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/NCT05986448</url>
    </required_header>
    <id_info>
      <org_study_id>2022-35</org_study_id>
      <nct_id>NCT05986448</nct_id>
    </id_info>
    <brief_title>Effects of Tai Chi for Early Pulmonary Rehabilitation in Elderly Patients With AECOPD</brief_title>
    <official_title>Effects of Tai Chi for Early Pulmonary Rehabilitation in Elderly Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) and Malnutrition: a Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Houmei SHEN</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Anhui 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>
        The goal of this clinical trial is to learn about the therapeutic effect of Chinese&#xD;
        traditional exercise Tai Chi in elderly acute exacerbation of chronic obstructive pulmonary&#xD;
        disease (AECOPD) with malnutrition. The main questions it aims to answer are:&#xD;
  &#xD;
          1. Improvement of pulmonary function in patients with Tai Chi exercise;&#xD;
  &#xD;
          2. Improvement of pulmonary function in patients with Tai Chi exercise.&#xD;
  &#xD;
        The patients in control group were given routine nursing care model, including:&#xD;
  &#xD;
          1. Providing basic nursing care and protection for patients according to their needs,&#xD;
             paying attention to the care of patients' airways, and providing relevant protection and&#xD;
             auxiliary interventions according to the needs of patients when carrying out nebulized&#xD;
             inhalation interventions;&#xD;
  &#xD;
          2. Customized nutritional supplementation recipes by specialists in clinical nutrition,&#xD;
             giving high-protein and low-carbohydrate diets, and giving enteral or parenteral&#xD;
             nutritional support to those who have insufficient food intake through the mouth;&#xD;
  &#xD;
          3. Carrying out health education and psychological care to alleviate the patients'&#xD;
             psychological burdens.&#xD;
  &#xD;
        On the basis of the routine care model of the control group, a Tai Chi training program was&#xD;
        developed in Tai Chi group. Tai Chi training lasted for a total of 6 months, with 4 training&#xD;
        sessions scheduled per week, each session lasting about 40 minutes. Experts from Anqing Tai&#xD;
        Chi Association were invited to guide the training. The training program consists of a&#xD;
        5-minute pre-training warm-up, a 30-minute Tai Chi exercise, and a 5-minute post-training&#xD;
        stretching session. The Tai Chi training was done at a moderate intensity, with the heart&#xD;
        rate limited to 60%~80% of the maximal heart rate, where:&#xD;
  &#xD;
        maximal heart rate=220-age. Accelerometers were worn for each member to record heart rate&#xD;
        changes during training, and when the heart rate exceeded the standard range, the exercise&#xD;
        intensity could be adjusted to keep the heart rate within a reasonable range.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Actual">January 2, 2023</completion_date>
    <primary_completion_date type="Actual">January 1, 2023</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>BODE index</measure>
      <time_frame>Measurements of BODE index will be taken prior to the start of the trial and at 6 months after the start of the trial.</time_frame>
      <description>Body Mass Index (B), the degree of airflow obstruction (O), dyspnea (D), exercise capacity (E)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma total protein</measure>
      <time_frame>Measurements of plasma total protein will be taken prior to the start of the trial and at 6 months after the start of the trial.</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plasma albumin</measure>
      <time_frame>Measurements of plasma albumin will be taken prior to the start of the trial and at 6 months after the start of the trial.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma prealbumin</measure>
      <time_frame>Measurements of plasma prealbumin will be taken prior to the start of the trial and at 6 months after the start of the trial.</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">96</enrollment>
    <condition>Pulmonary Disease, Chronic Obstructive</condition>
    <arm_group>
      <arm_group_label>Tai-chi group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Basic care measures and Tai-chi exercise</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Basic care measures</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Tai-chi exercise</intervention_name>
      <description>Traditional Chinese Tai Chi Movement</description>
      <arm_group_label>Tai-chi group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ≥60 and ≤85 years of age;&#xD;
  &#xD;
            2. Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive&#xD;
               Lung Disease (GOLD) criteria;&#xD;
  &#xD;
            3. Patients admitted to the hospital for treatment of chronic, repetitive coughing and&#xD;
               severe dyspnea;&#xD;
  &#xD;
            4. NRS-2002 Nutritional Risk Screening Scale score ≧3, suggesting malnutrition;&#xD;
  &#xD;
            5. Conscious, able to perform normal verbal communication and without motor dysfunction&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. People with impaired consciousness or invasive mechanical ventilation who were unable&#xD;
               to fully understand and cooperate with the experiment;&#xD;
  &#xD;
            2. People with active tuberculosis, lung cancer, asthma and other diseases limiting&#xD;
               ventilation;&#xD;
  &#xD;
            3. People with impaired motor function;&#xD;
  &#xD;
            4. People with serious life-threatening diseases of other systems and malignant tumors;&#xD;
  &#xD;
            5. People with heart failure (NYHA stage IV).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Anqing Hospital Affiliated to Anhui Medical University</name>
        <address>
          <city>Anqing</city>
          <state>Anhui</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Anhui Medical University</investigator_affiliation>
      <investigator_full_name>Houmei SHEN</investigator_full_name>
      <investigator_title>Senior nursing officer, Department of Emergency Medicine, Anqing Hospital Affiliated to Anhui Medical University, China</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    </condition_browse>
    <!-- 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/NCT05986448
  org study id: 2022-35
  nct id: NCT05986448
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about the therapeutic effect of Chinese
        traditional exercise Tai Chi in elderly acute exacerbation of chronic obstructive pulmonary
        disease (AECOPD) with malnutrition. The main questions it aims to answer are:
  
          1. Improvement of pulmonary function in patients with Tai Chi exercise;
  
          2. Improvement of pulmonary function in patients with Tai Chi exercise.
  
        The patients in control group were given routine nursing care model, including:
  
          1. Providing basic nursing care and protection for patients according to their needs,
             paying attention to the care of patients' airways, and providing relevant protection and
             auxiliary interventions according to the needs of patients when carrying out nebulized
             inhalation interventions;
  
          2. Customized nutritional supplementation recipes by specialists in clinical nutrition,
             giving high-protein and low-carbohydrate diets, and giving enteral or parenteral
             nutritional support to those who have insufficient food intake through the mouth;
  
          3. Carrying out health education and psychological care to alleviate the patients'
             psychological burdens.
  
        On the basis of the routine care model of the control group, a Tai Chi training program was
        developed in Tai Chi group. Tai Chi training lasted for a total of 6 months, with 4 training
        sessions scheduled per week, each session lasting about 40 minutes. Experts from Anqing Tai
        Chi Association were invited to guide the training. The training program consists of a
        5-minute pre-training warm-up, a 30-minute Tai Chi exercise, and a 5-minute post-training
        stretching session. The Tai Chi training was done at a moderate intensity, with the heart
        rate limited to 60%~80% of the maximal heart rate, where:
  
        maximal heart rate=220-age. Accelerometers were worn for each member to record heart rate
        changes during training, and when the heart rate exceeded the standard range, the exercise
        intensity could be adjusted to keep the heart rate within a reasonable range.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: BODE index
  time frame: Measurements of BODE index will be taken prior to the start of the trial and at 6 months after the start of the trial.
  description: Body Mass Index (B), the degree of airflow obstruction (O), dyspnea (D), exercise capacity (E)
  measure: Plasma total protein
  time frame: Measurements of plasma total protein will be taken prior to the start of the trial and at 6 months after the start of the trial.
  measure: Plasma albumin
  time frame: Measurements of plasma albumin will be taken prior to the start of the trial and at 6 months after the start of the trial.
  measure: Plasma prealbumin
  time frame: Measurements of plasma prealbumin will be taken prior to the start of the trial and at 6 months after the start of the trial.
  arm group label: Tai-chi group
  arm group type: Experimental
  description: Basic care measures and Tai-chi exercise
  arm group label: control group
  arm group type: No Intervention
  description: Basic care measures
  intervention type: Behavioral
  intervention name: Tai-chi exercise
  description: Traditional Chinese Tai Chi Movement
  arm group label: Tai-chi group
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 85 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Anhui Medical University
  investigator full name: Houmei SHEN
  investigator title: Senior nursing officer, Department of Emergency Medicine, Anqing Hospital Affiliated to Anhui Medical University, China
  mesh term: Lung Diseases
  mesh term: Pulmonary Disease, Chronic Obstructive