallergenic adhesive on specific anatomical points of the chest wall and abdomen. Thus, changes in chest wall volumes are going to be calculated, allowing to acquire total chest wall volume (Vcw) and the division into three compartments, namely: pulmonary rib cage (Rc,p), abdominal rib cage (Rc,a) and abdomen (Ab) during quiet breathing, inspiratory capacity (IC) and vital capacity (VC), maneuvers.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Six-minute walking distance</measure>
    <time_frame>Six-minute walking distance (6MWD) evaluated by 6 minutes walking test at the first session and after two weeks of treatment</time_frame>
    <description>Six-minute walking tests (6MWT) will be performed in accordance to the ATS/ERS criteria, in the moments: Pre 1st session and Pre 6th session.</description>
  </other_outcome>
  <other_outcome>
    <measure>Respiratory muscle strength</measure>
    <time_frame>Respiratory muscle strength measured by manovacuometry at the first session and after two weeks of treatment</time_frame>
    <description>Maximum inspiratory and expiratory pressures (MIP, MEP) will be obtained from the residual volume and total lung capacity, respectively, according to ATS/ERS criteria using a portable digital manometer, model MVD 300 (® MDI Ltda, Brazil). With the same instrument, the patient's nasal inspiratory pressure (SNIP) will also be assessed by placing the nasal plug into one nostril, without contralateral occlusion. Ten Sniff maneuvers should be performed with maximal inspiratory effort (60 seconds between each) and the greatest value achieved will be considered.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Manual Diaphragm release technique (sham) In attempt to execute the sham protocol the therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib. The therapist will hold only light touch in the landmarks, without exerting pressure or traction. The maneuver will be performed in two sets of ten deep breaths, with an one minute interval between them.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intevention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will receive the Manual Diaphragm Release Technique, during 6 days of treatment. They will undertake four evaluations throughout treatment: before and immediately after the Day 1 (Baseline 1 and Post 1) and before and after Day 6 (Baseline 6 and Post 6).&#xD;
In the other Days (2nd to 5th) patients will only receive the intervention and won't be evaluated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Diaphragm Release Technique</intervention_name>
    <description>The therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib, and guiding forearms toward the shoulders of the corresponding side. During inspiration, pulls the points of contact with both hands, in the direction of the head, accompanying the elevation movement of the ribs. During exhalation, deepens contact toward the inner costal, maintaining resistance. 2 sets x 10 breaths (1 min interval). Treatment will last two weeks (6 sessions) All patients will undertake four evaluations throughout treatment: Baseline Day 1 and post Day 1; Baseline Day 6 and post Day 6.</description>
    <arm_group_label>Intevention Group</arm_group_label>
    <other_name>Manual Diaphragm Stretching Technique</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Diaphragm release technique (sham)</intervention_name>
    <description>Manual Diaphragm release technique (sham) In attempt to execute the sham protocol the therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib. The therapist will hold only light touch in the landmarks, without exerting pressure or traction. The maneuver will be performed in two sets of ten deep breaths, with an one minute interval between them.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CPOD patients&#xD;
&#xD;
          -  ex-smokers&#xD;
&#xD;
          -  clinically stable patients (no exacerbation in the previous 6 weeks)&#xD;
&#xD;
          -  forced expiratory volume in one second (FEV1) &lt; than 80% predicted&#xD;
&#xD;
          -  FEV1/FVC ≤ 0.7, post bronchodilator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiopulmonary diseases&#xD;
&#xD;
          -  BMI &gt; 30.0 kg/m2&#xD;
&#xD;
          -  History of thoracic surgery&#xD;
&#xD;
          -  Denial to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Armele D de Andrade, Post Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Federal de Pernambuco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UFPernambuco</name>
      <address>
        <city>Recife</city>
        <state>Pernambuco</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>June 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Pernambuco</investigator_affiliation>
    <investigator_full_name>Helga Cecília Muniz de Souza</investigator_full_name>
    <investigator_title>MsC</investigator_title>
  </responsible_party>
  <keyword>Diaphragm</keyword>
  <keyword>COPD</keyword>
  <keyword>Musculoskeletal Manipulations</keyword>
  <keyword>Ultrasonography</keyword>
  <keyword>Optoelectronic Plethysmography.</keyword>
  <!-- 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/NCT02212184
org study id: Manual Therapy in COPD
nct id: NCT02212184
lead sponsor: 
collaborator: 
has dmc: Yes
The aims of this study are to evaluate the effects of Diaphragm Release Manual Technique on
      diaphragm mobility, chest wall kinematics and functional capacity of COPD patients. Methods:
      Randomized controlled trial (double blinded) with COPD patients, allocated in two group:
      intervention (IG) who will receive the Diaphragm Release manual technique on 6
      non-consecutive sessions and control group (CG), who will receive a sham protocol (light
      touch) with the same parameters of IG. Outcomes will be evaluated as: immediate and post
      treatment effects (after 1 and 6 sessions respectively). The primary outcome analysed will be
      the diaphragm displacement (ultrasonography evaluation) and secondary outcomes will comprise
      abdominal and chest wall kinematics.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Diaphragm mobility
time frame: Diaphragm mobility at first session and after two weeks of treatment.
description: To evaluate diaphragmatic mobility a high-resolution ultrasound SonoaceR3 (Samsung Medison - South Korea) with a 3.5 MHz convex transducer will be used. Volunteers will remain in a supine position and receive verbal command to perform Inspiratory capacity maneuvers (IC), and the measurement of each curve referring to the diaphragmatic displacement (in mm) will be performed immediately after obtaining the images. The maneuvers will be repeated until obtaining 5 satisfactory images. The average of the three highest values not differing by more than 10% between their values should be accepted.
measure: Compartmental Chest wall volume
time frame: Compartmental Chest wall volume evaluated by Opto-electronic Plethysmograph at the first session and after two weeks of treatment
description: Compartmental Chest wall volume will be measured by Opto-electronic Plethysmograph (OEP) (BTS Bioengineering, Italy) with 89 reflective markers placed on volunteer´s skin surface using a hypoallergenic adhesive on specific anatomical points of the chest wall and abdomen. Thus, changes in chest wall volumes are going to be calculated, allowing to acquire total chest wall volume (Vcw) and the division into three compartments, namely: pulmonary rib cage (Rc,p), abdominal rib cage (Rc,a) and abdomen (Ab) during quiet breathing, inspiratory capacity (IC) and vital capacity (VC), maneuvers.
measure: Six-minute walking distance
time frame: Six-minute walking distance (6MWD) evaluated by 6 minutes walking test at the first session and after two weeks of treatment
description: Six-minute walking tests (6MWT) will be performed in accordance to the ATS/ERS criteria, in the moments: Pre 1st session and Pre 6th session.
measure: Respiratory muscle strength
time frame: Respiratory muscle strength measured by manovacuometry at the first session and after two weeks of treatment
description: Maximum inspiratory and expiratory pressures (MIP, MEP) will be obtained from the residual volume and total lung capacity, respectively, according to ATS/ERS criteria using a portable digital manometer, model MVD 300 (® MDI Ltda, Brazil). With the same instrument, the patient's nasal inspiratory pressure (SNIP) will also be assessed by placing the nasal plug into one nostril, without contralateral occlusion. Ten Sniff maneuvers should be performed with maximal inspiratory effort (60 seconds between each) and the greatest value achieved will be considered.
arm group label: Control Group
arm group type: Sham Comparator
description: Manual Diaphragm release technique (sham) In attempt to execute the sham protocol the therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib. The therapist will hold only light touch in the landmarks, without exerting pressure or traction. The maneuver will be performed in two sets of ten deep breaths, with an one minute interval between them.
arm group label: Intevention Group
arm group type: Experimental
description: All patients will receive the Manual Diaphragm Release Technique, during 6 days of treatment. They will undertake four evaluations throughout treatment: before and immediately after the Day 1 (Baseline 1 and Post 1) and before and after Day 6 (Baseline 6 and Post 6).
In the other Days (2nd to 5th) patients will only receive the intervention and won't be evaluated.
intervention type: Other
intervention name: Manual Diaphragm Release Technique
description: The therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib, and guiding forearms toward the shoulders of the corresponding side. During inspiration, pulls the points of contact with both hands, in the direction of the head, accompanying the elevation movement of the ribs. During exhalation, deepens contact toward the inner costal, maintaining resistance. 2 sets x 10 breaths (1 min interval). Treatment will last two weeks (6 sessions) All patients will undertake four evaluations throughout treatment: Baseline Day 1 and post Day 1; Baseline Day 6 and post Day 6.
arm group label: Intevention Group
other name: Manual Diaphragm Stretching Technique
intervention type: Other
intervention name: Manual Diaphragm release technique (sham)
description: Manual Diaphragm release technique (sham) In attempt to execute the sham protocol the therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib. The therapist will hold only light touch in the landmarks, without exerting pressure or traction. The maneuver will be performed in two sets of ten deep breaths, with an one minute interval between them.
arm group label: Control Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Armele D de Andrade, Post Doctor
role: Study Director
affiliation: Universidade Federal de Pernambuco
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: Universidade Federal de Pernambuco
investigator full name: Helga Cecília Muniz de Souza
investigator title: MsC