<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/NCT04441645</url>
  </required_header>
  <id_info>
    <org_study_id>108MOST</org_study_id>
    <nct_id>NCT04441645</nct_id>
  </id_info>
  <brief_title>Acupressure on Cognitive Function and Quality of Life</brief_title>
  <official_title>Effects of Acupressure Intervention on Cognitive Function and Quality of Life in Older Adults With Cognitive Impairment in Long-term Care Settings: A Cluster-Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei 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 study aims to (1)compare differences of global cognitive function, working memory,&#xD;
      executive function, language function, and quality of life between institutionalized older&#xD;
      adults with MCI and with mild AD. Doing so, we can have a better understanding of the&#xD;
      cognitive performance and life quality at pre-dementia and dementia;(2)explore the effects of&#xD;
      the interventions with different acupoints(acupoints on head, acupoints on body, and&#xD;
      acupoints on head and body) on global cognitive function, working memory, executive function,&#xD;
      language function, and quality of life among institutionalized older adults with MCI and with&#xD;
      mild AD;(3) further investigate the long-term effects of the interventions on global&#xD;
      cognitive function, working memory, executive function, language function, and quality of&#xD;
      life among institutionalized older adults with MCI and with mild AD; doing this, we can&#xD;
      explore the pathological mechanism of the changes in the cognitive function through&#xD;
      neuropsychological assessments and the association between the changes in cognitive function&#xD;
      and in quality of life. We will recruit 32 residential care homes, with 256 older adults with&#xD;
      MCI and with mild AD for this single blind cluster randomized controlled trial with repeated&#xD;
      measures study. The facilities will be randomly assigned to the acupoint-on-head group,&#xD;
      acupoint-on-body group, acupoint-on-head-and-body group and control group, with a ratio of&#xD;
      1:1:1:1. Interventions are developed based on the theory of Chinese medicine. Except routine&#xD;
      care, the intervention groups will receive the acupressure once per day, five times per week,&#xD;
      a total of 12 weeks. Data will be collected at baseline, the 4th and 8th weeks during the&#xD;
      intervention, the end of the intervention, and the1st, 4th, and 8th months after the&#xD;
      intervention. The control group only will receive routine care and data collection is the&#xD;
      same as the intervention groups. Data assessors will not involve in the interventions and not&#xD;
      know the group allocation. The data analysis will use intent-to-treat analysis. The multiple&#xD;
      regression analysis, mixed effect model for repeated measure analysis, subgroup analysis, and&#xD;
      product-of-coefficient test will be performed to examine the effects of the interventions on&#xD;
      cognitive function and quality of life, and the associations among the changes in the&#xD;
      dependent variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although evidence has demonstrated that acupressure effectively improves older patients'&#xD;
      symptoms (e.g., sleep disturbance, behavior and psychological symptoms of dementia, etc.), it&#xD;
      is still lack of the study to investigate the effect of the acupressure on cognitive function&#xD;
      and quality of life among older adults with cognitive impairment in long-term care settings&#xD;
      and its long-term effects. In addition, according to statistical data for epidemiological&#xD;
      investigation, the majority is people with mild cognitive impairment (MCI) and mild dementia&#xD;
      (mild AD); hence, it is vital to prevent these two groups from having dementia or getting&#xD;
      worse. The study aims to (1)compare differences of global cognitive function, working memory,&#xD;
      executive function, language function, and quality of life between institutionalized older&#xD;
      adults with MCI and with mild AD. Doing so, we can have a better understanding of the&#xD;
      cognitive performance and life quality at pre-dementia and dementia;(2)explore the effects of&#xD;
      the interventions with different acupoints(acupoints on head, acupoints on body, and&#xD;
      acupoints on head and body) on global cognitive function, working memory, executive function,&#xD;
      language function, and quality of life among institutionalized older adults with MCI and with&#xD;
      mild AD;(3) further investigate the long-term effects of the interventions on global&#xD;
      cognitive function, working memory, executive function, language function, and quality of&#xD;
      life among institutionalized older adults with MCI and with mild AD; doing this, we can&#xD;
      explore the pathological mechanism of the changes in the cognitive function through&#xD;
      neuropsychological assessments and the association between the changes in cognitive function&#xD;
      and in quality of life. This single blind cluster randomized controlled trial with repeated&#xD;
      measures study will complete in 2 years. We will recruit 32 residential care homes in Taipei&#xD;
      City, with 256 older adults with MCI and with mild AD. The facilities will be randomly&#xD;
      assigned to the acupoint-on-head group, acupoint-on-body group, acupoint-on-head-and-body&#xD;
      group and control group, with a ratio of 1:1:1:1. Interventions are developed based on the&#xD;
      theory of Chinese medicine and the trained research assistants, also having traditional&#xD;
      Chinese nursing training, will perform the interventions. Except routine care, the&#xD;
      intervention groups will receive the acupressure once per day, five times per week, a total&#xD;
      of 12 weeks. Data will be collected at baseline, the 4th and 8th weeks during the&#xD;
      intervention, the end of the intervention, and the1st, 4th, and 8th months after the&#xD;
      intervention. The control group only will receive routine care and data collection is the&#xD;
      same as the intervention groups. Data assessors will not involve in the interventions and not&#xD;
      know the group allocation. The data analysis will use intent-to-treat analysis. The multiple&#xD;
      regression analysis, mixed effect model for repeated measure analysis, subgroup analysis, and&#xD;
      product-of-coefficient test will be performed to examine the effects of the interventions on&#xD;
      cognitive function and quality of life, and the associations among the changes in the&#xD;
      dependent variables. This study will promote the professional nursing autonomy and improve&#xD;
      life quality of the institutionalized older adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2021</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Cognitive Abilities Screening Instrument</measure>
    <time_frame>up to 12 months</time_frame>
    <description>a cognitive test screening for dementia in providing profiles of cognitive impairment by examining abilities on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment with score ranges of 0 to 100, respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Digit Span Test</measure>
    <time_frame>up to 12 months</time_frame>
    <description>a key tool for working verbal memory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Wisconsin Card Sorting Test</measure>
    <time_frame>up to 12 months</time_frame>
    <description>a neuropsychological test of the ability to display flexibility in the face of changing schedules of reinforcement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Semantic Association of Verbal Fluency</measure>
    <time_frame>up to 12 months</time_frame>
    <description>the generation of words from a given category within a pre-set time of 60 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life-Alzheimer's disease scale</measure>
    <time_frame>up to 12 months</time_frame>
    <description>The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">256</enrollment>
  <condition>Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>the acupoint-on-head group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pressing acupoints only on head</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the acupoint-on-body group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pressing acupoints only on body</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the acupoint-on-head-and-body group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pressing acupoints on head and body</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>routine care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupressure</intervention_name>
    <description>acupressure once per day, five times per week, a total of 12 weeks</description>
    <arm_group_label>the acupoint-on-body group</arm_group_label>
    <arm_group_label>the acupoint-on-head group</arm_group_label>
    <arm_group_label>the acupoint-on-head-and-body group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE):20~28&#xD;
&#xD;
          -  Clinical Dementia Rating (CDR): 0.5~1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CDR&gt;1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>I-Hui Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Medical University</name>
      <address>
        <city>Taipei</city>
        <zip>110</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University</investigator_affiliation>
    <investigator_full_name>I-Hui-Chen 陳逸卉</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- 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/NCT04441645
org study id: 108MOST
nct id: NCT04441645
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study aims to (1)compare differences of global cognitive function, working memory,
      executive function, language function, and quality of life between institutionalized older
      adults with MCI and with mild AD. Doing so, we can have a better understanding of the
      cognitive performance and life quality at pre-dementia and dementia;(2)explore the effects of
      the interventions with different acupoints(acupoints on head, acupoints on body, and
      acupoints on head and body) on global cognitive function, working memory, executive function,
      language function, and quality of life among institutionalized older adults with MCI and with
      mild AD;(3) further investigate the long-term effects of the interventions on global
      cognitive function, working memory, executive function, language function, and quality of
      life among institutionalized older adults with MCI and with mild AD; doing this, we can
      explore the pathological mechanism of the changes in the cognitive function through
      neuropsychological assessments and the association between the changes in cognitive function
      and in quality of life. We will recruit 32 residential care homes, with 256 older adults with
      MCI and with mild AD for this single blind cluster randomized controlled trial with repeated
      measures study. The facilities will be randomly assigned to the acupoint-on-head group,
      acupoint-on-body group, acupoint-on-head-and-body group and control group, with a ratio of
      1:1:1:1. Interventions are developed based on the theory of Chinese medicine. Except routine
      care, the intervention groups will receive the acupressure once per day, five times per week,
      a total of 12 weeks. Data will be collected at baseline, the 4th and 8th weeks during the
      intervention, the end of the intervention, and the1st, 4th, and 8th months after the
      intervention. The control group only will receive routine care and data collection is the
      same as the intervention groups. Data assessors will not involve in the interventions and not
      know the group allocation. The data analysis will use intent-to-treat analysis. The multiple
      regression analysis, mixed effect model for repeated measure analysis, subgroup analysis, and
      product-of-coefficient test will be performed to examine the effects of the interventions on
      cognitive function and quality of life, and the associations among the changes in the
      dependent variables.
Although evidence has demonstrated that acupressure effectively improves older patients'
      symptoms (e.g., sleep disturbance, behavior and psychological symptoms of dementia, etc.), it
      is still lack of the study to investigate the effect of the acupressure on cognitive function
      and quality of life among older adults with cognitive impairment in long-term care settings
      and its long-term effects. In addition, according to statistical data for epidemiological
      investigation, the majority is people with mild cognitive impairment (MCI) and mild dementia
      (mild AD); hence, it is vital to prevent these two groups from having dementia or getting
      worse. The study aims to (1)compare differences of global cognitive function, working memory,
      executive function, language function, and quality of life between institutionalized older
      adults with MCI and with mild AD. Doing so, we can have a better understanding of the
      cognitive performance and life quality at pre-dementia and dementia;(2)explore the effects of
      the interventions with different acupoints(acupoints on head, acupoints on body, and
      acupoints on head and body) on global cognitive function, working memory, executive function,
      language function, and quality of life among institutionalized older adults with MCI and with
      mild AD;(3) further investigate the long-term effects of the interventions on global
      cognitive function, working memory, executive function, language function, and quality of
      life among institutionalized older adults with MCI and with mild AD; doing this, we can
      explore the pathological mechanism of the changes in the cognitive function through
      neuropsychological assessments and the association between the changes in cognitive function
      and in quality of life. This single blind cluster randomized controlled trial with repeated
      measures study will complete in 2 years. We will recruit 32 residential care homes in Taipei
      City, with 256 older adults with MCI and with mild AD. The facilities will be randomly
      assigned to the acupoint-on-head group, acupoint-on-body group, acupoint-on-head-and-body
      group and control group, with a ratio of 1:1:1:1. Interventions are developed based on the
      theory of Chinese medicine and the trained research assistants, also having traditional
      Chinese nursing training, will perform the interventions. Except routine care, the
      intervention groups will receive the acupressure once per day, five times per week, a total
      of 12 weeks. Data will be collected at baseline, the 4th and 8th weeks during the
      intervention, the end of the intervention, and the1st, 4th, and 8th months after the
      intervention. The control group only will receive routine care and data collection is the
      same as the intervention groups. Data assessors will not involve in the interventions and not
      know the group allocation. The data analysis will use intent-to-treat analysis. The multiple
      regression analysis, mixed effect model for repeated measure analysis, subgroup analysis, and
      product-of-coefficient test will be performed to examine the effects of the interventions on
      cognitive function and quality of life, and the associations among the changes in the
      dependent variables. This study will promote the professional nursing autonomy and improve
      life quality of the institutionalized older adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The Cognitive Abilities Screening Instrument
time frame: up to 12 months
description: a cognitive test screening for dementia in providing profiles of cognitive impairment by examining abilities on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment with score ranges of 0 to 100, respectively.
measure: The Digit Span Test
time frame: up to 12 months
description: a key tool for working verbal memory.
measure: The Wisconsin Card Sorting Test
time frame: up to 12 months
description: a neuropsychological test of the ability to display flexibility in the face of changing schedules of reinforcement
measure: Semantic Association of Verbal Fluency
time frame: up to 12 months
description: the generation of words from a given category within a pre-set time of 60 seconds.
measure: Quality of life-Alzheimer's disease scale
time frame: up to 12 months
description: The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.
arm group label: the acupoint-on-head group
arm group type: Experimental
description: pressing acupoints only on head
arm group label: the acupoint-on-body group
arm group type: Experimental
description: pressing acupoints only on body
arm group label: the acupoint-on-head-and-body group
arm group type: Experimental
description: pressing acupoints on head and body
arm group label: the control group
arm group type: No Intervention
description: routine care
intervention type: Other
intervention name: Acupressure
description: acupressure once per day, five times per week, a total of 12 weeks
arm group label: the acupoint-on-body group
arm group label: the acupoint-on-head group
arm group label: the acupoint-on-head-and-body group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: I-Hui Chen
role: Principal Investigator
affiliation: Taipei Medical University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University
investigator full name: I-Hui-Chen 陳逸卉
investigator title: Associate Professor
mesh term: Cognitive Dysfunction