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Rhythm Experience and Africana Culture Trial (REACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03771716
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kirk Erickson, PhD, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cognitive Performance Brain Structure Behavioral: African Dance Behavioral: African Cultural Immersion Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
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.
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.
Primary Purpose: Basic Science
Official Title: Rhythm Experience and Africana Culture Trial II
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : May 31, 2023

Arm Intervention/treatment
Experimental: African Dance
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.
Behavioral: African Dance
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.
Other Name: Dance Group

Active Comparator: African Cultural Immersion
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.
Behavioral: African Cultural Immersion
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.
Other Name: Culture Group




Primary Outcome Measures :
  1. Stroop Performance [ Time Frame: Changes from baseline to 6-months ]
    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.

  2. Flanker Performance [ Time Frame: Changes from baseline to 6-months ]
    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.

  3. Hippocampal volume (mm3) [ Time Frame: Changes from baseline to 6-months ]
    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.


Secondary Outcome Measures :
  1. Cardiorespiratory fitness [ Time Frame: Changes from baseline to 6-months ]
    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.

  2. Actigraphy steps per day [ Time Frame: Changes from baseline to 6-months ]
    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.

  3. Weight [ Time Frame: Changes from baseline to 6-months ]
    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.

  4. Loneliness [ Time Frame: Changes from baseline to 6-months ]
    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.

  5. Depression [ Time Frame: Changes from baseline to 6-months ]
    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.

  6. Functional magnetic resonance imaging (fMRI) task activation [ Time Frame: Changes from baseline to 6-months ]
    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.

  7. resting state functional connectivity [ Time Frame: Changes from baseline to 6-months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • self identifies race as African American
  • between 60 and 80 years of age
  • ambulatory without pain or the assistance of walking devices
  • no history of falls or balance problems
  • able to speak and read English
  • available during the times classes are offered and able to make at least 80% of classes (e.g., no long-term travel plans)
  • reliable means of transportation
  • scores above the range on the Brief Telephone Interview for Cognitive Status (TICS) indicative of moderate to severe cognitive impairment (scores 21 or above)
  • no diagnosis of a neurological disease or psychiatric conditions
  • eligible to undergo MRI (not claustrophobic and no metal or history of injury involving metal).

Exclusion Criteria:

  • self identifies race as other than African American
  • not between 60 and 80 years of age
  • not ambulatory without pain or the assistance of walking devices
  • history of falls or balance problems
  • unable to speak and read English
  • unavailable during the times classes are offered or unable to make at least 80% of classes (e.g., indicates long-term travel plans during intervention period)
  • no reliable means of transportation
  • scores in range on the TICS indicative of moderate to severe cognitive impairment (scores 21 or below)
  • has a diagnosis of a neurological disease or psychiatric condition
  • ineligible to undergo MRI (claustrophobic and/or metal in body or history of injury involving metal).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771716


Contacts
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Contact: Chelsea M Stillman, PhD 12077126847 cstillmancoyne@gmail.com
Contact: Kirk I Erickson, PhD 412-576-3724 kiericks@pitt.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Chelsea Stillman, Ph.D.    207-712-6847    cmstillm@gmail.com   
Contact: Mihloti Williams, B.A.       mihloti.williams@pitt.edu   
Principal Investigator: Kirk Erickson, PhD         
Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Kirk I Erickson, PhD University of Pittsburgh
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Responsible Party: Kirk Erickson, PhD, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03771716    
Other Study ID Numbers: R01AG060741 ( U.S. NIH Grant/Contract )
1R01AG060741-01 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No