Clinical trial NCT03771716: Rhythm Experience and Africana Culture Trial
Official title: Rhythm Experience and Africana Culture Trial II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Brain Structure
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-12-11
Enrollment: 151
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Eligibility 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).
* 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).

Primary outcomes:
measure: Flanker Performance
timeFrame: Changes from baseline to 6-months
Secondary outcomes:
measure: Hippocampal volume (mm3)
timeFrame: Changes from baseline to 6-months
Other outcomes:
measure: Change in Cognitive Function
timeFrame: Changes from baseline to 6-months
measure: Medication Use
timeFrame: Changes from baseline to 6-months
measure: Cardiorespiratory fitness
timeFrame: Changes from baseline to 6-months
measure: Functional fitness
timeFrame: Changes from baseline to 6-months
measure: Actigraphy steps per day
timeFrame: Changes from baseline to 6-months
measure: Change in exercise frequency
timeFrame: Changes from baseline to 6-months
measure: Change in exercise intensity
timeFrame: Changes from baseline to 6-months
measure: Change in exercise duration
timeFrame: Changes from baseline to 6-months
measure: Weight
timeFrame: Changes from baseline to 6-months
measure: Change in hippocampal subfield volumes
timeFrame: Changes from baseline to 6-months
measure: Change in white matter lesions
timeFrame: Changes from baseline to 6-months
measure: Change in white matter diffusion properties
timeFrame: Changes from baseline to 6-months
measure: Change in cerebral blood flow
timeFrame: Changes from baseline to 6-months
measure: Change in resting state brain activity
timeFrame: Changes from baseline to 6-months
measure: Change in task-evoked relational memory brain activity
timeFrame: Changes from baseline to 6-months
measure: Change in task-evoked working memory brain activity
timeFrame: Changes from baseline to 6-months
measure: Change in cortical thickness
timeFrame: Changes from baseline to 6-months
measure: Changes in blood levels of cholesterol
timeFrame: Changes from baseline to 6-months
measure: Change in blood levels of glucose
timeFrame: Changes from baseline to 6-months
measure: Change in blood levels of hemoglobin
timeFrame: Changes from baseline to 6-months
measure: SES Composite
timeFrame: Baseline
measure: Health History & Lifestyle Habits
timeFrame: Changes from baseline to 6-months
measure: Depression
timeFrame: Changes from baseline to 6-months
measure: Loneliness
timeFrame: Changes from baseline to 6-months
measure: Mindfulness
timeFrame: Changes from baseline to 6-months
measure: Positive and Negative Affect
timeFrame: Changes from baseline to 6-months
measure: State Trait Anxiety Inventory
timeFrame: Changes from baseline to 6-months
measure: Perceived Pain
timeFrame: Changes from baseline to 6-months
measure: Perceived Fatigability
timeFrame: Changes from baseline to 6-months
measure: Levels of Inactivity
timeFrame: Changes from baseline to 6-months
measure: Lifestyle Physical Activities
timeFrame: Changes from baseline to 6-months
measure: Perceived Sleep Quality
timeFrame: Changes from baseline to 6-months
measure: Exercise Self-Efficacy
timeFrame: Changes from baseline to 6-months
measure: Barriers to Exercise
timeFrame: Changes from baseline to 6-months
measure: Social Provisions
timeFrame: Changes from baseline to 6-months
measure: Physical Activity Self-Regulation
timeFrame: Changes from baseline to 6-months
measure: Perceived Weight Discrimination
timeFrame: Changes from baseline to 6-months
measure: Perceived Health & Quality of Life
timeFrame: Changes from baseline to 6-months
measure: Life Satisfaction
timeFrame: Changes from baseline to 6-months
measure: Subjective Cognitive Performance
timeFrame: Changes from baseline to 6-months
measure: Perceived Cognitive Abilities
timeFrame: Changes from baseline to 6-months
measure: Perceived Cognition for Daily Life
timeFrame: Changes from baseline to 6-months
measure: Black Identity
timeFrame: 6-month post
measure: Race-Related Stress
timeFrame: 6-month post
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kirk I Erickson, PhD
role: PRINCIPAL_INVESTIGATOR
References: