Establishing the Optimal Frequency of Dance Movement for Neurocognitive and Physical Outcomes in People at Risk of Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Peak Oxygen Consumption (VO2)
研究概览
简要总结
The purpose of this research study is to study the effects of dance movement and music on memory and cardiorespiratory fitness in older adults who are concerned about memory loss. The study aims to determine the optimal number of movement or music appreciation classes a week to support brain health and fitness. Participants will be people 62 years or older who are concerned about their memory, but do not yet have a diagnosis of cognitive impairment. If a participant is deemed qualified to participate, he/she will be placed into one of four groups and will attend 1, 2, or 3 group or music appreciation classes per week for 24 weeks (6 months). In addition to attending the group classes, participants will be asked to complete at least four study visits at Wake Forest Baptist Medical Center to complete various clinical assessments, including a brain MRI.
详细描述
IGROOVE is an individually randomized group treatment trial that is controlled and single-blind. It will enroll adults aged 62 years and older who are low-active, report a Cognitive Change Index score ≥16, do not meet criteria for mild cognitive impairment or dementia, are healthy enough to complete repeated graded exercise testing (GXT), and have no contraindications for magnetic resonance imaging (MRI). Randomization will be assessed to ensure equal distribution across study arms for these sex and body mass index (BMI) and will be stratified if necessary. New participants will be rolled into the intervention every 6 weeks. Data collection will take place at Atrium Wake Forest Baptist Health. Interventions will consist of dance classes or music appreciation classes designed and taught by local experts, and will take place in community sites, such as local dance studios, community centers, community gyms or churches. All intervention sites selected will be handicap accessible, well-lit, have appropriate flooring for safe dance movement, and access to sturdy chairs without wheels or arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 62 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cognitive Change Index score ≥16
- •Montreal Cognitive Assessment (MoCA) score ≥21
- •Cognitively normal
- •Low-active for past 6 months (<30 min, 3 days/week of exercise, including walking for exercise)
- •MRI compatible
- •Willing and able to complete exercise testing.
- •Has reliable transportation or is able to use transportation provided by the study.
- •English speaking (needed for group class participation)
排除标准
- •Unable or unwilling to attend intervention classes 1-3x/week
- •Current diagnosis of a major neurological disorder (Alzheimer's disease, Lewy body dementia, Frontotemporal dementia, Parkinson's disease, amyotrophic lateral sclerosis, etc.)
- •Unwilling or unable to provide consent for study participation.
- •Currently symptomatic or cortical stroke or stroke deemed exclusionary by the study physician. Reported or observed evidence of strokes on MRI will be reviewed on a case-by-case basis by the study physician to assess factors such as location, size, time since stroke, and residual symptoms.
- •Taking medication during the intervention times that could negatively influence safety
- •Current cancer treatment or other major medical problems that might independently affect cognition or movement or interfere with ability to attend intervention or study visits.
- •Chronic vertigo.
- •Enrolled in another interventional research study ≤3 months prior to beginning this study.
- •Hip fracture, hip or knee replacement, or spinal surgery in past 6 months.
- •Health contraindications for completing a graded exercise test and movement intervention, including uncontrolled hypertension (BP>200/110 mmHg), hypertriglyceridemia (TG>400 mg/dl), uncontrolled diabetes (HbA1c > 7.5), clinical evidence of anemia.
- •Self-reports regularly drinking > 14 alcoholic beverages a week or current illicit drug use.
- •Unable or unwilling to understand study procedures and comply with them for the duration of the study.
研究组 & 干预措施
Dance 1 Time Weekly (1xD)
Participants in this arm will attend a class 1 time a week for 24 weeks. During the 24 weeks, four different dance forms will be practiced. Each dance form will be taught for 6 weeks.
干预措施: Dance Classes (Behavioral)
Music Appreciation Classes (MAC)
In the MAC, the music associated with that dance form will be used as the subject for classes and will also change every 6 weeks.
干预措施: Music (Behavioral)
Dance 3 Times Weekly (3xD)
Participants in this arm will attend classes 3 times a week for 24 weeks. During the 24 weeks, four different dance forms will be practiced. Each dance form will be taught for 6 weeks.
干预措施: Dance Classes (Behavioral)
Dance 2 Times Weekly (2xD)
Participants in this arm will attend classes 2 times a week for 24 weeks. During the 24 weeks, four different dance forms will be practiced. Each dance form will be taught for 6 weeks.
干预措施: Dance Classes (Behavioral)
结局指标
主要结局
Peak Oxygen Consumption (VO2)
时间窗: Month 6
Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
时间窗: Month 6
Shows effect on Cognitive Function. Overall score from the RBANS; Average/Mild Impairment (standard scores of 70 or above), Moderate Impairment (standard scores from 55 to 69), and Severe Impairment (standard scores \<54) Scores range from 40 to 160.
Peak Oxygen Consumption (VO2)
时间窗: Baseline
Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function.
Peak Oxygen Consumption (VO2)
时间窗: Month 1
Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function.
Peak Oxygen Consumption (VO2)
时间窗: Month 3
Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
时间窗: Baseline
Shows effect on Cognitive Function. Overall score from the RBANS; Average/Mild Impairment (standard scores of 70 or above), Moderate Impairment (standard scores from 55 to 69), and Severe Impairment (standard scores \<54) Scores range from 40 to 160.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
时间窗: Month 1
Shows effect on Cognitive Function. Overall score from the RBANS; Average/Mild Impairment (standard scores of 70 or above), Moderate Impairment (standard scores from 55 to 69), and Severe Impairment (standard scores \<54) Scores range from 40 to 160.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
时间窗: Month 3
Shows effect on Cognitive Function. Overall score from the RBANS; Average/Mild Impairment (standard scores of 70 or above), Moderate Impairment (standard scores from 55 to 69), and Severe Impairment (standard scores \<54) Scores range from 40 to 160.
次要结局
- Exercise Self-Efficacy(Baseline, Month 1, Month 3, Month 6)
- Class Attendance(Week 24)