Rhythm Experience and Africana Culture Trial (REACT)
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|ClinicalTrials.gov Identifier: NCT03771716|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : June 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Performance Brain Structure||Behavioral: African Dance Behavioral: African Cultural Immersion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Chelsea M Stillman, PhDemail@example.com|
|Contact: Kirk I Erickson, PhDfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15260|
|Contact: Chelsea Stillman, Ph.D. 207-712-6847 email@example.com|
|Contact: Mihloti Williams, B.A. firstname.lastname@example.org|
|Principal Investigator: Kirk Erickson, PhD|
|Principal Investigator:||Kirk I Erickson, PhD||University of Pittsburgh|