xml: <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/NCT05969678</url>
    </required_header>
    <id_info>
      <org_study_id>202304111RINC</org_study_id>
      <nct_id>NCT05969678</nct_id>
    </id_info>
    <brief_title>Respiratory Training Intervention</brief_title>
    <official_title>Effects of Respiratory Training Intervention on Lung Capacity and Quality of Life of Community Elderly</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chung Shan Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chung Shan Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to examine the effect of abdominal diaphragmatic breathing combined with&#xD;
        incentive spirometer breathing training on the lung capacity of elderly community residents.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research will be conducted in a community in central Taiwan. Inclusion criteria are&#xD;
        people over the age of 65 in the community. All participants will be randomly assigned to&#xD;
        either the experimental group or the control group. The experimental group will receive the&#xD;
        breathing training of abdominal diaphragmatic breathing method combined with incentive&#xD;
        spiromete. The control group is only taught the breathing training of abdominal diaphragmatic&#xD;
        breathing. Four assessment tools will be used, including the demographic questionnaire,&#xD;
        respiratory capacity indicators, Modified Medical Research Council (mMRC) Dyspnea Scale, and&#xD;
        the World Health Organization Quality of Life-BREF Taiwan Version (WHOQOL-BREF; WHOQOL-BREF).&#xD;
        Data analysis will be performed by independent sample t test, paired t test, and repeated&#xD;
        measures analysis. All data analysis will be performed by SPSS version 22.0.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 13, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 13, 2024</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>Parallel Assignment</intervention_model>
      <intervention_model_description>The experimental group will receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete. The control group is only taught the breathing training of abdominal diaphragmatic breathing.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>respiratory capacity indicators</measure>
      <time_frame>The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.</time_frame>
      <description>Indicator: FVC (forced vital capacity) ,FEV1(forced expiratory volume),MVV (maximal voluntary ventilation).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dyspnea</measure>
      <time_frame>The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.</time_frame>
      <description>Modified Medical Research Council (mMRC) Dyspnea Scale) will be used to assess participants' breathing condition. This scale consisting of five items containing statements about the impact of breathlessness on the individual . It ranges from grade 0 to 4. Higher scores reflect lower respiratory function condition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of Life (OL)</measure>
      <time_frame>The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.</time_frame>
      <description>The 28 items World Health Organization Quality of Life-BREF Taiwan Version (WHOQOL-BREF)WHOQOL-BREF) will be used to examine participants' quality of life. Each item is rated on a 5-point Likert-type scale ranging from 1 (not at all) to 4 (very agree). The total score is the sum of all item scores. Higher scores reflect greater quality of life.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Elders</condition>
    <arm_group>
      <arm_group_label>Intervention group ( breathing training with incentive spiromete)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group will receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group is only taught the breathing training of abdominal diaphragmatic breathing.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>breathing training</intervention_name>
      <description>receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete</description>
      <arm_group_label>Intervention group ( breathing training with incentive spiromete)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Over 65 years old&#xD;
  &#xD;
            2. A person who is conscious and can communicate in Mandarin or Hokkien, and can&#xD;
               cooperate with breathing exercises.&#xD;
  &#xD;
            3. Agree to interview or fill out the questionnaire, and complete the consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Hemoptysis, pneumothorax, unstable cardiovascular status, chronic respiratory diseases&#xD;
               (asthma, chronic obstructive pulmonary disease).&#xD;
  &#xD;
            2. Recent myocardial infarction or pulmonary embolism, thoracic aortic aneurysm,&#xD;
               abdominal aortic aneurysm or cerebral aneurysm, recent eye surgery, nausea or&#xD;
               vomiting, recent chest or abdominal surgery.&#xD;
  &#xD;
            3. Suffering from infectious diseases: airborne such as: chickenpox, measles,&#xD;
               tuberculosis, severe special infectious pneumonia influenza. Droplet transmission such&#xD;
               as: pneumonia, influenza.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hsiang Chu Pai, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Chung Shan Medical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Chung Shan Medical University</name>
        <address>
          <city>Taichung</city>
          <zip>40201</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chung Shan Medical University</investigator_affiliation>
      <investigator_full_name>Hsiang Chu Pai</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>breathing training</keyword>
    <keyword>abdominal diaphragmatic breathing</keyword>
    <keyword>respiratory capacity</keyword>
    <keyword>Quality of Life-</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969678
  org study id: 202304111RINC
  nct id: NCT05969678
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to examine the effect of abdominal diaphragmatic breathing combined with
        incentive spirometer breathing training on the lung capacity of elderly community residents.
  The research will be conducted in a community in central Taiwan. Inclusion criteria are
        people over the age of 65 in the community. All participants will be randomly assigned to
        either the experimental group or the control group. The experimental group will receive the
        breathing training of abdominal diaphragmatic breathing method combined with incentive
        spiromete. The control group is only taught the breathing training of abdominal diaphragmatic
        breathing. Four assessment tools will be used, including the demographic questionnaire,
        respiratory capacity indicators, Modified Medical Research Council (mMRC) Dyspnea Scale, and
        the World Health Organization Quality of Life-BREF Taiwan Version (WHOQOL-BREF; WHOQOL-BREF).
        Data analysis will be performed by independent sample t test, paired t test, and repeated
        measures analysis. All data analysis will be performed by SPSS version 22.0.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: The experimental group will receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete. The control group is only taught the breathing training of abdominal diaphragmatic breathing.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: respiratory capacity indicators
  time frame: The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.
  description: Indicator: FVC (forced vital capacity) ,FEV1(forced expiratory volume),MVV (maximal voluntary ventilation).
  measure: Dyspnea
  time frame: The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.
  description: Modified Medical Research Council (mMRC) Dyspnea Scale) will be used to assess participants' breathing condition. This scale consisting of five items containing statements about the impact of breathlessness on the individual . It ranges from grade 0 to 4. Higher scores reflect lower respiratory function condition.
  measure: Quality of Life (OL)
  time frame: The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.
  description: The 28 items World Health Organization Quality of Life-BREF Taiwan Version (WHOQOL-BREF)WHOQOL-BREF) will be used to examine participants' quality of life. Each item is rated on a 5-point Likert-type scale ranging from 1 (not at all) to 4 (very agree). The total score is the sum of all item scores. Higher scores reflect greater quality of life.
  arm group label: Intervention group ( breathing training with incentive spiromete)
  arm group type: Experimental
  description: The experimental group will receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete.
  arm group label: control group
  arm group type: No Intervention
  description: The control group is only taught the breathing training of abdominal diaphragmatic breathing.
  intervention type: Behavioral
  intervention name: breathing training
  description: receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete
  arm group label: Intervention group ( breathing training with incentive spiromete)
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hsiang Chu Pai, PhD
  role: Study Director
  affiliation: Chung Shan Medical University
  facility: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Chung Shan Medical University
  investigator full name: Hsiang Chu Pai
  investigator title: Principal Investigator
  sharing ipd: No