<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/NCT03771716</url>
  </required_header>
  <id_info>
    <org_study_id>R01AG060741</org_study_id>
    <secondary_id>1R01AG060741-01</secondary_id>
    <nct_id>NCT03771716</nct_id>
  </id_info>
  <brief_title>Rhythm Experience and Africana Culture Trial</brief_title>
  <acronym>REACT</acronym>
  <official_title>Rhythm Experience and Africana Culture Trial II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      REACT is a randomized intervention to examine the benefits of African Dance as a method to&#xD;
      increase physical activity behaviors in older adults. In this 6- month intervention, older&#xD;
      African Americans will be randomly assigned to either an African Dance or an Africana Culture&#xD;
      class. Both before and at the completion of the intervention, the investigators will collect&#xD;
      a comprehensive neuropsychological battery and MRI scans of brain health and function to&#xD;
      better study how physical activity influences neurocognitive health in African Americans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: Examine whether the African Dance intervention improves cognitive performance compared&#xD;
      to an educational control group. H1: The dance group will show cognitive improvements in a&#xD;
      domain-specific fashion such that executive and memory functions will be enhanced more than&#xD;
      other cognitive domains; Aim 2. Examine whether African Dance influences brain morphology,&#xD;
      task-evoked neural responses, cerebral blood flow, and resting state connectivity. H1: It is&#xD;
      predicted that African Dance will increase volume, white matter integrity, perfusion, and&#xD;
      functional activation/connectivity in a regionally-specific fashion such that prefrontal and&#xD;
      hippocampal areas will be more sensitive to the intervention than other brain regions. Aim 3.&#xD;
      Explore potential physiological and socio-emotional mechanisms of the dance intervention. The&#xD;
      investigators will collect measures of physical and psychosocial health such as waist&#xD;
      circumference, blood pressure, blood glucose and lipid levels, mood, anxiety, depression, and&#xD;
      loneliness and examine whether intervention-related changes to these measures mediate&#xD;
      improvements in cognitive performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 21, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 29, 2024</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>
    <intervention_model_description>180 African American older adults between the ages of 60-80 will be randomly assigned to one of two groups: African Dance or Africana Culture. Both groups will meet 3 times per week for 1 hour over a period of 6-months. Cognitive and brain metrics will be assessed at baseline and following the completion of the intervention.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Neither the investigator, nor outcomes assessors will know participants' group assignments. Participants will be instructed to refrain from speaking about their group's activities when visiting the lab for follow-up assessment. In addition, special care was taken to ensure that non-blinded laboratory staff (e.g., staff member notifying participants of their group assignments, staff monitoring the intervention classes) are not located in the same proximity in the laboratory, further preventing accidental unblinding.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stroop Performance</measure>
    <time_frame>Changes from baseline to 6-months</time_frame>
    <description>A Color-Word Stroop will be administered at baseline, and then following the intervention (6-months). The main outcome from this task is the Stroop effect (in ms). A higher Stroop effect indicates worse executive functioning. Group differences will be tested on this outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flanker Performance</measure>
    <time_frame>Changes from baseline to 6-months</time_frame>
    <description>A Flanker task will be administered at baseline, and then following the intervention (6-months). The main outcome from this task an interference effect (in ms) which indicates how much longer it takes for a participant to make a directional response to a center arrow when the flanking arrows are arranged in congruent vs. incongruent direction from the center stimulus. A higher interference effect indicates worse executive functioning. Group differences will be tested on this outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hippocampal volume (mm3)</measure>
    <time_frame>Changes from baseline to 6-months</time_frame>
    <description>Structural scans will be collected at baseline as well as following the intervention. Hippocampal volume will be calculated in mm3. The investigators will examine group differences in size of the hippocampus following the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory fitness</measure>
    <time_frame>Changes from baseline to 6-months</time_frame>
    <description>The investigators will conduct a sub-maximal fitness test before and after the intervention in order to calculate each participant's fitness level (via estimated V02 max). The investigators will examine group differences in fitness following the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actigraphy steps per day</measure>
    <time_frame>Changes from baseline to 6-months</time_frame>
    <description>The investigators will collect objective physical activity levels via wrist-worn accelerometers every 6 weeks throughout the intervention. Steps per day will be a primary outcome from the actigraphy. The investigators will examine changes in physical activity over the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Changes from baseline to 6-months</time_frame>
    <description>Participants will be weighed on a calibrated stadiometer both before and after the intervention. The investigators will examine percent changes in body weight in the groups before and after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loneliness</measure>
    <time_frame>Changes from baseline to 6-months</time_frame>
    <description>The investigators are collecting a questionnaire measuring self-perceived loneliness, the University of California Loneliness Scale (UCLALS). This is a 20-item scale in which participants rate frequency of feelings of loneliness and social isolation on a 4 point scale ranging from &quot;never&quot; to &quot;often&quot;. A total score is computed which can range from 20- 80. Higher scores indicate more loneliness. The questionnaire will be assessed at baseline as well as at the 6-month followup.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Changes from baseline to 6-months</time_frame>
    <description>The investigators are collecting a questionnaire measuring depressive symptoms, the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The questionnaire will be administered at baseline as well as at the 6-month followup.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional magnetic resonance imaging (fMRI) task activation</measure>
    <time_frame>Changes from baseline to 6-months</time_frame>
    <description>Participants will complete an N-back task while in the scanner. Task-evoked activation will be the primary outcome. The investigators will examine whether the pattern of task activation changes following the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>resting state functional connectivity</measure>
    <time_frame>Changes from baseline to 6-months</time_frame>
    <description>The investigators will examine changes in resting state functional connectivity using a region-of-interest-based approach centered on the hippocampus. The investigators will examine whether the strength of connectivity (z) of the hippocampus changes following the intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Cognitive Performance</condition>
  <condition>Brain Structure</condition>
  <arm_group>
    <arm_group_label>African Dance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the experimental group. Dance classes will be held 3 times per week for 1 hour. Participants will learn traditional Africana dance moves and sequences.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>African Cultural Immersion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This is the active control group. Participants will participate in a variety of educational activities related to African Culture, including traditional cooking, lectures, crafts, music and films. They will meet 3 times per week for the same duration as the Dance group. However, they will not participate in aerobic activity during the classes, and most activities will be conducted in a seated position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>African Dance</intervention_name>
    <description>Basic principles and guidelines for exercise programming will be followed including adequate warm-up and cool-down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity (PA) related injury. The African dance group will receive moderate intensity dance 1 hour per day, twice per week, for 6 months. The prescribed intensity will begin at light to moderate and progress to a moderate to high intensity level. Frequent assessment of heart rate and ratings of perceived exertion will ensure appropriate levels of intensity during each dance session. Levels of exertion during the dance will be prescribed and monitored based on baseline assessments of heart rate and cardiorespiratory fitness.</description>
    <arm_group_label>African Dance</arm_group_label>
    <other_name>Dance Group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>African Cultural Immersion</intervention_name>
    <description>The Culture group will participate in activities, including cooking, art and games, music, traditional crafts, and lectures and discussions about other aspects of Africana culture and customs. Topics will vary from session to session to maintain interest and engagement. The sessions will be held in a small group format and will be lead my personnel with training in each topic. Participants will meet 1 hour per day, 3 times per week, for 6 months.</description>
    <arm_group_label>African Cultural Immersion</arm_group_label>
    <other_name>Culture Group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  self identifies race as African American&#xD;
&#xD;
          -  between 60 and 80 years of age&#xD;
&#xD;
          -  ambulatory without pain or the assistance of walking devices&#xD;
&#xD;
          -  no history of falls or balance problems&#xD;
&#xD;
          -  able to speak and read English&#xD;
&#xD;
          -  available during the times classes are offered and able to make at least 80% of&#xD;
             classes (e.g., no long-term travel plans)&#xD;
&#xD;
          -  reliable means of transportation&#xD;
&#xD;
          -  scores above the range on the Brief Telephone Interview for Cognitive Status (TICS)&#xD;
             indicative of moderate to severe cognitive impairment (scores 21 or above)&#xD;
&#xD;
          -  no diagnosis of a neurological disease or psychiatric conditions&#xD;
&#xD;
          -  eligible to undergo MRI (not claustrophobic and no metal or history of injury&#xD;
             involving metal).&#xD;
&#xD;
          -  Fully vaccinated for COVID-19.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  self identifies race as other than African American&#xD;
&#xD;
          -  not between 60 and 80 years of age&#xD;
&#xD;
          -  not ambulatory without pain or the assistance of walking devices&#xD;
&#xD;
          -  history of falls or balance problems&#xD;
&#xD;
          -  unable to speak and read English&#xD;
&#xD;
          -  unavailable during the times classes are offered or unable to make at least 80% of&#xD;
             classes (e.g., indicates long-term travel plans during intervention period)&#xD;
&#xD;
          -  no reliable means of transportation&#xD;
&#xD;
          -  scores in range on the TICS indicative of moderate to severe cognitive impairment&#xD;
             (scores 21 or below)&#xD;
&#xD;
          -  has a diagnosis of a neurological disease or psychiatric condition&#xD;
&#xD;
          -  ineligible to undergo MRI (claustrophobic and/or metal in body or history of injury&#xD;
             involving metal).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kirk I Erickson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mihloti F Williams, MPH</last_name>
    <phone>4124072763</phone>
    <email>mihloti.williams@pitt.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kirk I Erickson, PhD</last_name>
    <phone>412-576-3724</phone>
    <email>kiericks@pitt.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mihloti Williams, MPH</last_name>
      <phone>412-407-2763</phone>
      <email>mihloti.williams@pitt.edu</email>
    </contact>
    <contact_backup>
      <last_name>Gabriella Nutter, B.A.</last_name>
      <phone>4124634588</phone>
      <email>gpn5@pitt.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Kirk Erickson, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 8, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Kirk Erickson, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT03771716
org study id: R01AG060741
secondary id: 1R01AG060741-01
nct id: NCT03771716
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
REACT is a randomized intervention to examine the benefits of African Dance as a method to
      increase physical activity behaviors in older adults. In this 6- month intervention, older
      African Americans will be randomly assigned to either an African Dance or an Africana Culture
      class. Both before and at the completion of the intervention, the investigators will collect
      a comprehensive neuropsychological battery and MRI scans of brain health and function to
      better study how physical activity influences neurocognitive health in African Americans.
Aim 1: Examine whether the African Dance intervention improves cognitive performance compared
      to an educational control group. H1: The dance group will show cognitive improvements in a
      domain-specific fashion such that executive and memory functions will be enhanced more than
      other cognitive domains; Aim 2. Examine whether African Dance influences brain morphology,
      task-evoked neural responses, cerebral blood flow, and resting state connectivity. H1: It is
      predicted that African Dance will increase volume, white matter integrity, perfusion, and
      functional activation/connectivity in a regionally-specific fashion such that prefrontal and
      hippocampal areas will be more sensitive to the intervention than other brain regions. Aim 3.
      Explore potential physiological and socio-emotional mechanisms of the dance intervention. The
      investigators will collect measures of physical and psychosocial health such as waist
      circumference, blood pressure, blood glucose and lipid levels, mood, anxiety, depression, and
      loneliness and examine whether intervention-related changes to these measures mediate
      improvements in cognitive performance.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 180 African American older adults between the ages of 60-80 will be randomly assigned to one of two groups: African Dance or Africana Culture. Both groups will meet 3 times per week for 1 hour over a period of 6-months. Cognitive and brain metrics will be assessed at baseline and following the completion of the intervention.
primary purpose: Basic Science
masking: Double (Investigator, Outcomes Assessor)
masking description: Neither the investigator, nor outcomes assessors will know participants' group assignments. Participants will be instructed to refrain from speaking about their group's activities when visiting the lab for follow-up assessment. In addition, special care was taken to ensure that non-blinded laboratory staff (e.g., staff member notifying participants of their group assignments, staff monitoring the intervention classes) are not located in the same proximity in the laboratory, further preventing accidental unblinding.
measure: Stroop Performance
time frame: Changes from baseline to 6-months
description: A Color-Word Stroop will be administered at baseline, and then following the intervention (6-months). The main outcome from this task is the Stroop effect (in ms). A higher Stroop effect indicates worse executive functioning. Group differences will be tested on this outcome.
measure: Flanker Performance
time frame: Changes from baseline to 6-months
description: A Flanker task will be administered at baseline, and then following the intervention (6-months). The main outcome from this task an interference effect (in ms) which indicates how much longer it takes for a participant to make a directional response to a center arrow when the flanking arrows are arranged in congruent vs. incongruent direction from the center stimulus. A higher interference effect indicates worse executive functioning. Group differences will be tested on this outcome.
measure: Hippocampal volume (mm3)
time frame: Changes from baseline to 6-months
description: Structural scans will be collected at baseline as well as following the intervention. Hippocampal volume will be calculated in mm3. The investigators will examine group differences in size of the hippocampus following the intervention.
measure: Cardiorespiratory fitness
time frame: Changes from baseline to 6-months
description: The investigators will conduct a sub-maximal fitness test before and after the intervention in order to calculate each participant's fitness level (via estimated V02 max). The investigators will examine group differences in fitness following the intervention.
measure: Actigraphy steps per day
time frame: Changes from baseline to 6-months
description: The investigators will collect objective physical activity levels via wrist-worn accelerometers every 6 weeks throughout the intervention. Steps per day will be a primary outcome from the actigraphy. The investigators will examine changes in physical activity over the intervention.
measure: Weight
time frame: Changes from baseline to 6-months
description: Participants will be weighed on a calibrated stadiometer both before and after the intervention. The investigators will examine percent changes in body weight in the groups before and after the intervention.
measure: Loneliness
time frame: Changes from baseline to 6-months
description: The investigators are collecting a questionnaire measuring self-perceived loneliness, the University of California Loneliness Scale (UCLALS). This is a 20-item scale in which participants rate frequency of feelings of loneliness and social isolation on a 4 point scale ranging from "never" to "often". A total score is computed which can range from 20- 80. Higher scores indicate more loneliness. The questionnaire will be assessed at baseline as well as at the 6-month followup.
measure: Depression
time frame: Changes from baseline to 6-months
description: The investigators are collecting a questionnaire measuring depressive symptoms, the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The questionnaire will be administered at baseline as well as at the 6-month followup.
measure: Functional magnetic resonance imaging (fMRI) task activation
time frame: Changes from baseline to 6-months
description: Participants will complete an N-back task while in the scanner. Task-evoked activation will be the primary outcome. The investigators will examine whether the pattern of task activation changes following the intervention.
measure: resting state functional connectivity
time frame: Changes from baseline to 6-months
description: The investigators will examine changes in resting state functional connectivity using a region-of-interest-based approach centered on the hippocampus. The investigators will examine whether the strength of connectivity (z) of the hippocampus changes following the intervention.
arm group label: African Dance
arm group type: Experimental
description: This is the experimental group. Dance classes will be held 3 times per week for 1 hour. Participants will learn traditional Africana dance moves and sequences.
arm group label: African Cultural Immersion
arm group type: Active Comparator
description: This is the active control group. Participants will participate in a variety of educational activities related to African Culture, including traditional cooking, lectures, crafts, music and films. They will meet 3 times per week for the same duration as the Dance group. However, they will not participate in aerobic activity during the classes, and most activities will be conducted in a seated position.
intervention type: Behavioral
intervention name: African Dance
description: Basic principles and guidelines for exercise programming will be followed including adequate warm-up and cool-down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity (PA) related injury. The African dance group will receive moderate intensity dance 1 hour per day, twice per week, for 6 months. The prescribed intensity will begin at light to moderate and progress to a moderate to high intensity level. Frequent assessment of heart rate and ratings of perceived exertion will ensure appropriate levels of intensity during each dance session. Levels of exertion during the dance will be prescribed and monitored based on baseline assessments of heart rate and cardiorespiratory fitness.
arm group label: African Dance
other name: Dance Group
intervention type: Behavioral
intervention name: African Cultural Immersion
description: The Culture group will participate in activities, including cooking, art and games, music, traditional crafts, and lectures and discussions about other aspects of Africana culture and customs. Topics will vary from session to session to maintain interest and engagement. The sessions will be held in a small group format and will be lead my personnel with training in each topic. Participants will meet 1 hour per day, 3 times per week, for 6 months.
arm group label: African Cultural Immersion
other name: Culture Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kirk I Erickson, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: Mihloti F Williams, MPH
phone: 4124072763
email: mihloti.williams@pitt.edu
last name: Kirk I Erickson, PhD
phone: 412-576-3724
email: kiericks@pitt.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Kirk Erickson, PhD
investigator title: Professor
sharing ipd: No