Effects of Dance and Music Appreciation on Brain Health and Fitness in People at Risk for Alzheimer's Disease

Study Overview
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Brief Summary
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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 65 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.

Detailed Description
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IGROOVE is an individually randomized group treatment trial that is controlled and single-blind. It will enroll adults aged 65 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.

Official Title
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Establishing the Optimal Frequency of Dance Movement for Neurocognitive and Physical Outcomes in People at Risk of Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Behavioral: Music
* Behavioral: Dance Classes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: IGROOVE will randomize 160 participants meeting enrollment criteria in a 1:1:1:1 fashion to attend a music appreciation class or dance classes either 1x/week, 2x/week or 3x/week for 24 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dance 3 Times Weekly (3xD)<br>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. | Behavioral: Dance Classes<br>* Four Different dance forms taught for 6 weeks each<br>|
| Experimental: Dance 2 Times Weekly (2xD)<br>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. | Behavioral: Dance Classes<br>* Four Different dance forms taught for 6 weeks each<br>|
| Experimental: Dance 1 Time Weekly (1xD)<br>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. | Behavioral: Dance Classes<br>* Four Different dance forms taught for 6 weeks each<br>|
| Active Comparator: Music Appreciation Classes (MAC)<br>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. | Behavioral: Music<br>* Music associated with dance forms in dance classes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Oxygen Consumption (VO2) | Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function. | Baseline | 
| Peak Oxygen Consumption (VO2) | Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function. | Month 1 | 
| Peak Oxygen Consumption (VO2) | Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function. | Month 3 | 
| Peak Oxygen Consumption (VO2) | Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function. | Month 6 | 
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | 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. | Baseline | 
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | 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. | Month 1 | 
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | 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. | Month 3 | 
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | 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. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Class Attendance | Percent attendance (number of classes attended divided by number of classes offered in that arm) | Week 24 | 
| Exercise Self-Efficacy | Questionnaire that shows perceived confidence to engage in sufficient physical activity through accumulation over extended periods of time. The scale has a range of scores from 0-90. A higher number on the score represents a higher self-efficacy for exercise. | Baseline, Month 1, Month 3, Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Risk, Aging, Dance