Clinical trial NCT05507905: Effects of Dance and Music Appreciation on Brain Health and Fitness in People at Risk for Alzheimer's Disease
Official title: Establishing the Optimal Frequency of Dance Movement for Neurocognitive and Physical Outcomes in People at Risk of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer Risk
Aging
Dance
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-08-19
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peak Oxygen Consumption (VO2)
timeFrame: Baseline
measure: Peak Oxygen Consumption (VO2)
timeFrame: Month 1
measure: Peak Oxygen Consumption (VO2)
timeFrame: Month 3
measure: Peak Oxygen Consumption (VO2)
timeFrame: Month 6
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Baseline
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Month 1
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Month 3
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Month 6
Secondary outcomes:
measure: Class Attendance
timeFrame: Week 24
measure: Exercise Self-Efficacy
timeFrame: Baseline, Month 1, Month 3, Month 6
Other outcomes:
measure: Expanded short physical performance battery (eSPPB)
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: Gait Variability
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: Postural Sway
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: Timed Up and Go (TUG)
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: Overall physical activity
timeFrame: Baseline, Month 1, Month 3, and Month 6
measure: Dance Self-Efficacy
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: Brief Psychological Needs Satisfaction and Frustration Scale (BPNSFS)--Satisfaction
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: Brief Psychological Needs Satisfaction and Frustration Scale (BPNSFS)--Frustration
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: Magnetic Resonance Imaging (MRI)-Neuro imaging
timeFrame: Baseline, Month 6
measure: Average Heart Rate
timeFrame: Weekly up through Week 24
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Christina Hugenschmidt, PhD
role: PRINCIPAL_INVESTIGATOR
References: