<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/NCT03229070</url>
  </required_header>
  <id_info>
    <org_study_id>Cycle-ergometer- PTS 2017</org_study_id>
    <nct_id>NCT03229070</nct_id>
  </id_info>
  <brief_title>Cycle-ergometer in the Postoperative of Thoracic Surgery</brief_title>
  <acronym>CE_PTS</acronym>
  <official_title>Cycle-ergometer in the Postoperative of Thoracic Surgery: A Randomized, Controlled Clinical Trial Comparing the Effect of Interval Training With Continuous Training on Performance in the Six-minute Walk Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Health Science of Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Irmandade Santa Casa de Misericórdia de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of Health Science of Porto Alegre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-lateral thoracotomies and assisted thoracic surgery (CTVA) are the main surgical&#xD;
      approaches for pulmonary resections. One of the counterpoints of these surgical approaches is&#xD;
      postoperative pain, which in addition to causing ventilatory changes and reduction of lung&#xD;
      capacities, contributes to bed rest and consequent decrease in patients' functionality. These&#xD;
      complications increase hospitalization time and hospital costs, being determinant factors for&#xD;
      perioperative morbidity and mortality. In order to prevent these outcomes of reduce the&#xD;
      functional capacity of patients, new physiotherapeutic approaches have been adopted, such as&#xD;
      the use of the cycloergometer. Recent studies show that the early use of this device brings&#xD;
      benefits such as: improved blood circulation and venous return, increased muscle strength,&#xD;
      improved functional capacity and reduced symptoms of dyspnea and fatigue. This study aims to&#xD;
      compare the effect of interval training with continuous cycle ergometer training on&#xD;
      performance in the six-minute walk test. Randomized and controlled clinical trial performed&#xD;
      with patients submitted to elective thoracic surgery, hospitalized at the intensive care unit&#xD;
      (ICU) and in the hospitalization unit of the Hospital Pavilhão Pereira Filho of the Santa&#xD;
      Casa de Misericórdia Brotherhood of Porto Alegre. Participants will be randomized into three&#xD;
      groups: control group (CG), interval exercise group (GHG) and continuous exercise group&#xD;
      (GEC). Functional capacity assessments will be performed through the six-minute walk test&#xD;
      (6MWT) and the chair sit and lift (TSL) test in 30 seconds, and evaluation of the clinical&#xD;
      state of fatigue through the revised Piper-Fatigue Scale. The evaluations will be performed&#xD;
      preoperatively and at hospital discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Will include patients between 30 and 80 years of age, of both sexes, submitted to thoracic&#xD;
      surgery with incision by posterolateral thoracotomy, as well as those submitted to&#xD;
      video-assisted thoracic surgery for pulmonary resection (bulectomy, segmentectomy, lobectomy,&#xD;
      pneumectomy).&#xD;
&#xD;
      The cycloergometer rehabilitation program will be performed twice a day for 20 minutes.&#xD;
&#xD;
      The expectation of comparing two different types of muscle overload (interval training versus&#xD;
      continuous training) is that the training of shorter duration and greater load also has a&#xD;
      greater demand on the cardiopulmonary system of these patients and, therefore, a better&#xD;
      response to the functional capacity rehabilitation program of these individuals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 26, 2017</start_date>
  <completion_date type="Anticipated">February 28, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 30, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum distance performed on six-minute test</measure>
    <time_frame>6 minutes</time_frame>
    <description>Walk in a 30m corridor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum number of times you succeed lift and sit on the chair</measure>
    <time_frame>30 seconds</time_frame>
    <description>With your arms crossed against your chest, sit up and get up from the chair</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">135</enrollment>
  <condition>Functional Capacity</condition>
  <condition>Fatigue</condition>
  <condition>Dyspnea</condition>
  <condition>Muscle Strength</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control Group: Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) and assessments at discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interval effort group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interval effort group: Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Active phase (high load) lasting 60 seconds, followed by an active recovery phase with light / moderate load (60% of the maximum load) lasting 4 minutes. The pedaling speed should be maintained between 30-60rpm. There will be 5 cycles that will total 20 minutes of physical effort, and assessments at discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous effort group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Intensity used will be mild / moderate, ie 60% of the maximum load reached in the incremental test. The pedaling speed should be maintained between 30-60rpm. The execution time, from this exercise regime will be 20 minutes, and assessments at discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interval effort group</intervention_name>
    <description>Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Active phase (high load) lasting 60 seconds, followed by an active recovery phase with light / moderate load (60% of the maximum load) lasting 4 minutes. The pedaling speed should be maintained between 30-60rpm. There will be 5 cycles that will total 20 minutes of physical effort, and assessments at discharge.</description>
    <arm_group_label>Interval effort group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continuous effort group</intervention_name>
    <description>Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Intensity used will be mild / moderate, ie 60% of the maximum load reached in the incremental test. The pedaling speed should be maintained between 30-60rpm. The execution time, from this exercise regime will be 20 minutes, and assessments at discharge.</description>
    <arm_group_label>Continuous effort group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients submitted to thoracic surgery with postero-lateral thoracotomy incision, as&#xD;
             well as those submitted to video-assisted thoracic surgery for pulmonary resection&#xD;
             (bulectomy, segmentectomy, lobectomy, pneumectomy);&#xD;
&#xD;
          -  Subjects extubated;&#xD;
&#xD;
          -  Hemodynamically stable (mean arterial pressure (MAP) between 60 mmHg and 100 mmHg,&#xD;
             heart rate (HR) between 50 bpm and 110 bpm&#xD;
&#xD;
          -  Peripheral oxygen saturation ≥ 90%;&#xD;
&#xD;
          -  With prescription for respiratory and motor physiotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are not extubated for up to 6 hours in the immediate postoperative&#xD;
             period, who require a second procedure during the immediate postoperative period;&#xD;
&#xD;
          -  Alterations in cognitive function;&#xD;
&#xD;
          -  Severe and decompensated cardiac arrhythmias;&#xD;
&#xD;
          -  Hypotensive crisis;&#xD;
&#xD;
          -  Hemoptysis;&#xD;
&#xD;
          -  Chest bleeding requiring reintervention;&#xD;
&#xD;
          -  sepsis;&#xD;
&#xD;
          -  Need for reintubation;&#xD;
&#xD;
          -  Signs of ventilatory effort;&#xD;
&#xD;
          -  Acute renal failure;&#xD;
&#xD;
          -  Unstable angina or malignant arrhythmias;&#xD;
&#xD;
          -  Fever.&#xD;
&#xD;
          -  Fluid drainage greater than 300 ml in the first six hours&#xD;
&#xD;
          -  Or those who refuse to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Health Science of Porto Alegre</investigator_affiliation>
    <investigator_full_name>Fabrício Edler Macagnan</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Thoracic Surgery</keyword>
  <keyword>Postoperative Period</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Early mobilization</keyword>
  <keyword>Cycle-ergometer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03229070
org study id: Cycle-ergometer- PTS 2017
nct id: NCT03229070
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-lateral thoracotomies and assisted thoracic surgery (CTVA) are the main surgical
      approaches for pulmonary resections. One of the counterpoints of these surgical approaches is
      postoperative pain, which in addition to causing ventilatory changes and reduction of lung
      capacities, contributes to bed rest and consequent decrease in patients' functionality. These
      complications increase hospitalization time and hospital costs, being determinant factors for
      perioperative morbidity and mortality. In order to prevent these outcomes of reduce the
      functional capacity of patients, new physiotherapeutic approaches have been adopted, such as
      the use of the cycloergometer. Recent studies show that the early use of this device brings
      benefits such as: improved blood circulation and venous return, increased muscle strength,
      improved functional capacity and reduced symptoms of dyspnea and fatigue. This study aims to
      compare the effect of interval training with continuous cycle ergometer training on
      performance in the six-minute walk test. Randomized and controlled clinical trial performed
      with patients submitted to elective thoracic surgery, hospitalized at the intensive care unit
      (ICU) and in the hospitalization unit of the Hospital Pavilhão Pereira Filho of the Santa
      Casa de Misericórdia Brotherhood of Porto Alegre. Participants will be randomized into three
      groups: control group (CG), interval exercise group (GHG) and continuous exercise group
      (GEC). Functional capacity assessments will be performed through the six-minute walk test
      (6MWT) and the chair sit and lift (TSL) test in 30 seconds, and evaluation of the clinical
      state of fatigue through the revised Piper-Fatigue Scale. The evaluations will be performed
      preoperatively and at hospital discharge.
Will include patients between 30 and 80 years of age, of both sexes, submitted to thoracic
      surgery with incision by posterolateral thoracotomy, as well as those submitted to
      video-assisted thoracic surgery for pulmonary resection (bulectomy, segmentectomy, lobectomy,
      pneumectomy).

      The cycloergometer rehabilitation program will be performed twice a day for 20 minutes.

      The expectation of comparing two different types of muscle overload (interval training versus
      continuous training) is that the training of shorter duration and greater load also has a
      greater demand on the cardiopulmonary system of these patients and, therefore, a better
      response to the functional capacity rehabilitation program of these individuals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum distance performed on six-minute test
time frame: 6 minutes
description: Walk in a 30m corridor
measure: Maximum number of times you succeed lift and sit on the chair
time frame: 30 seconds
description: With your arms crossed against your chest, sit up and get up from the chair
arm group label: Control Group
arm group type: No Intervention
description: Control Group: Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) and assessments at discharge
arm group label: Interval effort group
arm group type: Experimental
description: Interval effort group: Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Active phase (high load) lasting 60 seconds, followed by an active recovery phase with light / moderate load (60% of the maximum load) lasting 4 minutes. The pedaling speed should be maintained between 30-60rpm. There will be 5 cycles that will total 20 minutes of physical effort, and assessments at discharge.
arm group label: Continuous effort group
arm group type: Experimental
description: Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Intensity used will be mild / moderate, ie 60% of the maximum load reached in the incremental test. The pedaling speed should be maintained between 30-60rpm. The execution time, from this exercise regime will be 20 minutes, and assessments at discharge.
intervention type: Other
intervention name: Interval effort group
description: Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Active phase (high load) lasting 60 seconds, followed by an active recovery phase with light / moderate load (60% of the maximum load) lasting 4 minutes. The pedaling speed should be maintained between 30-60rpm. There will be 5 cycles that will total 20 minutes of physical effort, and assessments at discharge.
arm group label: Interval effort group
intervention type: Other
intervention name: Continuous effort group
description: Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Intensity used will be mild / moderate, ie 60% of the maximum load reached in the incremental test. The pedaling speed should be maintained between 30-60rpm. The execution time, from this exercise regime will be 20 minutes, and assessments at discharge.
arm group label: Continuous effort group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Federal University of Health Science of Porto Alegre
investigator full name: Fabrício Edler Macagnan
investigator title: PhD
mesh term: Dyspnea
sharing ipd: No