<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/NCT02978768</url>
  </required_header>
  <id_info>
    <org_study_id>99-3780B</org_study_id>
    <nct_id>NCT02978768</nct_id>
  </id_info>
  <brief_title>Tai Chi 6-Form Sports Apparatus With Alzheimer's Disease</brief_title>
  <official_title>The Effect of the Practice of Tai Chi 6-Form Sports Apparatus and Mental Training on Cognition, Self Care, Mood and General Health in Patients With Mild and Moderate Alzheimer's Disease: a Prospective Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the present project is to develop complementary and alternative medicine&#xD;
      (CAM) for The Chang Gung Dementia Center to alleviate the symptoms and signs of patients with&#xD;
      Alzheimer Disease, an approach aiming at decreasing the burden on family, society and nation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to statistics in Taiwan, two to four percent the elderly of aged more than 65 years&#xD;
      old have dementia. As the decreasing birth rate and the advancement of medical care making&#xD;
      life expectancy getting longer, the society in Taiwan is aging with a fast pace, leading to a&#xD;
      tremendous increase of patients suffering dementia. Many studies have shown that Tai Chi&#xD;
      Chuan can improve quality of life, cardiopulmonary function, pain control, mentality,&#xD;
      endurance, flexibility, balance, can decrease the possibility of incidental, and enhance&#xD;
      immunity and sleep quality in the elderly. Many studies showed that higher physical activity&#xD;
      or mental training is associated with reduced risk for Alzheimer Disease. However, Tai Chi&#xD;
      Chuan could be a little difficult for elderly people with dementia because they can't&#xD;
      remember so that the investigators have designed Tai Chi 6-Form sports apparatus and the&#xD;
      clinical trial was done for health and stroke elderly people. Also, the investigators have&#xD;
      developed a mental training program for patients with Alzheimer Disease. The objective of the&#xD;
      present project is to develop complementary and alternative medicine (CAM) for The Chang Gung&#xD;
      Dementia Center to alleviate the symptoms and signs of patients with Alzheimer Disease, an&#xD;
      approach aiming at decreasing the burden on family, society and nation.&#xD;
&#xD;
        1. Study aims during the first year: the investigators investigate the effect of Tai Chi&#xD;
           6-Form accompanied with music rhythm for patients with dementia to remember in&#xD;
           behavioral and general health, functional and cognitive decline as well as family&#xD;
           caregiver's satisfaction, the use of health care services, and recommendation for other&#xD;
           people among patients with mild and moderate Alzheimer Disease.&#xD;
&#xD;
        2. Study aims during the second year: the investigators investigate the effect of mental&#xD;
           training with computer mind training games on behavioral and general health, functional&#xD;
           and cognitive decline as well as the use of health care services and family caregiver's&#xD;
           satisfaction and recom mendation for other people among patients with mild and moderate&#xD;
           Alzheimer Disease.&#xD;
&#xD;
        3. Study aims during the third year: the investigators investigate the effect of tele-Tai&#xD;
           Chi 6-Form and mental training on line which are to combine to physico-mental&#xD;
           rehabilitation Wii (PM Wii) on behavioral and general health, functional and cognitive&#xD;
           decline as well as the use of health care services and family caregiver's satisfaction&#xD;
           and recommendation for other people among patients with mild and moderate Alzheimer&#xD;
           Disease. According to Tai Chi 6-Form, the investigators will develop the software to&#xD;
           watch Tai Chi 6-Form exercise on computer on line. The patient can copy Tai Chi 6-Form&#xD;
           movement accompanied with previous music rhythm at home. Therefore, Tai Chi 6-Form and&#xD;
           mental training which are a great benefit to patients with dementia will be popular at&#xD;
           home or in the community. Patients with dementia return back to the community.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Factorial Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>Up to 3 year</time_frame>
    <description>Outcome measures showed that mild and moderate AD participants received 12-week Tai Chi 6-Form exercise training can improved at balance score, and 12-week computer-based cognitive training may be able to improve their ability to understand instructions and reflected in task execution. In this study, 12-week PM Wii shows no significant difference at balance performance or cognitive function, probably due to the insufficient training intensity and lack of sensory feedback. However, tele-care system is the development trends in the future undoubtedly.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First year, the investigators investigate the effect of 12-week Tai Chi 6-Form accompanied with music rhythm for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Second year, the investigators investigate the effect of 12-week computer-based cognitive training games for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physico-Mental training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Third year, the investigators investigate the effect of 12-week Physico-Mental rehabilitation Wii (PM Wii) for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>First year, the investigators investigate the effect of 12-week Tai Chi 6-Form accompanied with music rhythm for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computer-based cognitive training</intervention_name>
    <description>Second year, the investigators investigate the effect of 12-week computer-based cognitive training games for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.</description>
    <arm_group_label>Cognitive training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Physico-Mental rehabilitation Wii</intervention_name>
    <description>Third year, the investigators investigate the effect of 12-week Physico-Mental rehabilitation Wii (PM Wii) for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.</description>
    <arm_group_label>Physico-Mental training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild and Moderate Alzheimer's Disease(AD) participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pacemaker patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>59 Years</minimum_age>
    <maximum_age>92 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alice M Wong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>TaoYuan county</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Alice May-Kuen Wong</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <keyword>dementia</keyword>
  <keyword>Tai Chi</keyword>
  <keyword>mental training</keyword>
  <keyword>cognitive rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02978768
org study id: 99-3780B
nct id: NCT02978768
lead sponsor: 
has dmc: Yes
The objective of the present project is to develop complementary and alternative medicine
      (CAM) for The Chang Gung Dementia Center to alleviate the symptoms and signs of patients with
      Alzheimer Disease, an approach aiming at decreasing the burden on family, society and nation.
According to statistics in Taiwan, two to four percent the elderly of aged more than 65 years
      old have dementia. As the decreasing birth rate and the advancement of medical care making
      life expectancy getting longer, the society in Taiwan is aging with a fast pace, leading to a
      tremendous increase of patients suffering dementia. Many studies have shown that Tai Chi
      Chuan can improve quality of life, cardiopulmonary function, pain control, mentality,
      endurance, flexibility, balance, can decrease the possibility of incidental, and enhance
      immunity and sleep quality in the elderly. Many studies showed that higher physical activity
      or mental training is associated with reduced risk for Alzheimer Disease. However, Tai Chi
      Chuan could be a little difficult for elderly people with dementia because they can't
      remember so that the investigators have designed Tai Chi 6-Form sports apparatus and the
      clinical trial was done for health and stroke elderly people. Also, the investigators have
      developed a mental training program for patients with Alzheimer Disease. The objective of the
      present project is to develop complementary and alternative medicine (CAM) for The Chang Gung
      Dementia Center to alleviate the symptoms and signs of patients with Alzheimer Disease, an
      approach aiming at decreasing the burden on family, society and nation.

        1. Study aims during the first year: the investigators investigate the effect of Tai Chi
           6-Form accompanied with music rhythm for patients with dementia to remember in
           behavioral and general health, functional and cognitive decline as well as family
           caregiver's satisfaction, the use of health care services, and recommendation for other
           people among patients with mild and moderate Alzheimer Disease.

        2. Study aims during the second year: the investigators investigate the effect of mental
           training with computer mind training games on behavioral and general health, functional
           and cognitive decline as well as the use of health care services and family caregiver's
           satisfaction and recom mendation for other people among patients with mild and moderate
           Alzheimer Disease.

        3. Study aims during the third year: the investigators investigate the effect of tele-Tai
           Chi 6-Form and mental training on line which are to combine to physico-mental
           rehabilitation Wii (PM Wii) on behavioral and general health, functional and cognitive
           decline as well as the use of health care services and family caregiver's satisfaction
           and recommendation for other people among patients with mild and moderate Alzheimer
           Disease. According to Tai Chi 6-Form, the investigators will develop the software to
           watch Tai Chi 6-Form exercise on computer on line. The patient can copy Tai Chi 6-Form
           movement accompanied with previous music rhythm at home. Therefore, Tai Chi 6-Form and
           mental training which are a great benefit to patients with dementia will be popular at
           home or in the community. Patients with dementia return back to the community.
allocation: Non-Randomized
intervention model: Factorial Assignment
masking: None (Open Label)
measure: Balance
time frame: Up to 3 year
description: Outcome measures showed that mild and moderate AD participants received 12-week Tai Chi 6-Form exercise training can improved at balance score, and 12-week computer-based cognitive training may be able to improve their ability to understand instructions and reflected in task execution. In this study, 12-week PM Wii shows no significant difference at balance performance or cognitive function, probably due to the insufficient training intensity and lack of sensory feedback. However, tele-care system is the development trends in the future undoubtedly.
arm group label: Exercise
arm group type: Experimental
description: First year, the investigators investigate the effect of 12-week Tai Chi 6-Form accompanied with music rhythm for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.
arm group label: Cognitive training
arm group type: Experimental
description: Second year, the investigators investigate the effect of 12-week computer-based cognitive training games for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.
arm group label: Physico-Mental training
arm group type: Experimental
description: Third year, the investigators investigate the effect of 12-week Physico-Mental rehabilitation Wii (PM Wii) for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.
intervention type: Other
intervention name: Exercise
description: First year, the investigators investigate the effect of 12-week Tai Chi 6-Form accompanied with music rhythm for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.
arm group label: Exercise
intervention type: Device
intervention name: Computer-based cognitive training
description: Second year, the investigators investigate the effect of 12-week computer-based cognitive training games for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.
arm group label: Cognitive training
intervention type: Device
intervention name: Physico-Mental rehabilitation Wii
description: Third year, the investigators investigate the effect of 12-week Physico-Mental rehabilitation Wii (PM Wii) for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.
arm group label: Physico-Mental training
criteria: 
gender: All
minimum age: 59 Years
maximum age: 92 Years
healthy volunteers: No
last name: Alice M Wong, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Alice May-Kuen Wong
investigator title: Attending Physician
mesh term: Alzheimer Disease
sharing ipd: No