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

NCT05507905 | Active Not Recruiting DMC

• 2 other identifiers: IRB00086190R01AG076669
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Risk; Aging; Dance

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Class Attendance

  Week 24

• Exercise Self-Efficacy

  Baseline, Month 1, Month 3, Month 6

Other Outcomes (10)

• Expanded short physical performance battery (eSPPB)

  Baseline, Month 1, Month 3, Month 6

• Gait Variability

  Baseline, Month 1, Month 3, Month 6

• Postural Sway

  Baseline, Month 1, Month 3, Month 6

Study Arms (4)

Dance 3 Times Weekly (3xD)

EXPERIMENTAL

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

Dance 2 Times Weekly (2xD)

EXPERIMENTAL

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

Dance 1 Time Weekly (1xD)

EXPERIMENTAL

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

Music Appreciation Classes (MAC)

ACTIVE COMPARATOR

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

Interventions

Music BEHAVIORAL

Music associated with dance forms in dance classes.

Music Appreciation Classes (MAC)

Dance Classes BEHAVIORAL

Four Different dance forms taught for 6 weeks each

Dance 1 Time Weekly (1xD); Dance 2 Times Weekly (2xD); Dance 3 Times Weekly (3xD)

Eligibility Criteria

• Age: 62 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christina Hugenschmidt, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: IGROOVE will randomize 200 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.

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 19, 2022
• Study Start: April 24, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)