<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/NCT03767140</url>
  </required_header>
  <id_info>
    <org_study_id>acupuncture</org_study_id>
    <nct_id>NCT03767140</nct_id>
  </id_info>
  <brief_title>Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD</brief_title>
  <official_title>Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD Controlled, Randomized, Double Blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Ciências Biomédicas Abel Salazar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Ciências Biomédicas Abel Salazar</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Chronic Obstructive Pulmonary Disease (COPD) is nowadays the 4th cause of death in the world&#xD;
      and it´s expected to become the 3rd cause of death in 2020 and the majority cause of&#xD;
      morbidity. Besides that, in Portugal COPD patients become more dependents each day.&#xD;
&#xD;
      Acupuncture as a reflex therapy it´s carried out through a Traditional Chinese Medicine (TCM)&#xD;
      diagnose that will allowed to identify the acupoints.&#xD;
&#xD;
      The investigators are interested in to assess acupuncture efficacy on physical exercise&#xD;
      tolerance in COPD patients.An experimental, controlled, randomized, double blind study was&#xD;
      done. Patients were recruited according TCM diagnose to optimize potential therapeutic&#xD;
      effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2018</start_date>
  <completion_date type="Actual">November 28, 2018</completion_date>
  <primary_completion_date type="Actual">September 25, 2018</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>
    <intervention_model_description>The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture.&#xD;
The method used to randomized was flipping a coin, when got heads they went to verum group and when got tails they went to sham group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Patients didn´t know what kind of therapy they were submitted The acupuncturist was a nurse, able to do invasive procedures with no knowledge of Chinese Medicine, and totally blind in terms of the verum or sham acupuncture.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>six minute walk test (6MWT)</measure>
    <time_frame>6 minutes</time_frame>
    <description>distance walked (metres)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen peripheral saturation (SPO2)</measure>
    <time_frame>6 minutes</time_frame>
    <description>pulse oximeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rating of perceived exertion (Borg Scale)</measure>
    <time_frame>6 minutes</time_frame>
    <description>during 6MWT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>6 minutes</time_frame>
    <description>measure at end of 6MWT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>6 minutes</time_frame>
    <description>at end of 6MWT</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Verum acupucnture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Real acupuncture treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>False acupuncture treatment using not acupuncture points</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture</description>
    <arm_group_label>Verum acupucnture</arm_group_label>
    <arm_group_label>sham acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD GOLD III,IV;&#xD;
&#xD;
          -  able to walk;&#xD;
&#xD;
          -  Informed consent signed;&#xD;
&#xD;
          -  stable medication during last 3 days&#xD;
&#xD;
          -  exacerbation during 3 months;&#xD;
&#xD;
          -  Chinese diagnose opening principle;&#xD;
&#xD;
          -  blood pressure &quot;90&quot;180 mmhg/ &quot;100mmhg; respiratory rate &quot;10&quot;30 cpm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoker;&#xD;
&#xD;
          -  metastasis;&#xD;
&#xD;
          -  hepatic,&#xD;
&#xD;
          -  renal or cardiovascular disease;&#xD;
&#xD;
          -  pulmonary hypertension;&#xD;
&#xD;
          -  COPD symptoms exacerbation during the therapy;&#xD;
&#xD;
          -  previous acupuncture treatments;&#xD;
&#xD;
          -  unstable vital signs;&#xD;
&#xD;
          -  pulmonary rehabilitation in the last 6 months;&#xD;
&#xD;
          -  needle phobia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henry Greten, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Abel Salazar Institute of Biomedical Sciences, University of Porto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carla Manuela Loureiro Barros</name>
      <address>
        <city>Marco de Canaveses</city>
        <state>Porto</state>
        <zip>4635 670</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto de Ciências Biomédicas Abel Salazar</investigator_affiliation>
    <investigator_full_name>Carla Manuela Loureiro Barros</investigator_full_name>
    <investigator_title>Master student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT03767140
org study id: acupuncture
nct id: NCT03767140
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Chronic Obstructive Pulmonary Disease (COPD) is nowadays the 4th cause of death in the world
      and it´s expected to become the 3rd cause of death in 2020 and the majority cause of
      morbidity. Besides that, in Portugal COPD patients become more dependents each day.

      Acupuncture as a reflex therapy it´s carried out through a Traditional Chinese Medicine (TCM)
      diagnose that will allowed to identify the acupoints.

      The investigators are interested in to assess acupuncture efficacy on physical exercise
      tolerance in COPD patients.An experimental, controlled, randomized, double blind study was
      done. Patients were recruited according TCM diagnose to optimize potential therapeutic
      effects.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture.
The method used to randomized was flipping a coin, when got heads they went to verum group and when got tails they went to sham group.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Patients didn´t know what kind of therapy they were submitted The acupuncturist was a nurse, able to do invasive procedures with no knowledge of Chinese Medicine, and totally blind in terms of the verum or sham acupuncture.
measure: six minute walk test (6MWT)
time frame: 6 minutes
description: distance walked (metres)
measure: Oxygen peripheral saturation (SPO2)
time frame: 6 minutes
description: pulse oximeter
measure: Rating of perceived exertion (Borg Scale)
time frame: 6 minutes
description: during 6MWT
measure: Blood pressure
time frame: 6 minutes
description: measure at end of 6MWT
measure: heart rate
time frame: 6 minutes
description: at end of 6MWT
arm group label: Verum acupucnture
arm group type: Experimental
description: Real acupuncture treatment
arm group label: sham acupuncture
arm group type: Sham Comparator
description: False acupuncture treatment using not acupuncture points
intervention type: Procedure
intervention name: acupuncture
description: The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture
arm group label: Verum acupucnture
arm group label: sham acupuncture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Henry Greten, Doctor
role: Study Chair
affiliation: Abel Salazar Institute of Biomedical Sciences, University of Porto
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Instituto de Ciências Biomédicas Abel Salazar
investigator full name: Carla Manuela Loureiro Barros
investigator title: Master student
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No