Rhythm Experience and Africana Culture Trial

Cognitive Performance Clinical Trial

— REACT  

Official title:

Rhythm Experience and Africana Culture Trial II

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03771716
• Other study ID #: STUDY19020263
• Secondary ID: 1R01AG060741-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 21, 2019
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 151
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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).
• Fully vaccinated for COVID-19.

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).

Related Conditions & MeSH terms

• Brain Structure
• Cognitive Performance

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiorespiratory fitness	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.	Changes from baseline to 6-months
Other	Actigraphy steps per day	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.	Changes from baseline to 6-months
Other	Weight	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.	Changes from baseline to 6-months
Other	Loneliness	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.	Changes from baseline to 6-months
Other	Depression	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.	Changes from baseline to 6-months
Other	Functional magnetic resonance imaging (fMRI) task activation	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.	Changes from baseline to 6-months
Other	resting state functional connectivity	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.	Changes from baseline to 6-months
Other	Stroop Performance	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.	Changes from baseline to 6-months
Primary	Flanker Performance	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.	Changes from baseline to 6-months
Secondary	Hippocampal volume (mm3)	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.	Changes from baseline to 6-months