<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/NCT01696019</url>
  </required_header>
  <id_info>
    <org_study_id>Byrd-ARG2007</org_study_id>
    <nct_id>NCT01696019</nct_id>
  </id_info>
  <brief_title>Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders</brief_title>
  <acronym>SCIBHI</acronym>
  <official_title>A Pilot Randomized Intervention Study of Physical Exercise and Social Engagement in Chinese Elders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A pilot randomized clinical trial was conducted in a random sample of 120 non-demented&#xD;
      Chinese elders (ages 60-79) living in a defined community in Shanghai, China to compare the&#xD;
      effects of interventions (fast walking, Tai Chi, group intellectual discussion) to no&#xD;
      intervention with respect to change in cognition and whole brain volume determined by&#xD;
      repeated neuropsychological batteries and MRI scans. Aims included determining the&#xD;
      feasibility of recruiting and retaining a random sample of people age 60+ for such a trial as&#xD;
      well as collection of preliminary data on the efficacy of the interventions. The long-term&#xD;
      goal of this research program is to determine whether sustained physical and/or mental&#xD;
      exercise interventions are efficacious in delaying the onset of dementia and to understand&#xD;
      the role and mechanisms of brain growth in this process.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical exercise has been shown to increase brain volume and improve cognition in randomized&#xD;
      trials of non-demented elderly. Although greater social engagement was found to reduce&#xD;
      dementia risk in observational studies, randomized trials of social interventions have not&#xD;
      been reported. A representative sample of 120 elderly from Shanghai, China was randomized to&#xD;
      four groups (Tai Chi, Walking, Social Interaction, No Intervention) for 40 weeks. Two MRI's&#xD;
      were obtained, one before the intervention period, the other after. A neuropsychological&#xD;
      battery was administered at baseline, 20 weeks and 40 weeks. Comparison of changes in brain&#xD;
      volumes in intervention groups with the No Intervention group were assessed by t-tests.&#xD;
      Time-intervention group interactions for neuropsychological measures were evaluated with&#xD;
      repeated-measures mixed models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2008</start_date>
  <completion_date type="Actual">September 2009</completion_date>
  <primary_completion_date type="Actual">September 2009</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cognitive performance on battery of neuropsychological tests</measure>
    <time_frame>Baseline, 4 months, 8 months</time_frame>
    <description>A comprehensive battery of neuropsychological tests was administered by a psychometrist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in whole brain volume</measure>
    <time_frame>Baseline, 8 months</time_frame>
    <description>Structural MRIs were obtained at baseline and 8 months to provide data from which change in whole brain volume was determined.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Cognitive Impairment</condition>
  <condition>Dementia</condition>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Fast walking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route. Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises. Prior to the first session, each participant was given a pedometer with their name on it. They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement. At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded. A record of the number of steps taken for every participant at each session over the 40 week period was maintained.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tai Chi</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions. Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intellectual stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center. Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contact and testing only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The fourth group received no intervention. Contact was maintained by phone during the intervention period to reduce dropout. Participants were called four times during the 40 weeks intervention period by the study coordinator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fast walking</intervention_name>
    <description>Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route. Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises. Prior to the first session, each participant was given a pedometer with their name on it. They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement. At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded. A record of the number of steps taken for every participant at each session over the 40 week period was maintained.</description>
    <arm_group_label>Fast walking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tai Chi</intervention_name>
    <description>Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions. Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.</description>
    <arm_group_label>Tai Chi</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intellectual stimulation</intervention_name>
    <description>Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center. Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.</description>
    <arm_group_label>Intellectual stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Contact and testing only</intervention_name>
    <arm_group_label>Contact and testing only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  living in defined area&#xD;
&#xD;
          -  either sex&#xD;
&#xD;
          -  aged 60-79&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of stroke, Parkinson's disease or other neurologic disease&#xD;
&#xD;
          -  inability to walk unassisted for two kilometers or maintain balance with feet&#xD;
             side-by-side or semi-tandem for 10 seconds each&#xD;
&#xD;
          -  education-adjusted Chinese Mini-Mental Examination score &lt; 26 (to exclude individuals&#xD;
             with dementia or moderate cognitive impairment&#xD;
&#xD;
          -  cardiovascular or musculoskeletal conditions that would be contraindicated for the&#xD;
             intervention programs&#xD;
&#xD;
          -  contraindications for MRI&#xD;
&#xD;
          -  diagnosis of any illness that would preclude participation in the full study&#xD;
&#xD;
          -  regular vigorous exercise or Tai Chi practice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James A Mortimer, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Huashan Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Mortimer JA, Ding D, Borenstein AR, DeCarli C, Guo Q, Wu Y, Zhao Q, Chu S. Changes in brain volume and cognition in a randomized trial of exercise and social interaction in a community-based sample of non-demented Chinese elders. J Alzheimers Dis. 2012;30(4):757-66. doi: 10.3233/JAD-2012-120079.</citation>
    <PMID>22451320</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>September 27, 2012</last_update_submitted>
  <last_update_submitted_qc>September 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>magnetic resonance imaging</keyword>
  <keyword>cognition</keyword>
  <keyword>Tai Chi</keyword>
  <keyword>physical exercise</keyword>
  <keyword>mental exercise</keyword>
  <keyword>intervention trial</keyword>
  <keyword>prevention</keyword>
  <keyword>dementia</keyword>
  <keyword>Alzheimer disease</keyword>
  <keyword>mild cognitive impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <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/NCT01696019
org study id: Byrd-ARG2007
nct id: NCT01696019
lead sponsor: 
collaborator: 
has dmc: No
A pilot randomized clinical trial was conducted in a random sample of 120 non-demented
      Chinese elders (ages 60-79) living in a defined community in Shanghai, China to compare the
      effects of interventions (fast walking, Tai Chi, group intellectual discussion) to no
      intervention with respect to change in cognition and whole brain volume determined by
      repeated neuropsychological batteries and MRI scans. Aims included determining the
      feasibility of recruiting and retaining a random sample of people age 60+ for such a trial as
      well as collection of preliminary data on the efficacy of the interventions. The long-term
      goal of this research program is to determine whether sustained physical and/or mental
      exercise interventions are efficacious in delaying the onset of dementia and to understand
      the role and mechanisms of brain growth in this process.
Physical exercise has been shown to increase brain volume and improve cognition in randomized
      trials of non-demented elderly. Although greater social engagement was found to reduce
      dementia risk in observational studies, randomized trials of social interventions have not
      been reported. A representative sample of 120 elderly from Shanghai, China was randomized to
      four groups (Tai Chi, Walking, Social Interaction, No Intervention) for 40 weeks. Two MRI's
      were obtained, one before the intervention period, the other after. A neuropsychological
      battery was administered at baseline, 20 weeks and 40 weeks. Comparison of changes in brain
      volumes in intervention groups with the No Intervention group were assessed by t-tests.
      Time-intervention group interactions for neuropsychological measures were evaluated with
      repeated-measures mixed models.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in cognitive performance on battery of neuropsychological tests
time frame: Baseline, 4 months, 8 months
description: A comprehensive battery of neuropsychological tests was administered by a psychometrist.
measure: Change in whole brain volume
time frame: Baseline, 8 months
description: Structural MRIs were obtained at baseline and 8 months to provide data from which change in whole brain volume was determined.
arm group label: Fast walking
arm group type: Experimental
description: Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route. Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises. Prior to the first session, each participant was given a pedometer with their name on it. They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement. At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded. A record of the number of steps taken for every participant at each session over the 40 week period was maintained.
arm group label: Tai Chi
arm group type: Active Comparator
description: Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions. Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.
arm group label: Intellectual stimulation
arm group type: Active Comparator
description: Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center. Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.
arm group label: Contact and testing only
arm group type: Placebo Comparator
description: The fourth group received no intervention. Contact was maintained by phone during the intervention period to reduce dropout. Participants were called four times during the 40 weeks intervention period by the study coordinator.
intervention type: Other
intervention name: Fast walking
description: Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route. Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises. Prior to the first session, each participant was given a pedometer with their name on it. They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement. At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded. A record of the number of steps taken for every participant at each session over the 40 week period was maintained.
arm group label: Fast walking
intervention type: Other
intervention name: Tai Chi
description: Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions. Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.
arm group label: Tai Chi
intervention type: Other
intervention name: Intellectual stimulation
description: Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center. Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.
arm group label: Intellectual stimulation
intervention type: Other
intervention name: Contact and testing only
arm group label: Contact and testing only
criteria: 
gender: All
minimum age: 60 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James A Mortimer, Ph.D.
role: Principal Investigator
affiliation: University of South Florida
facility: 
country: China
citation: Mortimer JA, Ding D, Borenstein AR, DeCarli C, Guo Q, Wu Y, Zhao Q, Chu S. Changes in brain volume and cognition in a randomized trial of exercise and social interaction in a community-based sample of non-demented Chinese elders. J Alzheimers Dis. 2012;30(4):757-66. doi: 10.3233/JAD-2012-120079.
PMID: 22451320
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Cognitive Dysfunction