<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/NCT03275038</url>
  </required_header>
  <id_info>
    <org_study_id>201612213RINB</org_study_id>
    <nct_id>NCT03275038</nct_id>
  </id_info>
  <brief_title>Comparing Effects and Neural Mechanisms of Tai Chi and Light-to-Moderate Intensity Aerobic Exercises</brief_title>
  <official_title>Comparing Effects and Neural Mechanisms of Tai Chi and Light-to-Moderate Intensity on the Prevention of Leukoaraiosis and Declines in Brain, Physical, and Psychological Functions in Middle-aged and Older Adults With Cardiovascular Risks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      In this three-year project, investigators will target on sedentary middle-aged and older&#xD;
      adults with cardiovascular risks, prescribe 24-week Tai Chi or aerobic exercises and examine:&#xD;
&#xD;
        1. Whether both exercises are effective to reduce cardiovascular risks, prevent&#xD;
           leukoaraiosis and associated declines in physical and psychological functions at Week 12&#xD;
           and 24;&#xD;
&#xD;
        2. Will Tai Chi exercises be more effective on improving psychological health (cognition,&#xD;
           psychological well-being, and exercise self-efficacy) than aerobic exercises at Week 12&#xD;
           and 24? If yes, are these effects mediated by specific brain structural and functional&#xD;
           mechanisms?&#xD;
&#xD;
        3. Will aerobic exercises be more effective on improving physical health (motor functions,&#xD;
           physical fitness, and heart rate variability) than Tai Chi exercises at Week 12 and 24?&#xD;
           If yes, are these effects mediated by other specific brain structural and functional&#xD;
           mechanisms?&#xD;
&#xD;
        4. After 12 and 24 weeks of Tai Chi and aerobic exercises, what are the relationships&#xD;
           between reduction of cardiovascular risks and changes in brain structure and functions?&#xD;
&#xD;
      An assessor-blind randomized controlled clinical trial will be used. Based on known effect&#xD;
      size of Tai Chi exercises on cognitive function (please refer to CM03, pages 9-10), 120&#xD;
      sedentary middle-aged and older adults with cardiovascular risks will be recruited and&#xD;
      randomly assigned to the Tai Chi, Aerobic, or Control (usual care) group. The Tai Chi and&#xD;
      Aerobic groups will receive three one-hour exercise sessions weekly for 24 weeks, supervised&#xD;
      for the first 12 weeks and unsupervised for the next 12 weeks. The Control group will&#xD;
      maintain the original life style. Clinical measures of cardiovascular risks and blood&#xD;
      markers, brain structures and functional images, psychological (cognitive, psychological&#xD;
      well-being and exercise self-efficacy) and physical (motor functions, physical fitness, and&#xD;
      heart rate variability) functions will be collected at baseline, Week 12, and Week 24 to&#xD;
      compare differences among the three groups across the three time points. Investigators will&#xD;
      also examine the interrelationships of changes in brain structural and functional&#xD;
      organization with changes in other measures, in an effort to understand the neural mechanisms&#xD;
      of exercise effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Leukoaraiosis prevails in middle-aged and older adults with cardiovascular risks. People with&#xD;
      more severe leukoaraiosis would have greater risks for stroke, dementia, and disability. Tai&#xD;
      Chi and aerobic exercises both can reduce cardiovascular risks; however, it remains unknown&#xD;
      whether these two types of exercises also could prevent leukoaraiosis and associated declines&#xD;
      in physical and psychological functions. In particular, would Tai Chi, a form of mind-body&#xD;
      exercise, be more effective than aerobic exercises on improving psychological health with&#xD;
      specific underlying brain structural and functional mechanisms? Would aerobic exercise be&#xD;
      more effective than Tai Chi on improving physical healthy with different underlying brain&#xD;
      structural and functional mechanisms?&#xD;
&#xD;
      Therefore, in this three-year project, investigators will target on sedentary middle-aged and&#xD;
      older adults with cardiovascular risks, prescribe 24-week Tai Chi or aerobic exercises and&#xD;
      examine:&#xD;
&#xD;
        1. Whether both exercises are effective to reduce cardiovascular risks, prevent&#xD;
           leukoaraiosis and associated declines in physical and psychological functions at Week 12&#xD;
           and 24;&#xD;
&#xD;
        2. Will Tai Chi exercises be more effective on improving psychological health (cognition,&#xD;
           psychological well-being, and exercise self-efficacy) than aerobic exercises at Week 12&#xD;
           and 24? If yes, are these effects mediated by specific brain structural and functional&#xD;
           mechanisms?&#xD;
&#xD;
        3. Will aerobic exercises be more effective on improving physical health (motor functions,&#xD;
           physical fitness, and heart rate variability) than Tai Chi exercises at Week 12 and 24?&#xD;
           If yes, are these effects mediated by other specific brain structural and functional&#xD;
           mechanisms?&#xD;
&#xD;
        4. After 12 and 24 weeks of Tai Chi and aerobic exercises, what are the relationships&#xD;
           between reduction of cardiovascular risks and changes in brain structure and functions?&#xD;
&#xD;
      An assessor-blind randomized controlled clinical trial will be used. Based on known effect&#xD;
      size of Tai Chi exercises on cognitive function (please refer to CM03, pages 9-10), 120&#xD;
      sedentary middle-aged and older adults with cardiovascular risks will be recruited and&#xD;
      randomly assigned to the Tai Chi, Aerobic, or Control (usual care) group. The Tai Chi and&#xD;
      Aerobic groups will receive three one-hour exercise sessions weekly for 24 weeks, supervised&#xD;
      for the first 12 weeks and unsupervised for the next 12 weeks. The Control group will&#xD;
      maintain the original life style. Clinical measures of cardiovascular risks and blood&#xD;
      markers, brain structures and functional images, psychological (cognitive, psychological&#xD;
      well-being and exercise self-efficacy) and physical (motor functions, physical fitness, and&#xD;
      heart rate variability) functions will be collected at baseline, Week 12, and Week 24 to&#xD;
      compare differences among the three groups across the three time points. Investigators will&#xD;
      also investigate the interrelationships of changes in brain structural and functional&#xD;
      organization with changes in other measures, in an effort to understand the neural mechanisms&#xD;
      of exercise effects.&#xD;
&#xD;
      Results of this study will not only provide scientific evidence basis for clinical&#xD;
      decision-making of using exercise approaches to prevent the development of leukoaraiosis and&#xD;
      its negative health impact in middle-aged and older adults with cardiovascular risks, but&#xD;
      also reveal the underlying neural mechanisms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2020</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brain functional activation and structure imaging</measure>
    <time_frame>up to 6 months</time_frame>
    <description>fMRI activation patterns and white and gray matter changes of the brain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Scale for the Elderly</measure>
    <time_frame>up to 6 months</time_frame>
    <description>assess daily physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale short-form</measure>
    <time_frame>up to 6 months</time_frame>
    <description>assess emotional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness Attention Awareness Scale</measure>
    <time_frame>up to 6 months</time_frame>
    <description>assess mindfulness and attention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The AD8 scale</measure>
    <time_frame>baseline</time_frame>
    <description>A brief informant interview to detect dementia</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Maintain the original life style</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tai-Chi exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive three one-hour Tai Chi exercise sessions weekly for 24 weeks, supervised for the first 12 weeks and unsupervised for the next 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive three one-hour aerobic exercise sessions weekly for 24 weeks, supervised for the first 12 weeks and unsupervised for the next 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tai-Chi exercise</intervention_name>
    <description>Behavioral: Tai-Chi exercise</description>
    <arm_group_label>Tai-Chi exercise group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic exercise</intervention_name>
    <description>Behavioral: Aerobic exercise</description>
    <arm_group_label>Aerobic exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 45 and 80 years old&#xD;
&#xD;
          2. Literacy&#xD;
&#xD;
          3. With cardiovascular risks, defined as having hypertension (defined as resting systolic&#xD;
             BP≧140 mmHg or resting diastolic BP≧90 mmHg, or receiving antihypertensive&#xD;
             medication), diabetes mellitus (defined as taking oral antidiabetics or insulin or&#xD;
             fasting plasma glucose being ≥100 mg/dL), dyslipidemia (defined as receiving&#xD;
             lipid-lowering medication and diet therapy or total cholesterol &gt; 200 mg/dL or&#xD;
             triglyceride &gt; 150 mg/dL (Lan et al., 2008)), or a combination of two or three of&#xD;
             these risks&#xD;
&#xD;
          4. Being physically inactive (defined as being engaged in physical activities for less&#xD;
             than a total of 90 minutes per week) in recent one year&#xD;
&#xD;
          5. Have no prior experiences with Tai Chi, yoga, chi gung, or other meditative forms of&#xD;
             exercises&#xD;
&#xD;
          6. No expectation of the need of changing medication in the following 8 months from the&#xD;
             physicians&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Having any contraindications for fMRI (e.g., claustrophobia and indwelling metals or&#xD;
             implanted devices)&#xD;
&#xD;
          2. Serious or uncontrolled cardiac or metabolic conditions (e.g., unstable angina,&#xD;
             serious cardiac arrhythmias, heart failure, hypertrophic cardiomyopathy, severe aortic&#xD;
             or carotid stenosis, pulmonary embolus or infarction, resting systolic BP ≥ 180 mmHg,&#xD;
             resting diastolic BP ≥ 110 mmHg, fasting plasma glucose ≥ 300 mg/dL)&#xD;
&#xD;
          3. Severe renal failure&#xD;
&#xD;
          4. Symptoms or history of neurological diseases, including transient ischemic attack&#xD;
&#xD;
          5. Severe musculoskeletal disorders which would affect their mobility&#xD;
&#xD;
          6. Dementia or inability to follow instructions&#xD;
&#xD;
          7. Psychiatric disorder&#xD;
&#xD;
          8. Having contraindications for doing exercises (e.g., resting systolic BP ≥ 180 mmHg,&#xD;
             resting diastolic BP ≥ 110 mmHg, fasting plasma glucose ≥ 300 mg/dL, hypoglycemia&#xD;
             (plasma glucose ≤ 70 mg/dL) after exercises, and postural hypotension (BP drop ≥ 20&#xD;
             mmHg when changing postures)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pei-Fang Tang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pei-Fang Tang, PhD</last_name>
    <phone>02-33668128</phone>
    <email>pftang@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Collage of Public Health</name>
      <address>
        <city>Taipei</city>
        <state>Zhongzheng</state>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pei-Fang Tang, PhD</last_name>
      <phone>02-33668128</phone>
      <email>pftang@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neuroimage</keyword>
  <keyword>Training</keyword>
  <keyword>Aging</keyword>
  <keyword>Brain</keyword>
  <keyword>Cardiovascular risks</keyword>
  <pending_results>
    <submitted>February 20, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03275038
org study id: 201612213RINB
nct id: NCT03275038
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this three-year project, investigators will target on sedentary middle-aged and older
      adults with cardiovascular risks, prescribe 24-week Tai Chi or aerobic exercises and examine:

        1. Whether both exercises are effective to reduce cardiovascular risks, prevent
           leukoaraiosis and associated declines in physical and psychological functions at Week 12
           and 24;

        2. Will Tai Chi exercises be more effective on improving psychological health (cognition,
           psychological well-being, and exercise self-efficacy) than aerobic exercises at Week 12
           and 24? If yes, are these effects mediated by specific brain structural and functional
           mechanisms?

        3. Will aerobic exercises be more effective on improving physical health (motor functions,
           physical fitness, and heart rate variability) than Tai Chi exercises at Week 12 and 24?
           If yes, are these effects mediated by other specific brain structural and functional
           mechanisms?

        4. After 12 and 24 weeks of Tai Chi and aerobic exercises, what are the relationships
           between reduction of cardiovascular risks and changes in brain structure and functions?

      An assessor-blind randomized controlled clinical trial will be used. Based on known effect
      size of Tai Chi exercises on cognitive function (please refer to CM03, pages 9-10), 120
      sedentary middle-aged and older adults with cardiovascular risks will be recruited and
      randomly assigned to the Tai Chi, Aerobic, or Control (usual care) group. The Tai Chi and
      Aerobic groups will receive three one-hour exercise sessions weekly for 24 weeks, supervised
      for the first 12 weeks and unsupervised for the next 12 weeks. The Control group will
      maintain the original life style. Clinical measures of cardiovascular risks and blood
      markers, brain structures and functional images, psychological (cognitive, psychological
      well-being and exercise self-efficacy) and physical (motor functions, physical fitness, and
      heart rate variability) functions will be collected at baseline, Week 12, and Week 24 to
      compare differences among the three groups across the three time points. Investigators will
      also examine the interrelationships of changes in brain structural and functional
      organization with changes in other measures, in an effort to understand the neural mechanisms
      of exercise effects.
Leukoaraiosis prevails in middle-aged and older adults with cardiovascular risks. People with
      more severe leukoaraiosis would have greater risks for stroke, dementia, and disability. Tai
      Chi and aerobic exercises both can reduce cardiovascular risks; however, it remains unknown
      whether these two types of exercises also could prevent leukoaraiosis and associated declines
      in physical and psychological functions. In particular, would Tai Chi, a form of mind-body
      exercise, be more effective than aerobic exercises on improving psychological health with
      specific underlying brain structural and functional mechanisms? Would aerobic exercise be
      more effective than Tai Chi on improving physical healthy with different underlying brain
      structural and functional mechanisms?

      Therefore, in this three-year project, investigators will target on sedentary middle-aged and
      older adults with cardiovascular risks, prescribe 24-week Tai Chi or aerobic exercises and
      examine:

        1. Whether both exercises are effective to reduce cardiovascular risks, prevent
           leukoaraiosis and associated declines in physical and psychological functions at Week 12
           and 24;

        2. Will Tai Chi exercises be more effective on improving psychological health (cognition,
           psychological well-being, and exercise self-efficacy) than aerobic exercises at Week 12
           and 24? If yes, are these effects mediated by specific brain structural and functional
           mechanisms?

        3. Will aerobic exercises be more effective on improving physical health (motor functions,
           physical fitness, and heart rate variability) than Tai Chi exercises at Week 12 and 24?
           If yes, are these effects mediated by other specific brain structural and functional
           mechanisms?

        4. After 12 and 24 weeks of Tai Chi and aerobic exercises, what are the relationships
           between reduction of cardiovascular risks and changes in brain structure and functions?

      An assessor-blind randomized controlled clinical trial will be used. Based on known effect
      size of Tai Chi exercises on cognitive function (please refer to CM03, pages 9-10), 120
      sedentary middle-aged and older adults with cardiovascular risks will be recruited and
      randomly assigned to the Tai Chi, Aerobic, or Control (usual care) group. The Tai Chi and
      Aerobic groups will receive three one-hour exercise sessions weekly for 24 weeks, supervised
      for the first 12 weeks and unsupervised for the next 12 weeks. The Control group will
      maintain the original life style. Clinical measures of cardiovascular risks and blood
      markers, brain structures and functional images, psychological (cognitive, psychological
      well-being and exercise self-efficacy) and physical (motor functions, physical fitness, and
      heart rate variability) functions will be collected at baseline, Week 12, and Week 24 to
      compare differences among the three groups across the three time points. Investigators will
      also investigate the interrelationships of changes in brain structural and functional
      organization with changes in other measures, in an effort to understand the neural mechanisms
      of exercise effects.

      Results of this study will not only provide scientific evidence basis for clinical
      decision-making of using exercise approaches to prevent the development of leukoaraiosis and
      its negative health impact in middle-aged and older adults with cardiovascular risks, but
      also reveal the underlying neural mechanisms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Brain functional activation and structure imaging
time frame: up to 6 months
description: fMRI activation patterns and white and gray matter changes of the brain
measure: Physical Activity Scale for the Elderly
time frame: up to 6 months
description: assess daily physical activity
measure: Geriatric Depression Scale short-form
time frame: up to 6 months
description: assess emotional status
measure: Mindfulness Attention Awareness Scale
time frame: up to 6 months
description: assess mindfulness and attention
measure: The AD8 scale
time frame: baseline
description: A brief informant interview to detect dementia
arm group label: Control group
arm group type: No Intervention
description: Maintain the original life style
arm group label: Tai-Chi exercise group
arm group type: Experimental
description: Receive three one-hour Tai Chi exercise sessions weekly for 24 weeks, supervised for the first 12 weeks and unsupervised for the next 12 weeks
arm group label: Aerobic exercise group
arm group type: Experimental
description: Receive three one-hour aerobic exercise sessions weekly for 24 weeks, supervised for the first 12 weeks and unsupervised for the next 12 weeks
intervention type: Behavioral
intervention name: Tai-Chi exercise
description: Behavioral: Tai-Chi exercise
arm group label: Tai-Chi exercise group
intervention type: Behavioral
intervention name: Aerobic exercise
description: Behavioral: Aerobic exercise
arm group label: Aerobic exercise group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pei-Fang Tang, PhD
role: Principal Investigator
affiliation: National Taiwan University
last name: Pei-Fang Tang, PhD
phone: 02-33668128
email: pftang@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
submitted: February 20, 2023