<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/NCT01735474</url>
  </required_header>
  <id_info>
    <org_study_id>DF0035UG</org_study_id>
    <nct_id>NCT01735474</nct_id>
  </id_info>
  <brief_title>Results of Manual Therapy on Pulmonary Parameters</brief_title>
  <official_title>Manual Therapy Results on Pulmonary Function and Musculoskeletal Movement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Granada</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to evaluate the effectiveness of different manual&#xD;
      techniques included traditionally on respiratory physical therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized controlled trial. Participants are classified in two groups and they are assessed&#xD;
      using pulmonary functions parameters and thoracic and spinal movements.&#xD;
&#xD;
      There are two interventions: placebo and a manual technique. Participants will be assessed&#xD;
      again at the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Sample size was not completed&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2017</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>spirometry parameters</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Change from baseline to postintervention in spirometry parameters (Vital capacity, Forced expiratory volume in the first second (FEV1), Tidal volume)using a spirometer as recommended by the American Thoracic Society.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>thoracic movement</measure>
    <time_frame>at baseline, 6 months</time_frame>
    <description>Changes from baseline to postintervention in thoracic movement, measured by tape measure in 3 thoracic levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Functionality scores</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>Functional status questionnaire used before and after intervention to measure functionality scores change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on cardiorespiratory capacity</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>Changes on cardiorespiratory capacity measured by 6MWT (6 minutes walking test)at baseline and post intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>spinal movement</measure>
    <time_frame>at baseline, 6 months</time_frame>
    <description>Changes from baseline to postintervention in spinal movement, measured by Range of motion with goniometer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Respiratory Disease</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 people are recruited in order to the inclusion criteria for the study. Placebo controlled.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 people are recruited in order to the inclusion criteria for the study. Experimental group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual technique</intervention_name>
    <description>A manual technique is employed in the intervention group based on passive movement and stretching of the respiratory system.&#xD;
The manual technique includes:&#xD;
stretching of diaphragm. Mobilization. Potentiation of the respiratory muscles.</description>
    <arm_group_label>Manual technique</arm_group_label>
    <other_name>Manual therapy.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Usual care</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>No intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects with respiratory conditions&#xD;
&#xD;
          -  Must be able to do spirometry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with acute processes in their pathologies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carmen M Valenza, PH MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Granada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of health Sciences. University of Granada</name>
      <address>
        <city>Granada</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 2, 2016</last_update_submitted>
  <last_update_submitted_qc>November 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Marie Carmen Valenza</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>manual therapy</keyword>
  <keyword>respiratory disease</keyword>
  <keyword>thoracic movement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_browse>
  <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/NCT01735474
org study id: DF0035UG
nct id: NCT01735474
lead sponsor: 
has dmc: Yes
The main objective of this study is to evaluate the effectiveness of different manual
      techniques included traditionally on respiratory physical therapy
Randomized controlled trial. Participants are classified in two groups and they are assessed
      using pulmonary functions parameters and thoracic and spinal movements.

      There are two interventions: placebo and a manual technique. Participants will be assessed
      again at the end of the study.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: spirometry parameters
time frame: Baseline, 6 months
description: Change from baseline to postintervention in spirometry parameters (Vital capacity, Forced expiratory volume in the first second (FEV1), Tidal volume)using a spirometer as recommended by the American Thoracic Society.
measure: thoracic movement
time frame: at baseline, 6 months
description: Changes from baseline to postintervention in thoracic movement, measured by tape measure in 3 thoracic levels.
measure: Changes on Functionality scores
time frame: baseline, 6 months
description: Functional status questionnaire used before and after intervention to measure functionality scores change.
measure: Changes on cardiorespiratory capacity
time frame: baseline, 6 months
description: Changes on cardiorespiratory capacity measured by 6MWT (6 minutes walking test)at baseline and post intervention.
measure: spinal movement
time frame: at baseline, 6 months
description: Changes from baseline to postintervention in spinal movement, measured by Range of motion with goniometer.
arm group label: Placebo
arm group type: Placebo Comparator
description: 30 people are recruited in order to the inclusion criteria for the study. Placebo controlled.
arm group label: Manual technique
arm group type: Active Comparator
description: 30 people are recruited in order to the inclusion criteria for the study. Experimental group.
intervention type: Other
intervention name: Manual technique
description: A manual technique is employed in the intervention group based on passive movement and stretching of the respiratory system.
The manual technique includes:
stretching of diaphragm. Mobilization. Potentiation of the respiratory muscles.
arm group label: Manual technique
other name: Manual therapy.
intervention type: Other
intervention name: Placebo
description: Usual care
arm group label: Placebo
other name: No intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carmen M Valenza, PH MD
role: Principal Investigator
affiliation: Universidad de Granada
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Marie Carmen Valenza
investigator title: assistant professor
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
sharing ipd: Undecided