<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/NCT02217423</url>
  </required_header>
  <id_info>
    <org_study_id>34609514100005502</org_study_id>
    <nct_id>NCT02217423</nct_id>
  </id_info>
  <brief_title>Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy</brief_title>
  <acronym>RACCRPPT</acronym>
  <official_title>The Relationship Between Abdominal Circumference and Cardiorespiratory Repercussions in Hospitalized Patients Submitted to Physical Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Sao Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Sao Carlos</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the hospitalized patients with increased&#xD;
      waist circumference exhibit cardiorespiratory alterations after chest physical therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The physiotherapist assessment will consist of anthropometry (body mass index, abdominal&#xD;
      circumference, adipometer); chest inspection and palpation, vital signs (blood pressure,&#xD;
      heart rate, respiratory frequence, oxymetry), dyspnea index and capillar blood glucose; and&#xD;
      later with pulmonary tests (thoracoabdominal perimetry, respiratory muscle strength and&#xD;
      pulmonary volume and capacity). This will be a quasi-experimental study. Patients will be&#xD;
      divided into four groups according to waist circumference (increased or not, with respect to&#xD;
      cardiovascular risk) and respiratory disorders (obstructive and restrictive). After this&#xD;
      assessment, chest physical therapy will begin according to the protocol for obstructive and&#xD;
      restrictive respiratory disorders. The treatment will have an average duration of 30 minutes.&#xD;
      At the end of treatment (single session) the patient will be assessed again after five and&#xD;
      thirty minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in spirometric measures.</measure>
    <time_frame>Baseline, five and thirty minutes.</time_frame>
    <description>The spirometry is used to assess chest volume and capacity of individual patients respiratory disease and their response to therapy and is regarded as the gold standard measure of respiratory function. The following variables were recorded; forced vital capacity, forced expiratory volume achieved in 1 second.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of pulse oxymetry before/after chest physiotherapy. Comparison of blood pressure before/after chest physiotherapy.</measure>
    <time_frame>Baseline, five and thirty minutes.</time_frame>
    <description>The pulse oxymetry or pulse oximeter is used to measure peripheral oxygen saturation.&#xD;
The arterial blood pressure (systolic and diastolic) will be measured by sphygmomanometer to follow the displacement.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Comparison of heart rate variability before/after chest physiotherapy. Comparison of thoracoabdominal perimetry before/after chest physiotherapy.</measure>
    <time_frame>Baseline, five and thirty minutes.</time_frame>
    <description>Heart rate variability has become the conventionally accepted term to describe variations of both instantaneous heart rate and intervals (time domain).&#xD;
Thoracoabdominal perimetry consists of a set of measurements of thoracic and abdominal circumferences during respiratory movements, and it aims at quantifying the thoracoabdominal mobility.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Obesity, Abdominal</condition>
  <condition>Lung Disease</condition>
  <arm_group>
    <arm_group_label>Obstructive increased AC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient with obstructive respiratory disease with increased abdominal circumference.&#xD;
chest physiotherapy. Chest physiotherapy airway clearance modality. The protocol consisted of breathing exercises during 30 minutes and included: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest wall (compression, vibration) and cough.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obstructive disfunction with normal AC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with obstructive respiratory disease with normal abdominal circumference.&#xD;
Patient with obstructive respiratory disease with increased abdominal circumference.&#xD;
chest physiotherapy. Chest physiotherapy airway clearance modality. The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest wall (compression, vibration) and cough.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Restrictive increased AC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with restrictive respiratory disease with increased abdominal circumference. chest physiotherapy chest wall expansion.&#xD;
The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression) and incentive spirometry.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Restrictive disfunction with normal AC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with restrictive respiratory disease with normal abdominal circumference.&#xD;
Chest physiotherapy chest wall expansion. The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression) and incentive spirometry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chest physiotherapy chest wall expansion</intervention_name>
    <description>chest physiotherapy The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression, Incentive Spirometry).</description>
    <arm_group_label>Restrictive disfunction with normal AC</arm_group_label>
    <arm_group_label>Restrictive increased AC</arm_group_label>
    <other_name>Chest physiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chest physiotherapy airway clearance modality</intervention_name>
    <description>The protocol will be consisted the breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest (vibration, compression) and active cough.</description>
    <arm_group_label>Obstructive disfunction with normal AC</arm_group_label>
    <arm_group_label>Obstructive increased AC</arm_group_label>
    <other_name>Chest physical therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients (&gt; 18 years old), clinical stability characterized by axillary body&#xD;
             temperature below 38 ° C, hemoglobin higher than 7 g / dL, oxygen saturation by pulse&#xD;
             oximetry greater than or equal to 88%, mean arterial pressure (MAP) greater than 70 or&#xD;
             less than 120 mm Hg, heart rate between 50 bpm to 140 bpm ; ability to understand,&#xD;
             carry out the commands appropriately for evaluative tests, with the Glasgow Coma Scale&#xD;
             score greater than 8, locomotor integrity of the lower limbs, spontaneous breathing,&#xD;
             lack of hospital physiotherapy during hospitalization, prescription for respiratory&#xD;
             therapy; bronchodilator, if applicable four hours before intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inadequate perform to the maneuvers of the evaluation (e.g. spirometry), hemodynamic&#xD;
             instability, thoracic dermal injury, disabling orthopedic complications that&#xD;
             compromise the techniques of assessment and intervention, lymphedema of the trunk;&#xD;
             sudden weight gain with edema in limbs, ascites, nephrotic syndrome, congestive heart&#xD;
             failure, liver cirrhosis, erysipelas, deep vein thrombosis, heart bypass, heart&#xD;
             transplantation, arrhythmias, atrioventricular block, severe dyspnea (Borg&gt; 5), spinal&#xD;
             cord injury, hemoptysis, osteoporosis, recent surgeries, coagulopathy, bronchopleural&#xD;
             fistula, subcutaneous emphysema, presence of diabetes mellitus associated with cardiac&#xD;
             autonomic dysfunction, bronchoconstriction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruno Martinelli, Me</last_name>
    <role>Principal Investigator</role>
    <affiliation>UFSCar</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Estadual Manoel de Abreu</name>
      <address>
        <city>Bauru</city>
        <state>SP</state>
        <zip>17051-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>December 6, 2015</last_update_submitted>
  <last_update_submitted_qc>December 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Sao Carlos</investigator_affiliation>
    <investigator_full_name>Bruno Martinelli</investigator_full_name>
    <investigator_title>Me</investigator_title>
  </responsible_party>
  <keyword>Physical Therapy Modalities</keyword>
  <keyword>Respiration Disorders</keyword>
  <keyword>Respiratory Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Obesity, Abdominal</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/NCT02217423
org study id: 34609514100005502
nct id: NCT02217423
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether the hospitalized patients with increased
      waist circumference exhibit cardiorespiratory alterations after chest physical therapy.
The physiotherapist assessment will consist of anthropometry (body mass index, abdominal
      circumference, adipometer); chest inspection and palpation, vital signs (blood pressure,
      heart rate, respiratory frequence, oxymetry), dyspnea index and capillar blood glucose; and
      later with pulmonary tests (thoracoabdominal perimetry, respiratory muscle strength and
      pulmonary volume and capacity). This will be a quasi-experimental study. Patients will be
      divided into four groups according to waist circumference (increased or not, with respect to
      cardiovascular risk) and respiratory disorders (obstructive and restrictive). After this
      assessment, chest physical therapy will begin according to the protocol for obstructive and
      restrictive respiratory disorders. The treatment will have an average duration of 30 minutes.
      At the end of treatment (single session) the patient will be assessed again after five and
      thirty minutes.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change from baseline in spirometric measures.
time frame: Baseline, five and thirty minutes.
description: The spirometry is used to assess chest volume and capacity of individual patients respiratory disease and their response to therapy and is regarded as the gold standard measure of respiratory function. The following variables were recorded; forced vital capacity, forced expiratory volume achieved in 1 second.
measure: Comparison of pulse oxymetry before/after chest physiotherapy. Comparison of blood pressure before/after chest physiotherapy.
time frame: Baseline, five and thirty minutes.
description: The pulse oxymetry or pulse oximeter is used to measure peripheral oxygen saturation.
The arterial blood pressure (systolic and diastolic) will be measured by sphygmomanometer to follow the displacement.
measure: Comparison of heart rate variability before/after chest physiotherapy. Comparison of thoracoabdominal perimetry before/after chest physiotherapy.
time frame: Baseline, five and thirty minutes.
description: Heart rate variability has become the conventionally accepted term to describe variations of both instantaneous heart rate and intervals (time domain).
Thoracoabdominal perimetry consists of a set of measurements of thoracic and abdominal circumferences during respiratory movements, and it aims at quantifying the thoracoabdominal mobility.
arm group label: Obstructive increased AC
arm group type: Experimental
description: Patient with obstructive respiratory disease with increased abdominal circumference.
chest physiotherapy. Chest physiotherapy airway clearance modality. The protocol consisted of breathing exercises during 30 minutes and included: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest wall (compression, vibration) and cough.
arm group label: Obstructive disfunction with normal AC
arm group type: Experimental
description: Patients with obstructive respiratory disease with normal abdominal circumference.
Patient with obstructive respiratory disease with increased abdominal circumference.
chest physiotherapy. Chest physiotherapy airway clearance modality. The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest wall (compression, vibration) and cough.
arm group label: Restrictive increased AC
arm group type: Experimental
description: Patients with restrictive respiratory disease with increased abdominal circumference. chest physiotherapy chest wall expansion.
The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression) and incentive spirometry.
arm group label: Restrictive disfunction with normal AC
arm group type: Experimental
description: Patients with restrictive respiratory disease with normal abdominal circumference.
Chest physiotherapy chest wall expansion. The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression) and incentive spirometry.
intervention type: Other
intervention name: Chest physiotherapy chest wall expansion
description: chest physiotherapy The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression, Incentive Spirometry).
arm group label: Restrictive disfunction with normal AC
arm group label: Restrictive increased AC
other name: Chest physiotherapy
intervention type: Other
intervention name: Chest physiotherapy airway clearance modality
description: The protocol will be consisted the breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest (vibration, compression) and active cough.
arm group label: Obstructive disfunction with normal AC
arm group label: Obstructive increased AC
other name: Chest physical therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bruno Martinelli, Me
role: Principal Investigator
affiliation: UFSCar
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Sao Carlos
investigator full name: Bruno Martinelli
investigator title: Me
mesh term: Lung Diseases
mesh term: Obesity, Abdominal