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: May 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	Change in Cognitive Function	Investigators are assessing change in cognitive function from baseline to 12 months. A comprehensive neuropsychological battery will be used that assesses 5 domains of cognitive function (Working Memory, Processing Speed, Episodic Memory, Attentional Control, and Visuospatial Function). We will perform a confirmatory factor analysis on the cognitive data and determine whether the exercise intervention influences performance as measured by these factors. There is no min and max values. These are generated from a confirmatory factor analysis that normalizes the scores around 0 (being the mean). As such, positive values reflect better performance and negative values reflect poorer cognitive performance. Since the scores are standardized we can calculate the changes in standard deviations - e.g., a shift of 0.5 would be an improvement of ½ standard deviation in performance based on the sample average.	Changes from baseline to 6-months
Other	Medication Use	We will be recording all prescribed and OTC medications that the study participant is currently taking and will examine whether the intervention effects vary as a function of medication use.	Changes from baseline to 6-months
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 VO2 max). The investigators will examine group differences in fitness following the intervention.	Changes from baseline to 6-months
Other	Functional fitness	Senior Fitness Test will be used to measure various aspects of fitness - e.g., balance, flexibility, strength. We will examine whether the exercise intervention improves any marker of fitness.	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	Change in exercise frequency	Exercise frequency will be measured using Actigraph Link physical activity monitoring device. This device is small and lightweight. It is worn around the non-dominant wrist(touching the skin) for approximately 7 days during all waking and sleeping hours. We will examine whether the intervention altered this measure of daily activity.	Changes from baseline to 6-months
Other	Change in exercise intensity	Exercise intensity will be measured using the Actigraph Link physical activity monitoring device. This device is small and lightweight. It is worn around the non-dominant wrist (touching the skin) for approximately 7 days during all waking and sleeping hours. We will examine whether the exercise intervention altered amount of time spent in moderate-to-vigorous activities during daily life.	Changes from baseline to 6-months
Other	Change in exercise duration	Exercise duration will be measured using Actigraph Link physical activity monitoring device. This device is small and lightweight. It is worn around the non-dominant wrist (touching the skin) for approximately 7 days during all waking and sleeping hours.. The duration is measured in minutes. We will examine whether the exercise intervention altered amount of time spent in moderate-to-vigorous activities during daily life.	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	Change in hippocampal subfield volumes	MRI will be used to measure volumetric changes in hippocampal subfields.	Changes from baseline to 6-months
Other	Change in white matter lesions	MRI will be used to measure changes in white matter microstructure in relation to the intervention.	Changes from baseline to 6-months
Other	Change in white matter diffusion properties	MRI will be used to measure changes in white matter microstructure in relation to the intervention.	Changes from baseline to 6-months
Other	Change in cerebral blood flow	MRI will be used to measure changes in cerebral blood flow. Total cerebral blood flow changes over the course of the intervention will be evaluated.	Changes from baseline to 6-months
Other	Change in resting state brain activity	MRI will be used to measure changes in resting state brain function. We will examine whether the intervention alters resting state connectivity metrics.	Changes from baseline to 6-months
Other	Change in task-evoked relational memory brain activity	MRI will be used to measure changes in encoding and retrieval during a relational memory task.	Changes from baseline to 6-months
Other	Change in task-evoked working memory brain activity	MRI will be used to measure changes in brain activity task-evoked patterns using an N-back working memory task.	Changes from baseline to 6-months
Other	Change in cortical thickness	MRI will be used to measure average cortical thickness over the course of the intervention.	Changes from baseline to 6-months
Other	Changes in blood levels of cholesterol	The investigators are collecting data on changes in blood biomarkers including levels of cholesterol, LDL, VLDL, HDL, and triglycerides.	Changes from baseline to 6-months
Other	Change in blood levels of glucose	The investigators will examine whether changes in markers of insulin resistance change over the course of the intervention and whether these changes mediate neurocognitive outcomes.	Changes from baseline to 6-months
Other	Change in blood levels of hemoglobin	The investigators are collecting data on changes in average blood sugar levels using an A1C test	Changes from baseline to 6-months
Other	SES Composite	Combining information from the MacArthur questionnaire to develop Social Economic Status of participants, we will examine whether the effectiveness of the intervention varied by SES levels of the participants. The SES composite is generated using a confirmatory factor analysis of various SES indicators - e.g., income, debt, savings, etc. The scores are normalized so that 0 is the average for the sample, higher numbers reflect higher SES, and lower numbers indicate lower SES.	Baseline
Other	Health History & Lifestyle Habits	Health History assesses medical history and lifestyle habits such as alcohol and tobacco use. We will examine whether any neurocognitive outcomes vary as a function of these health conditions and behaviors.	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	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	Mindfulness	The MAAS assesses a core characteristic of mindfulness mainly open or receptive awareness of and attention to what is taking place in the present. We will examine whether the exercise intervention altered measures of mindfulness. Score scale runs 15-90 with higher scores reflecting more mindfulness.	Changes from baseline to 6-months
Other	Positive and Negative Affect	The Positive and Negative Affect Schedule (PANAS) is used to measure mood and emotion. It is comprised of 20 items, with 10 items measuring positive affect (e.g., excited, inspired) and 10 items measuring negative affect (e.g., upset, afraid). Each item is rated on a five-point Likert scale. Positive affect scores range from 10 to 50, and negative affect scores range from 10 to 50.	Changes from baseline to 6-months
Other	State Trait Anxiety Inventory	The STAI is a validated 20 item self-report assessment which includes separate measures of state and trait anxiety. The inventory includes 40 items on a 4-point Likert scale. Higher scores indicate higher levels of anxiety.	Changes from baseline to 6-months
Other	Perceived Pain	The McGill Pain Questionnaire is used to evaluate a person's perception of pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention. We will examine whether the intervention alters perceptions of pain in late adulthood. Score scale runs 0-45 with higher values meaning more pain.	Changes from baseline to 6-months
Other	Perceived Fatigability	The Pittsburgh Fatigability Scale assesses self-report whole-body physical and mental tiredness related to activities of fixed intensity and duration in adults age =60. The scale includes 10 items, each measured on a 5-point Likert scale for a total score of 0-50. Higher scores indicate higher fatigability.	Changes from baseline to 6-months
Other	Levels of Inactivity	Sitting Time Questionnaire scores how much time is spent sitting during 5 different events on a weekday and weekend day. We will examine whether participating in the intervention alters amount of time spent sitting. Calculate weekly minutes with higher values in minutes = more sedentary (sitting time)	Changes from baseline to 6-months
Other	Lifestyle Physical Activities	The Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire assesses self-report weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults. It includes activities of various intensities (from light to vigorous) such as walking, running, hiking, swimming, bicycling, dancing, tennis, aerobics, yoga/tai chi, gardening, and housework. For each activity, the following measures are scored: frequency per week, hours per week, estimated caloric expenditure per week, and mets/kg/week.	Changes from baseline to 6-months
Other	Perceived Sleep Quality	Pittsburgh Sleep Quality Index (PSQI) will be used to assess perceived sleep quality. We will examine whether the exercise intervention alters perceived sleep quality. All components have score range 0-3 with lower number equal to better sleep quality.	Changes from baseline to 6-months
Other	Exercise Self-Efficacy	The investigators will use the Exercise Self-Efficacy Scale (EXSE) to assess belief in the ability to continue exercising three times a week at a moderate intensity for 40 plus minutes a session into the future. We will examine whether this measure predicts long-term adherence outcomes. Score scale runs 0-100 with higher values = higher confidence to continue to exercise (3X's week for 40 + minutes) in the future 8 weeks	Changes from baseline to 6-months
Other	Barriers to Exercise	BARSE questionnaire assess degrees of confidence that one could exercise despite a variety of limitations such as during bad weather, while on vacation, etc. This scale was designed to tap subjects' perceived capabilities to exercise three times per week for 40 minutes over the next two months in the face of commonly identified barriers to participation. We will examine whether measures of barriers predicts adherence and compliance to the intervention. Scale 1-100, higher values = higher level of perceived capability to overcome barriers to exercise	Changes from baseline to 6-months
Other	Social Provisions	Social Provisions Scale (SPS):A 24-item scale assessing six relational provisions: attachment, or emotional support; social integration, or network support; reassurance of worth, or esteem support; reliable alliance, or tangible aid; guidance, or informational support; and the opportunity of nurturance.The items were modified for the exercise setting. For example, one of the statements used to assess social integration was "I feel part of the exercise group". We will examine whether social provisions relates to adherence to the intervention. Each subscale has range of 4 - 16 with total score range 24 - 96, higher values = higher social relationship (ppt. is receiving that provision)	Changes from baseline to 6-months
Other	Physical Activity Self-Regulation	Physical Activity Self-Regulation Scale, 12-item version (PASR-12): (PASR-12 FORM) A 12-item version of a popular 43-item self-regulation scale. Participants were asked to rate how often they used each strategy on a scale from 1 (never) to 5 (very often). We will examine whether measures of self-regulation predicts adherence and compliance to the intervention. Each subscale has range of 2 - 10, higher scores = greater use of self-regulation strategies. Summary score has range of 12 - 60	Changes from baseline to 6-months
Other	Perceived Weight Discrimination	Hunger and Major (2015) developed a perceived weight discrimination scale based on a widely-used measure of racial discrimination. Participants respond to five items (e.g., "In the past 12 months, how often other people treated you unfairly because of your weight?") on 0 (never) to 4 (all the time) scales. We will examine whether the exercise intervention modified measures of perceived weight discrimination.	Changes from baseline to 6-months
Other	Perceived Health & Quality of Life	The SF-36 taps into eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. We will examine whether the exercise intervention modified measures of health related quality of life. Each concept has a score range of 0-100 with higher scores equal to more favorable health traits.	Changes from baseline to 6-months
Other	Life Satisfaction	We will use the Satisfaction with Life Scale (SWLS) as a global cognitive judgement of study participants life satisfaction. We will examine whether the exercise intervention altered SWLS measures. Total score range is 5 -35 with higher scores equal to greater satisfaction with life.	Changes from baseline to 6-months
Other	Subjective Cognitive Performance	Everyday Cognition (ECOG)(Short version) measures subjective cognitive performance. We will examine whether the intervention alters this subjective/perceived level of cognitive function. Score range is 1 - 4 with lower scores equal to better daily function.	Changes from baseline to 6-months
Other	Perceived Cognitive Abilities	PROMIS Applied Cognition: (Abilities) This is a brief self-report of perceived cognitive abilities for daily functioning. We will examine whether the intervention alters this subjective/perceived level of cognitive function. Scale 8-40, assess ppt. perceived functional abilities in regard to cognitive tasks. Higher value = higher self-perceived ability in cognition.	Changes from baseline to 6-months
Other	Perceived Cognition for Daily Life	PROMIS Applied Cognition: (General Concerns) This is a brief self-report of perceived difficulties with cognition for daily functioning. We will examine whether the intervention alters this subjective/perceived level of cognitive function. Scale 8-40. Lower score = less cognitive concerns	Changes from baseline to 6-months
Other	Black Identity	The Multidimensional Model of Racial Identity (MMRI) is a model that identifies four dimensions of African American racial identity: salience, centrality, regard, and ideology. We will examine whether racial identity acts as mediator to cognitive performance post-intervention.	6-month post
Other	Race-Related Stress	The Index of Race-Related Stress (IRRS) is one of the most commonly used measures to assess race-related stress among Black Americans. We will examine whether racial identity acts as mediator to cognitive performance post-intervention.	6-month post
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