<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/NCT01693172</url>
  </required_header>
  <id_info>
    <org_study_id>118/12</org_study_id>
    <nct_id>NCT01693172</nct_id>
  </id_info>
  <brief_title>Effect of an Early Mobilization Program on Outcomes After Major Cancer Surgery</brief_title>
  <official_title>Effect of an Early Mobilization Program After Surgery on Functional Recovery and Clinical Complications in Patients Undergoing Major Cancer Surgey : a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto do Cancer do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto do Cancer do Estado de São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the effect of an early postoperative physical&#xD;
      rehabilitation program on the functional capacity and incidence of postoperative&#xD;
      complications in patients undergoing major elective surgery for treatment of a neoplasm&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">January 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ability to walk three meters or crossing a room without assistence</measure>
    <time_frame>at 5 days after surgery or at hospital discharge</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>fatigue</measure>
    <time_frame>at 5 and 30 days after surgery</time_frame>
    <description>We will assess the level of fatigue through the Piper fatigue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 5, 30, 180 and 365 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>at hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence of cancer</measure>
    <time_frame>at 180 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital costs</measure>
    <time_frame>at 180 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post operatorative complications</measure>
    <time_frame>at 30 days after surgery</time_frame>
    <description>Clavien classification</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Neoplasm</condition>
  <arm_group>
    <arm_group_label>early postoperative mobilization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Early postoperative supervised aerobic exercise, resistance and flexibility training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard rehabilitation care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Early mobilization program</intervention_name>
    <description>Early postoperative supervised aerobic exercise, resistance and flexibility training</description>
    <arm_group_label>early postoperative mobilization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who will be submitted to major surgery for cancer treatment.&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Reading and signing the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Acute myocardial infarction (within the last 30 days)&#xD;
&#xD;
          -  Unstable Angina&#xD;
&#xD;
          -  Cardiac arrhythmia uncontrolled&#xD;
&#xD;
          -  symptomatic severe aortic stenosis&#xD;
&#xD;
          -  Congestive heart failure NYHA III or IV&#xD;
&#xD;
          -  infarction or acute pulmonary thromboembolism&#xD;
&#xD;
          -  pericarditis or myocarditis&#xD;
&#xD;
          -  Acute Endocarditis&#xD;
&#xD;
          -  Acute aortic dissection&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Acute renal failure&#xD;
&#xD;
          -  Thyrotoxicosis&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  Inability to ambulate independently and / or inability to exercises&#xD;
&#xD;
          -  Presence of bone metastasis&#xD;
&#xD;
          -  musculoskeletal and neurological conditions that preclude the achievement of an&#xD;
             exercise program designed for this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ludhmila A Hajjar, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto do Câncer do Estado de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>01246000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elisângela PM Almeida, MD</last_name>
      <phone>551138932000</phone>
      <email>elismarinho@usp.br</email>
    </contact>
    <investigator>
      <last_name>Elisângela PM Almeida, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>August 27, 2015</last_update_submitted>
  <last_update_submitted_qc>August 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto do Cancer do Estado de São Paulo</investigator_affiliation>
    <investigator_full_name>Elisangela P M de Almeida, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>neoplasm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT01693172
org study id: 118/12
nct id: NCT01693172
lead sponsor: 
has dmc: No
The aim of this study is to evaluate the effect of an early postoperative physical
      rehabilitation program on the functional capacity and incidence of postoperative
      complications in patients undergoing major elective surgery for treatment of a neoplasm
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Ability to walk three meters or crossing a room without assistence
time frame: at 5 days after surgery or at hospital discharge
measure: fatigue
time frame: at 5 and 30 days after surgery
description: We will assess the level of fatigue through the Piper fatigue scale
measure: quality of life
time frame: at 5, 30, 180 and 365 days after surgery
measure: length of hospital stay
time frame: at hospital discharge
measure: recurrence of cancer
time frame: at 180 days after surgery
measure: hospital costs
time frame: at 180 days after surgery
measure: post operatorative complications
time frame: at 30 days after surgery
description: Clavien classification
arm group label: early postoperative mobilization
arm group type: Active Comparator
description: Early postoperative supervised aerobic exercise, resistance and flexibility training
arm group label: Standard
arm group type: No Intervention
description: Standard rehabilitation care
intervention type: Behavioral
intervention name: Early mobilization program
description: Early postoperative supervised aerobic exercise, resistance and flexibility training
arm group label: early postoperative mobilization
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ludhmila A Hajjar, MD, PhD
role: Principal Investigator
affiliation: University of Sao Paulo
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Instituto do Cancer do Estado de São Paulo
investigator full name: Elisangela P M de Almeida, MD
investigator title: Principal Investigator
mesh term: Neoplasms