Rhythm Experience and Africana Culture Trial II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Flanker Performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 coronavirus disease (COVID-19).
排除标准
- •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).
结局指标
主要结局
Flanker Performance
时间窗: Changes from baseline to 6-months
A Flanker Inhibitory Control and Attention task will be administered at baseline, and then following the intervention (6 months). The main outcome from this task is the computed score from the NIH Toolbox, which reflects the participant's ability to inhibit responses to irrelevant information while focusing attention on a target stimulus. In each trial, participants make a directional response to a center arrow when the flanking arrows are arranged in congruent vs. incongruent direction from the center stimulus. The computed score combines accuracy and reaction time into a single performance metric, ranging from 0 to 10, with higher values indicating better performance. Group differences will be tested on this outcome.
Flanker Performance
时间窗: Changes from baseline to 6-months
A Flanker Inhibitory Control and Attention task will be administered at baseline, and then following the intervention (6 months). The main outcome from this task is the computed score from the NIH Toolbox, which reflects the participant's ability to inhibit responses to irrelevant information while focusing attention on a target stimulus. In each trial, participants make a directional response to a center arrow when the flanking arrows are arranged in congruent vs. incongruent direction from the center stimulus. The computed score combines accuracy and reaction time into a single performance metric, ranging from 0 to 10, with higher values indicating better performance. Group differences will be tested on this outcome.
次要结局
- Hippocampal Volume (mm3)(Changes from baseline to 6-months)
研究者
Kirk Erickson, PhD
Professor
University of Pittsburgh