<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/NCT03022942</url>
  </required_header>
  <id_info>
    <org_study_id>Lacap UFPE</org_study_id>
    <nct_id>NCT03022942</nct_id>
  </id_info>
  <brief_title>Efficacy of Costal Mobilization Techniques and Manual Diaphragm Release Technique in Patients COPD</brief_title>
  <official_title>Efficacy of Costal Mobilization Techniques and Diaphragm Release in Thoracoabdominal Kinematics, Diaphragm Mobility and Submaximal Functional Capacity in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Pernambuco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Pernambuco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the acute and chronic effects of costal mobilization techniques and diaphragmatic&#xD;
      release in chest cavity kinematics, diaphragmatic mobility and functional capacity in&#xD;
      patients with chronic obstructive pulmonary disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study will be a controlled clinical trial in which participants will be randomized into 2&#xD;
      groups: GROUP A (costal mobilization techniques and Manual Diaphragm Release Technique),&#xD;
      GROUP B (Manual Diaphragm Release Technique). After the initial evaluation, participants will&#xD;
      undergo six sessions of care according to randomization and will be reevaluated in 3&#xD;
      following situations: immediately after the first session, at the end of treatment and one&#xD;
      week after the last session. The evaluation will be performed through Optoelectronic&#xD;
      plethysmography , Pollar, Ultrasound and 6-minutes walk test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mobility of the thoracic cage</measure>
    <time_frame>Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)</time_frame>
    <description>Will be measured by optoelectronic plestimography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diaphragma mobility</measure>
    <time_frame>Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)</time_frame>
    <description>Will be measured with ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional capacity</measure>
    <time_frame>Three weeks total: after two weeks of intervention and after one week without treatment (follow up)</time_frame>
    <description>Will be measured six minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate variability</measure>
    <time_frame>1 day: before and after the intervention</time_frame>
    <description>Will be measured Pollar</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Copd</condition>
  <condition>Chest Disorders</condition>
  <condition>Diaphragmatic Disorder</condition>
  <arm_group>
    <arm_group_label>Costal mobilization &amp; Diaphragm Release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Costal mobilization. Lying: two sets of ten deep respiratory cycles with one minute interval between sets. Sitting: two series with interval of one minute between them. Manual Diaphragm Release Technique: will be applied during two series of ten deep respiratory cycles, with one minute interval between sets.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual Diaphragm Release</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Manual Diaphragm Release Technique: will be applied during two series of ten deep respiratory cycles, with one minute interval between sets.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GROUP Costal mobilization &amp; Diaphragm Release</intervention_name>
    <description>Costal mobilization technique (Rib raising): The patient will be lying. The Therapist supports the last four pulps of both hands at the rib angles, gently traverses the rib angles in the posterior-anterior direction, using the stretcher as a lever to facilitate the elevation of the costal angles. Siting: The Therapist hugs the patient by supporting the ribs of the fingers at the rib angles, gently traverses the rib angles bilaterally in the anterior-lateral direction. Manual Diaphragm Release Technique: The therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage.</description>
    <arm_group_label>Costal mobilization &amp; Diaphragm Release</arm_group_label>
    <other_name>GROUP Rib Raising &amp; Diaphragm Release</other_name>
    <other_name>GROUP A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GROUP Manual Diaphragm Release</intervention_name>
    <description>The therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage.</description>
    <arm_group_label>Manual Diaphragm Release</arm_group_label>
    <other_name>GROUP B</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of COPD (spirometry with FEV1 &lt;80% and FEV1 / FVC &lt;0.7) of both sexes, who&#xD;
             are not undergoing another physiotherapeutic treatment, from to 21 years of age,&#xD;
             clinically stable without exacerbation in the last 6 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with rheumatic or orthopedic diseases;&#xD;
&#xD;
          -  Deformities / abnormalities in the spine that compromise the mechanics of the&#xD;
             respiratory system;&#xD;
&#xD;
          -  Rib fracture for less than 1 year;&#xD;
&#xD;
          -  Respiratory co-morbidities;&#xD;
&#xD;
          -  History of thoracic or abdominal surgery for less than 1 year;&#xD;
&#xD;
          -  Osteoporosis and IMC &gt; 30kg / m²&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HELENA M ROCHA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal de Pernambuco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>HELENA M ROCHA</last_name>
    <email>hmr.fisio@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidade Federal de Pernambuco</name>
      <address>
        <city>Recife</city>
        <state>Pernambuco</state>
        <zip>50670-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>HELENA M ROCHA</last_name>
      <email>hmr.fisio@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Pernambuco</investigator_affiliation>
    <investigator_full_name>HELENA MEDEIROS ROCHA</investigator_full_name>
    <investigator_title>Graduate</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03022942
org study id: Lacap UFPE
nct id: NCT03022942
lead sponsor: 
has dmc: Yes
To evaluate the acute and chronic effects of costal mobilization techniques and diaphragmatic
      release in chest cavity kinematics, diaphragmatic mobility and functional capacity in
      patients with chronic obstructive pulmonary disease
Study will be a controlled clinical trial in which participants will be randomized into 2
      groups: GROUP A (costal mobilization techniques and Manual Diaphragm Release Technique),
      GROUP B (Manual Diaphragm Release Technique). After the initial evaluation, participants will
      undergo six sessions of care according to randomization and will be reevaluated in 3
      following situations: immediately after the first session, at the end of treatment and one
      week after the last session. The evaluation will be performed through Optoelectronic
      plethysmography , Pollar, Ultrasound and 6-minutes walk test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Mobility of the thoracic cage
time frame: Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)
description: Will be measured by optoelectronic plestimography
measure: Diaphragma mobility
time frame: Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)
description: Will be measured with ultrasonography
measure: functional capacity
time frame: Three weeks total: after two weeks of intervention and after one week without treatment (follow up)
description: Will be measured six minute walk test
measure: heart rate variability
time frame: 1 day: before and after the intervention
description: Will be measured Pollar
arm group label: Costal mobilization & Diaphragm Release
arm group type: Experimental
description: Costal mobilization. Lying: two sets of ten deep respiratory cycles with one minute interval between sets. Sitting: two series with interval of one minute between them. Manual Diaphragm Release Technique: will be applied during two series of ten deep respiratory cycles, with one minute interval between sets.
arm group label: Manual Diaphragm Release
arm group type: Active Comparator
description: Manual Diaphragm Release Technique: will be applied during two series of ten deep respiratory cycles, with one minute interval between sets.
intervention type: Other
intervention name: GROUP Costal mobilization & Diaphragm Release
description: Costal mobilization technique (Rib raising): The patient will be lying. The Therapist supports the last four pulps of both hands at the rib angles, gently traverses the rib angles in the posterior-anterior direction, using the stretcher as a lever to facilitate the elevation of the costal angles. Siting: The Therapist hugs the patient by supporting the ribs of the fingers at the rib angles, gently traverses the rib angles bilaterally in the anterior-lateral direction. Manual Diaphragm Release Technique: The therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage.
arm group label: Costal mobilization & Diaphragm Release
other name: GROUP Rib Raising & Diaphragm Release
other name: GROUP A
intervention type: Other
intervention name: GROUP Manual Diaphragm Release
description: The therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage.
arm group label: Manual Diaphragm Release
other name: GROUP B
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: HELENA M ROCHA
role: Principal Investigator
affiliation: Universidade Federal de Pernambuco
last name: HELENA M ROCHA
email: hmr.fisio@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Pernambuco
investigator full name: HELENA MEDEIROS ROCHA
investigator title: Graduate
sharing ipd: Undecided