<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/NCT03252236</url>
  </required_header>
  <id_info>
    <org_study_id>HSEARS20131023003</org_study_id>
    <nct_id>NCT03252236</nct_id>
  </id_info>
  <brief_title>Tai Chi Training in Stroke Survivors</brief_title>
  <official_title>Effects of Mind-body Exercise on Cardiovascular Functions and Dual-tasking Performance in Chronic Stroke Survivors - a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic 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>
      People with stroke suffer from different impairments, including the ability to dual-tasking,&#xD;
      increased arterial stiffness, and dysfunction of the autonomic nervous system. The decrement&#xD;
      in dual-tasking performance has been found among stroke survivors, and the deterioration has&#xD;
      been related to increased risk of fall in the population. No coherent result has been&#xD;
      concluded from previous studies investigating the effect of different types of exercise&#xD;
      training on enhancing dual-tasking performance among healthy older adults and stroke&#xD;
      survivors.&#xD;
&#xD;
      Increased arterial stiffness and impaired functioning of the autonomic nervous systems, which&#xD;
      have been associated with increased cardiovascular risk and mortality, are common in stroke&#xD;
      survivors. Studies have been suggesting the beneficial effects of aerobic exercise on both&#xD;
      decreasing arterial stiffness and regulating the autonomic nervous system among healthy older&#xD;
      people. However, only a few studies concerning such topic have been conducted among stroke&#xD;
      survivors, yet the results were inconsistent.&#xD;
&#xD;
      Tai Chi is a Chinese traditional martial art and has been employed as a rehabilitation&#xD;
      exercise in recent decades. Tai Chi practitioners should perform the physical movement and&#xD;
      plan the Tai Chi forms simultaneously. The involvement of cognitive functioning gives Tai Chi&#xD;
      a dual-tasking character. Prior studies demonstrated the beneficial effect of Tai Chi&#xD;
      training on dual-tasking performance in healthy older adults, but would the effect extend to&#xD;
      stroke survivors has not yet been studied.&#xD;
&#xD;
      Also, Tai Chi is considered as a mind-body exercise. It is suggested that one should keep a&#xD;
      relaxed status of mind and breathe gently and slowly. Moreover, Tai Chi is an exercise with&#xD;
      moderate intensity. These features have been found to decrease arterial stiffness and benefit&#xD;
      functioning of the autonomic nervous system. Indeed, studies have been showing Tai Chi&#xD;
      reduces arterial stiffness and improves regulation of the autonomic nervous system among&#xD;
      healthy population. Whether such effect can be observed in stroke survivors is still unknown.&#xD;
&#xD;
      This study aimed at investigating the effects of Tai Chi training on dual-tasking&#xD;
      performance, arterial stiffness, and autonomic system functioning among stroke survivors.&#xD;
      Given the special features of Tai Chi and its advantageous effects on the mentioned&#xD;
      functioning, it is expected that stroke survivors may also benefit from Tai Chi training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies have been showing a deterioration of dual-tasking performance among stroke&#xD;
      survivors, especially when a dynamic physical task is involved. Dual-tasking performance has&#xD;
      been associated with risk of fall among stroke survivors. Results of prior studies on&#xD;
      investigating the effect of conventional exercise on dual-tasking performance in the&#xD;
      population have not been reaching a consistent conclusion.&#xD;
&#xD;
      Apart from the ability to dual-tasking, cardiovascular functioning, such as increased&#xD;
      arterial stiffness and dysfunction of the cardiac autonomic system, has also been found&#xD;
      compromised in stroke survivors. Such deterioration has been related to increased&#xD;
      cardiovascular risk and mortality. Research has been suggesting the beneficial effect of&#xD;
      aerobic exercise with moderate or high intensity on improving both the arterial stiffness and&#xD;
      autonomic functioning in healthy older adults.&#xD;
&#xD;
      Tai Chi is a Chinese traditional martial art and has been adopted as a rehabilitation&#xD;
      exercise in recent decades. Tai Chi can be considered as a dual-tasking exercise as its&#xD;
      practitioners should perform the physical movement, monitoring their action, and plan for the&#xD;
      next Tai Chi form simultaneously. Besides, Tai Chi is an exercise with moderate intensity. It&#xD;
      is also a mind-body exercise which emphasizes on maintaining a relaxed status of mind during&#xD;
      the practice. The mental status can be achieved by its meditation feature, as well as&#xD;
      synchronizing the Tai Chi movement with gentle, slow and deep breathing. The mind-body&#xD;
      characteristics of Tai Chi were similar to those factors proposed to improve the functioning&#xD;
      of the autonomic nervous system. Indeed, previous studies have been suggesting the beneficial&#xD;
      effects of Tai Chi training on dual-tasking performance, arterial compliance, and autonomic&#xD;
      regulation among healthy older adults. However, its effects on these functioning among stroke&#xD;
      survivors have not yet been established.&#xD;
&#xD;
      Given the characteristics of Tai Chi and previous studies on its therapeutic effects among&#xD;
      healthy older adults, the exercise may also benefit stroke survivors. This randomized&#xD;
      controlled trial, therefore, is designed to investigate the effect of Tai Chi training on&#xD;
      dual-tasking performance, arterial compliance, and functioning of the cardiac autonomic&#xD;
      nervous system among stroke survivors. The investigators expected that these functions would&#xD;
      be improved after Tai Chi training and the training effects would be better than those of the&#xD;
      conventional exercise in stroke survivors. If Tai Chi is found beneficial to dual-tasking,&#xD;
      vascular function, and autonomic regulation, the exercise may incorporate into the&#xD;
      rehabilitation program.&#xD;
&#xD;
      Eligible subjects (please refer to the 'Eligibility' part for inclusion and exclusion&#xD;
      criteria) were randomized into one of the three groups: Tai Chi, conventional exercise, or&#xD;
      control (please refer to the 'Arms and Interventions' part for details of each group). The&#xD;
      dual-tasking performance was assessed with three different physical tasks:&#xD;
      turning-while-walking, stepping back, and stepping down. These physical tasks were included&#xD;
      as they are common in daily life among community-dwelling stroke survivors but can also be&#xD;
      challenging to them. Moreover, these activities were among the most prevalent reasons for&#xD;
      fall among stroke survivors. Other assessment employed in this study can be found in the&#xD;
      'Outcome Measures' part. Assessment was conducted before, after, and one month after the&#xD;
      intervention period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>Change in dual-tasking performance - turning-while-walking</measure>
    <time_frame>week 0, week 12</time_frame>
    <description>A test combining a turning-while-walking test and an auditory Stroop test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in dual-tasking performance - stepping back</measure>
    <time_frame>week 0, week 12</time_frame>
    <description>A test combining a stepping back test and an auditory Stroop test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in dual-tasking performance - stepping down</measure>
    <time_frame>week 0, week 12</time_frame>
    <description>A test combining a stepping down test and an auditory Stroop test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in arterial compliance</measure>
    <time_frame>week 0, week 12</time_frame>
    <description>Large and small arterial compliance measured non-invasively (HDI/PulsewaveTM CR-2000 Research CardioVascular Profiling System; Hypertension Diagnostics, Inc., Eagan, Minnesota, USA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Single turning-while-walking test</measure>
    <time_frame>week 0, week 12, and week 16</time_frame>
    <description>A walking test in single-tasking condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single stepping back test</measure>
    <time_frame>week 0, week 12, and week 16</time_frame>
    <description>Stepping back under single-tasking condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single stepping down test</measure>
    <time_frame>week 0, week 12, and week 16</time_frame>
    <description>Stepping down under single-tasking condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single auditory Stroop test</measure>
    <time_frame>week 0, week 12, and week 16</time_frame>
    <description>A cognitive task under single-tasking condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>week 0, week 12, and week 16</time_frame>
    <description>Tested the functioning of the cardiac autonomic nervous system</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Tai Chi</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group were trained with Tai Chi exercise. The training lasted for 12 weeks, one hour per session and twice a week. Subjects were asked to practice outside of the class 30 minutes at least once a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group were trained with conventional exercises. Subjects were also asked to practice the exercises outside of the class 30 minutes at least once a week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No training was given to the subjects in this group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tai Chi</intervention_name>
    <description>Modified 12-form Yang style Tai Chi.</description>
    <arm_group_label>Tai Chi</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional exercise</intervention_name>
    <description>Conventional exercises included mobilization, stretching, muscle strengthening, and walking training.</description>
    <arm_group_label>Conventional exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with stroke six or more months previously&#xD;
&#xD;
          -  Able to perform a stepping down maneuver without any physical assistance&#xD;
&#xD;
          -  Able to walk unaided for 5m indoor&#xD;
&#xD;
          -  Able to follow instructions in Cantonese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any neurological disease other than stroke&#xD;
&#xD;
          -  Severe visual or hearing impairment&#xD;
&#xD;
          -  A score of less than 18 on the Cantonese version of the Mini-Mental Status Examination&#xD;
             (MMSE)&#xD;
&#xD;
          -  Any major surgery or severe musculoskeletal injury during the previous six months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Wai Nam Tsang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hong Kong Polytechnic University</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>William W. N. Tsang</investigator_full_name>
    <investigator_title>Associate Head</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Tai Chi</keyword>
  <keyword>Dual-tasking</keyword>
  <keyword>Arterial compliance</keyword>
  <keyword>Arterial stiffness</keyword>
  <keyword>Autonomic nervous system</keyword>
  <keyword>Heart rate variability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03252236
org study id: HSEARS20131023003
nct id: NCT03252236
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
People with stroke suffer from different impairments, including the ability to dual-tasking,
      increased arterial stiffness, and dysfunction of the autonomic nervous system. The decrement
      in dual-tasking performance has been found among stroke survivors, and the deterioration has
      been related to increased risk of fall in the population. No coherent result has been
      concluded from previous studies investigating the effect of different types of exercise
      training on enhancing dual-tasking performance among healthy older adults and stroke
      survivors.

      Increased arterial stiffness and impaired functioning of the autonomic nervous systems, which
      have been associated with increased cardiovascular risk and mortality, are common in stroke
      survivors. Studies have been suggesting the beneficial effects of aerobic exercise on both
      decreasing arterial stiffness and regulating the autonomic nervous system among healthy older
      people. However, only a few studies concerning such topic have been conducted among stroke
      survivors, yet the results were inconsistent.

      Tai Chi is a Chinese traditional martial art and has been employed as a rehabilitation
      exercise in recent decades. Tai Chi practitioners should perform the physical movement and
      plan the Tai Chi forms simultaneously. The involvement of cognitive functioning gives Tai Chi
      a dual-tasking character. Prior studies demonstrated the beneficial effect of Tai Chi
      training on dual-tasking performance in healthy older adults, but would the effect extend to
      stroke survivors has not yet been studied.

      Also, Tai Chi is considered as a mind-body exercise. It is suggested that one should keep a
      relaxed status of mind and breathe gently and slowly. Moreover, Tai Chi is an exercise with
      moderate intensity. These features have been found to decrease arterial stiffness and benefit
      functioning of the autonomic nervous system. Indeed, studies have been showing Tai Chi
      reduces arterial stiffness and improves regulation of the autonomic nervous system among
      healthy population. Whether such effect can be observed in stroke survivors is still unknown.

      This study aimed at investigating the effects of Tai Chi training on dual-tasking
      performance, arterial stiffness, and autonomic system functioning among stroke survivors.
      Given the special features of Tai Chi and its advantageous effects on the mentioned
      functioning, it is expected that stroke survivors may also benefit from Tai Chi training.
Previous studies have been showing a deterioration of dual-tasking performance among stroke
      survivors, especially when a dynamic physical task is involved. Dual-tasking performance has
      been associated with risk of fall among stroke survivors. Results of prior studies on
      investigating the effect of conventional exercise on dual-tasking performance in the
      population have not been reaching a consistent conclusion.

      Apart from the ability to dual-tasking, cardiovascular functioning, such as increased
      arterial stiffness and dysfunction of the cardiac autonomic system, has also been found
      compromised in stroke survivors. Such deterioration has been related to increased
      cardiovascular risk and mortality. Research has been suggesting the beneficial effect of
      aerobic exercise with moderate or high intensity on improving both the arterial stiffness and
      autonomic functioning in healthy older adults.

      Tai Chi is a Chinese traditional martial art and has been adopted as a rehabilitation
      exercise in recent decades. Tai Chi can be considered as a dual-tasking exercise as its
      practitioners should perform the physical movement, monitoring their action, and plan for the
      next Tai Chi form simultaneously. Besides, Tai Chi is an exercise with moderate intensity. It
      is also a mind-body exercise which emphasizes on maintaining a relaxed status of mind during
      the practice. The mental status can be achieved by its meditation feature, as well as
      synchronizing the Tai Chi movement with gentle, slow and deep breathing. The mind-body
      characteristics of Tai Chi were similar to those factors proposed to improve the functioning
      of the autonomic nervous system. Indeed, previous studies have been suggesting the beneficial
      effects of Tai Chi training on dual-tasking performance, arterial compliance, and autonomic
      regulation among healthy older adults. However, its effects on these functioning among stroke
      survivors have not yet been established.

      Given the characteristics of Tai Chi and previous studies on its therapeutic effects among
      healthy older adults, the exercise may also benefit stroke survivors. This randomized
      controlled trial, therefore, is designed to investigate the effect of Tai Chi training on
      dual-tasking performance, arterial compliance, and functioning of the cardiac autonomic
      nervous system among stroke survivors. The investigators expected that these functions would
      be improved after Tai Chi training and the training effects would be better than those of the
      conventional exercise in stroke survivors. If Tai Chi is found beneficial to dual-tasking,
      vascular function, and autonomic regulation, the exercise may incorporate into the
      rehabilitation program.

      Eligible subjects (please refer to the 'Eligibility' part for inclusion and exclusion
      criteria) were randomized into one of the three groups: Tai Chi, conventional exercise, or
      control (please refer to the 'Arms and Interventions' part for details of each group). The
      dual-tasking performance was assessed with three different physical tasks:
      turning-while-walking, stepping back, and stepping down. These physical tasks were included
      as they are common in daily life among community-dwelling stroke survivors but can also be
      challenging to them. Moreover, these activities were among the most prevalent reasons for
      fall among stroke survivors. Other assessment employed in this study can be found in the
      'Outcome Measures' part. Assessment was conducted before, after, and one month after the
      intervention period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in dual-tasking performance - turning-while-walking
time frame: week 0, week 12
description: A test combining a turning-while-walking test and an auditory Stroop test
measure: Change in dual-tasking performance - stepping back
time frame: week 0, week 12
description: A test combining a stepping back test and an auditory Stroop test
measure: Change in dual-tasking performance - stepping down
time frame: week 0, week 12
description: A test combining a stepping down test and an auditory Stroop test
measure: Change in arterial compliance
time frame: week 0, week 12
description: Large and small arterial compliance measured non-invasively (HDI/PulsewaveTM CR-2000 Research CardioVascular Profiling System; Hypertension Diagnostics, Inc., Eagan, Minnesota, USA)
measure: Single turning-while-walking test
time frame: week 0, week 12, and week 16
description: A walking test in single-tasking condition
measure: Single stepping back test
time frame: week 0, week 12, and week 16
description: Stepping back under single-tasking condition
measure: Single stepping down test
time frame: week 0, week 12, and week 16
description: Stepping down under single-tasking condition
measure: Single auditory Stroop test
time frame: week 0, week 12, and week 16
description: A cognitive task under single-tasking condition
measure: Heart rate variability
time frame: week 0, week 12, and week 16
description: Tested the functioning of the cardiac autonomic nervous system
arm group label: Tai Chi
arm group type: Experimental
description: Subjects in this group were trained with Tai Chi exercise. The training lasted for 12 weeks, one hour per session and twice a week. Subjects were asked to practice outside of the class 30 minutes at least once a week.
arm group label: Conventional exercise
arm group type: Active Comparator
description: Subjects in this group were trained with conventional exercises. Subjects were also asked to practice the exercises outside of the class 30 minutes at least once a week
arm group label: Control
arm group type: No Intervention
description: No training was given to the subjects in this group
intervention type: Behavioral
intervention name: Tai Chi
description: Modified 12-form Yang style Tai Chi.
arm group label: Tai Chi
intervention type: Behavioral
intervention name: Conventional exercise
description: Conventional exercises included mobilization, stretching, muscle strengthening, and walking training.
arm group label: Conventional exercise
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: William Wai Nam Tsang, PhD
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: William W. N. Tsang
investigator title: Associate Head
mesh term: Stroke
sharing ipd: Undecided