<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/NCT03010033</url>
  </required_header>
  <id_info>
    <org_study_id>RTS-001</org_study_id>
    <nct_id>NCT03010033</nct_id>
  </id_info>
  <brief_title>Effect of Pulmonary Rehabilitation on Perioperative Outcomes in Smoker Patients With Lung Cancer</brief_title>
  <acronym>PREPOSE</acronym>
  <official_title>Effects of Pulmonary Rehabilitation and Airway Management on Short-term and Long-term Perioperative Results of Lobectomy in Smoker Patients With Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruijin Hospital</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>
      It is reported that smoker patients (&gt;400 cigarette/year) will suffer more postoperative&#xD;
      complications than non-smoker patients after lobectomy. Evidences has suggested pulmonary&#xD;
      rehabilitation could reduce the pulmonary complications after thoracic surgery. However, the&#xD;
      effect and long-term results of pulmonary rehabilitation on smoker patients have not been&#xD;
      studied. The purpose of this study is to determine whether pulmonary rehabilitation is&#xD;
      effective to smoker patients who underwent lobectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In China, the smoker population is about 300 hundred million. Tobacco has become one of the&#xD;
      world's public health problem. 30 percent of global surgery patients have smoking history. It&#xD;
      is reported that smoker patients (&gt;400 cigarette/year) will suffer more postoperative&#xD;
      complications than non-smoker patients after lobectomy (38.2% vs 12.5%). Smoking is an&#xD;
      independent risk factor of postoperative complications of cardiothoracic surgery. Evidences&#xD;
      showed that smoking had a negative effect on airway management which plays an important role&#xD;
      in postoperative recovery for thoracic surgery. Therefore, we hypothesise that&#xD;
      intervention-related study to find a way to reduce postoperative complications for smoker&#xD;
      patients is significantly meaningful in improving the overall outcome after pulmonary surgery&#xD;
      as 80 percent of patients with lung cancer are smoker in China. Recently, a series of&#xD;
      strategies on airway management have been proposed by clinical doctors. As one of the&#xD;
      important parts of airway management, pulmonary rehabilitation has been demonstrated by&#xD;
      evidence-base medicine to reduce the pulmonary complications after thoracic surgery and&#xD;
      increase the breathing capacity. According to the reported literatures, the effect and&#xD;
      long-term results of pulmonary rehabilitation on smoker patients have not been studied, so we&#xD;
      designed this randomized controlled trial to determine whether pulmonary rehabilitation would&#xD;
      be effective to smoker patients who underwent lobectomy which was associated with significant&#xD;
      loss of lung function.&#xD;
&#xD;
      According to the reported papers in China, main observation index in experimental group was&#xD;
      about 25.7, and in control group was about 10%. At the level of α=0.05 (Bilateral), power of&#xD;
      test (1-β)=0.80, ratio=1:1. The estimated minimum required sample size of each group was 93&#xD;
      cases, the statistical loss rate was set as 10%. The overall sample size of this study was&#xD;
      about 200 cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 20, 2017</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2022</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pulmonary complications</measure>
    <time_frame>postoperative in-hospital stay up to 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of stay (LOS)</measure>
    <time_frame>postoperative in-hospital stay up to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>therapeutic time of antibiotics</measure>
    <time_frame>Postoperative in-hospital stay up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial blood gas analysis</measure>
    <time_frame>before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vital signs</measure>
    <time_frame>before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain score of expectoration</measure>
    <time_frame>1 day and 3 days after surgery</time_frame>
    <description>Visual Analogue Scale (VAS) Pain Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of expectoration drainage</measure>
    <time_frame>postoperative in-hospital stay up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peak expiratory flow</measure>
    <time_frame>before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lung function test</measure>
    <time_frame>before treatment, 3 days after surgery, 3 months after surgery, 6 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total hospitalization expenditures</measure>
    <time_frame>postoperative in-hospital stay up to 30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pulmonary Neoplasm</condition>
  <arm_group>
    <arm_group_label>regular care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>[Control group] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary and regular rehabilitation-propaganda; postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time) and early ambulation unless serious patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pulmonary rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[Study group] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary, regular rehabilitation-propaganda and interventional pulmonary rehabilitation (preoperative part); postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time), early ambulation unless serious patients and interventional pulmonary rehabilitation (postoperative part).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pulmonary rehabilitation</intervention_name>
    <description>pulmonary rehabilitation (preoperative part): lower extremity endurance training (using bike ergometer for 3 days, 2 times/day, 15-20min/time) or stair climbing training (3 days, 2 times/day, 30min/time), keep dyspnea index (Borg) score between 5 to 7 points. And inspiratory muscle training (using threshold inspiratory muscle trainer for 3 days, 5 times/day, 2 sessions/time, every session includes 10-20 cycle respirations).&#xD;
pulmonary rehabilitation (postoperative part): inspiratory muscle training (using threshold inspiratory muscle trainer until hospital discharge, 3-5 times/day, 1 session/time, every session includes 10-20 cycle respirations).</description>
    <arm_group_label>pulmonary rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. signed consent&#xD;
&#xD;
          2. smoker, ≥400/cigarette year&#xD;
&#xD;
          3. surgical approach: open or Video-assisted Thoracoscopic Surgery (VATS) lobectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serious physical diseases in patients during hospitalization, such as severe heart and&#xD;
             lung diseases (CLASS III-IV) (FEV1/FVC &lt;0.7and FEV1 &lt;50% predicted value), kidney&#xD;
             disease (ESRD change need to continue dialysis), or liver diseases (cirrhosis of the&#xD;
             liver accompanied by ascites)&#xD;
&#xD;
          2. unable to obey interventional instructions/treatments because of any reasons&#xD;
&#xD;
          3. stage IV lung cancer&#xD;
&#xD;
          4. emergency surgery&#xD;
&#xD;
          5. lung cancer with preoperative chemotherapy, radiotherapy or chemoradiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>He-Cheng Li, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ding-Pei Han, master</last_name>
    <phone>00862164370045</phone>
    <phone_ext>666112</phone_ext>
    <email>dmhan1985@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>He-Cheng Li, doctor</last_name>
    <phone>00862164370045</phone>
    <phone_ext>666112</phone_ext>
    <email>lihecheng2000@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai JiaoTong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ding-Pei Han, master</last_name>
      <phone>00862164370045</phone>
      <phone_ext>666112</phone_ext>
      <email>dmhan1985@163.com</email>
    </contact>
    <contact_backup>
      <last_name>He-Cheng Li, doctor</last_name>
      <phone>00862164370045</phone>
      <phone_ext>666112</phone_ext>
      <email>lihecheng2000@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ding-Pei Han, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Run-Sen Jin, doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ya-Jie Zhang, doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jie Xiang, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kai Chen, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hai-Lei Du, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jia-Ming Che, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jun-Biao Hang, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Liang-Gang Zhu, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xiao-Qing Yang, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xiang Zhou, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jian Ren, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>January 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>Hecheng Li M.D., Ph.D</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>pulmonary rehabilitation</keyword>
  <keyword>lobectomy</keyword>
  <keyword>smoker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung 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/NCT03010033
org study id: RTS-001
nct id: NCT03010033
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is reported that smoker patients (>400 cigarette/year) will suffer more postoperative
      complications than non-smoker patients after lobectomy. Evidences has suggested pulmonary
      rehabilitation could reduce the pulmonary complications after thoracic surgery. However, the
      effect and long-term results of pulmonary rehabilitation on smoker patients have not been
      studied. The purpose of this study is to determine whether pulmonary rehabilitation is
      effective to smoker patients who underwent lobectomy.
In China, the smoker population is about 300 hundred million. Tobacco has become one of the
      world's public health problem. 30 percent of global surgery patients have smoking history. It
      is reported that smoker patients (>400 cigarette/year) will suffer more postoperative
      complications than non-smoker patients after lobectomy (38.2% vs 12.5%). Smoking is an
      independent risk factor of postoperative complications of cardiothoracic surgery. Evidences
      showed that smoking had a negative effect on airway management which plays an important role
      in postoperative recovery for thoracic surgery. Therefore, we hypothesise that
      intervention-related study to find a way to reduce postoperative complications for smoker
      patients is significantly meaningful in improving the overall outcome after pulmonary surgery
      as 80 percent of patients with lung cancer are smoker in China. Recently, a series of
      strategies on airway management have been proposed by clinical doctors. As one of the
      important parts of airway management, pulmonary rehabilitation has been demonstrated by
      evidence-base medicine to reduce the pulmonary complications after thoracic surgery and
      increase the breathing capacity. According to the reported literatures, the effect and
      long-term results of pulmonary rehabilitation on smoker patients have not been studied, so we
      designed this randomized controlled trial to determine whether pulmonary rehabilitation would
      be effective to smoker patients who underwent lobectomy which was associated with significant
      loss of lung function.

      According to the reported papers in China, main observation index in experimental group was
      about 25.7, and in control group was about 10%. At the level of α=0.05 (Bilateral), power of
      test (1-β)=0.80, ratio=1:1. The estimated minimum required sample size of each group was 93
      cases, the statistical loss rate was set as 10%. The overall sample size of this study was
      about 200 cases.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: postoperative pulmonary complications
time frame: postoperative in-hospital stay up to 30 days
measure: length of stay (LOS)
time frame: postoperative in-hospital stay up to 90 days
measure: therapeutic time of antibiotics
time frame: Postoperative in-hospital stay up to 30 days
measure: arterial blood gas analysis
time frame: before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
measure: vital signs
time frame: before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
measure: pain score of expectoration
time frame: 1 day and 3 days after surgery
description: Visual Analogue Scale (VAS) Pain Score
measure: amount of expectoration drainage
time frame: postoperative in-hospital stay up to 30 days
measure: peak expiratory flow
time frame: before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
measure: lung function test
time frame: before treatment, 3 days after surgery, 3 months after surgery, 6 months after surgery
measure: total hospitalization expenditures
time frame: postoperative in-hospital stay up to 30 days
arm group label: regular care
arm group type: No Intervention
description: [Control group] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary and regular rehabilitation-propaganda; postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time) and early ambulation unless serious patients.
arm group label: pulmonary rehabilitation
arm group type: Experimental
description: [Study group] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary, regular rehabilitation-propaganda and interventional pulmonary rehabilitation (preoperative part); postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time), early ambulation unless serious patients and interventional pulmonary rehabilitation (postoperative part).
intervention type: Other
intervention name: pulmonary rehabilitation
description: pulmonary rehabilitation (preoperative part): lower extremity endurance training (using bike ergometer for 3 days, 2 times/day, 15-20min/time) or stair climbing training (3 days, 2 times/day, 30min/time), keep dyspnea index (Borg) score between 5 to 7 points. And inspiratory muscle training (using threshold inspiratory muscle trainer for 3 days, 5 times/day, 2 sessions/time, every session includes 10-20 cycle respirations).
pulmonary rehabilitation (postoperative part): inspiratory muscle training (using threshold inspiratory muscle trainer until hospital discharge, 3-5 times/day, 1 session/time, every session includes 10-20 cycle respirations).
arm group label: pulmonary rehabilitation
criteria: 
gender: All
minimum age: N/A
maximum age: 80 Years
healthy volunteers: No
last name: He-Cheng Li, doctor
role: Principal Investigator
affiliation: Ruijin Hospital
last name: Ding-Pei Han, master
phone: 00862164370045
phone ext: 666112
email: dmhan1985@163.com
last name: He-Cheng Li, doctor
phone: 00862164370045
phone ext: 666112
email: lihecheng2000@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: Hecheng Li M.D., Ph.D
investigator title: Professor
mesh term: Lung Neoplasms