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/NCT06031675</url>
    </required_header>
    <id_info>
      <org_study_id>K0001</org_study_id>
      <nct_id>NCT06031675</nct_id>
    </id_info>
    <brief_title>Mechanism for Exercise to Delay Cardiac Aging</brief_title>
    <official_title>The αKlotho Protein-mediated NLRP3/Caspase-1/GSDMD Pathway Counteracts Myocardial Stunning: a Novel Mechanism for Exercise to Delay Cardiac Aging</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xiao-dong Zhuang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen University</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>
        The goal of this clinicaltrial is to assess and compare isokinetic performance, surface&#xD;
        electromyography, laboratory parameters, and cardiorespiratory function both before and after&#xD;
        engaging in vigorous intermittent lifestyle physical activity(VILPA) within a healthy&#xD;
        population.&#xD;
  &#xD;
        The main question it aims to answer is:&#xD;
  &#xD;
        [1] Does VILPA yield effective outcomes?&#xD;
  &#xD;
        Throughout the course of the trial, participants will engage in a simulated regimen of&#xD;
        vigorous intermittent lifestyle physical activity for a duration of 8 weeks. The efficacy of&#xD;
        the exercise protocol will be quantified and evaluated through the utilization of a wearable&#xD;
        device.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 12, 2023</start_date>
    <completion_date type="Actual">September 1, 2023</completion_date>
    <primary_completion_date type="Actual">July 10, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Isometric Strength Test</measure>
      <time_frame>15 minutes</time_frame>
      <description>Isokinetic muscle strength testing with the Isomed 2000</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Surface electromyography</measure>
      <time_frame>30 minutes</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Exercise Flat Test</measure>
      <time_frame>30 minutes</time_frame>
      <description>cardiopulmonary function</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fasting glucose</measure>
      <time_frame>5 minutes</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood lipid</measure>
      <time_frame>5 minutes</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">40</enrollment>
    <condition>Activity, Motor</condition>
    <condition>Health Behavior</condition>
    <arm_group>
      <arm_group_label>intervention group</arm_group_label>
      <description>The intervention measures encompass the implementation of simulated vigorous intermittent lifestyle physical activity for all participants. The specific exercise regimen involves performing rope jumping activities three times a day, with each session aimed at surpassing the exercise threshold (not conducted in a continuous manner), where the heart rate should exceed 160 beats per minute. This routine will be undertaken five times a week, continuously for a span of 8 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Vigorous intermittent lifestyle physical activity</intervention_name>
      <description>The specific exercise regimen involves performing rope jumping activities three times a day, with each session aimed at surpassing the exercise threshold (not conducted in a continuous manner), where the heart rate should exceed 160 beats per minute. This routine will be undertaken five times a week, continuously for a span of 8 weeks.</description>
      <arm_group_label>intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          University students&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy Adults&#xD;
  &#xD;
            2. No exercise habits (more than 3 months)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Exercising ≥ 3 times per week;&#xD;
  &#xD;
            2. the presence of chronic diseases, such as hypertension, hyperglycemic states, etc;&#xD;
  &#xD;
            3. have conducted an exercise program in the past three months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lizhen Liao, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Department of Health, Guangdong Pharmaceutical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Guangdong Pharmaceutical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510006</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Xiao-dong Zhuang</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>vigorous intermittent lifestyle physical activity</keyword>
    <keyword>wearable device</keyword>
    <keyword>isokinetic performance</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/NCT06031675
  org study id: K0001
  nct id: NCT06031675
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinicaltrial is to assess and compare isokinetic performance, surface
        electromyography, laboratory parameters, and cardiorespiratory function both before and after
        engaging in vigorous intermittent lifestyle physical activity(VILPA) within a healthy
        population.
  
        The main question it aims to answer is:
  
        [1] Does VILPA yield effective outcomes?
  
        Throughout the course of the trial, participants will engage in a simulated regimen of
        vigorous intermittent lifestyle physical activity for a duration of 8 weeks. The efficacy of
        the exercise protocol will be quantified and evaluated through the utilization of a wearable
        device.
  observational model: Cohort
  time perspective: Prospective
  measure: Isometric Strength Test
  time frame: 15 minutes
  description: Isokinetic muscle strength testing with the Isomed 2000
  measure: Surface electromyography
  time frame: 30 minutes
  measure: Exercise Flat Test
  time frame: 30 minutes
  description: cardiopulmonary function
  measure: Fasting glucose
  time frame: 5 minutes
  measure: Blood lipid
  time frame: 5 minutes
  arm group label: intervention group
  description: The intervention measures encompass the implementation of simulated vigorous intermittent lifestyle physical activity for all participants. The specific exercise regimen involves performing rope jumping activities three times a day, with each session aimed at surpassing the exercise threshold (not conducted in a continuous manner), where the heart rate should exceed 160 beats per minute. This routine will be undertaken five times a week, continuously for a span of 8 weeks.
  intervention type: Other
  intervention name: Vigorous intermittent lifestyle physical activity
  description: The specific exercise regimen involves performing rope jumping activities three times a day, with each session aimed at surpassing the exercise threshold (not conducted in a continuous manner), where the heart rate should exceed 160 beats per minute. This routine will be undertaken five times a week, continuously for a span of 8 weeks.
  arm group label: intervention group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lizhen Liao, PhD
  role: Study Director
  affiliation: Department of Health, Guangdong Pharmaceutical University
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Xiao-dong Zhuang
  investigator title: Clinical Professor
  sharing ipd: No