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

Primary Purpose

Alzheimer Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Music

Dance Classes

About this trial

This is an interventional prevention trial for Alzheimer Disease focused on measuring Alzheimer Risk, Aging, Dance

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Wake Forest School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Dance 3 Times Weekly (3xD)

Dance 2 Times Weekly (2xD)

Dance 1 Time Weekly (1xD)

Music Appreciation Classes (MAC)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Secondary Outcome Measures

Class Attendance

Percent attendance (number of classes attended divided by number of classes offered in that arm)

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.

Full Information

NCT ID

NCT05507905

First Posted

August 17, 2022

Last Updated

April 27, 2023

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05507905

Brief Title

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

Acronym

IGROOVE

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 24, 2023 (Actual)

Primary Completion Date

March 2027 (Anticipated)

Study Completion Date

March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

Alzheimer Risk, Aging, Dance

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dance 3 Times Weekly (3xD)

Arm Type

Experimental

Arm Description

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.

Arm Title

Dance 2 Times Weekly (2xD)

Arm Type

Experimental

Arm Description

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.

Arm Title

Dance 1 Time Weekly (1xD)

Arm Type

Experimental

Arm Description

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.

Arm Title

Music Appreciation Classes (MAC)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Music

Intervention Description

Music associated with dance forms in dance classes.

Intervention Type

Behavioral

Intervention Name(s)

Dance Classes

Intervention Description

Four Different dance forms taught for 6 weeks each

Primary Outcome Measure Information:

Title

Peak Oxygen Consumption (VO2)

Description

Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function.

Time Frame

Baseline

Title

Peak Oxygen Consumption (VO2)

Description

Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function.

Time Frame

Month 1

Title

Peak Oxygen Consumption (VO2)

Description

Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function.

Time Frame

Month 3

Title

Peak Oxygen Consumption (VO2)

Description

Assessed with Graded Exercise Test (GXT) Peak oxygen consumption, a marker of cardiorespiratory fitness (ml/kg/min) Shows effect on Cardio Respiratory Function.

Time Frame

Month 6

Title

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Description

Time Frame

Baseline

Title

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Description

Time Frame

Month 1

Title

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Description

Time Frame

Month 3

Title

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Description

Time Frame

Month 6

Secondary Outcome Measure Information:

Title

Class Attendance

Description

Percent attendance (number of classes attended divided by number of classes offered in that arm)

Time Frame

Week 24

Title

Exercise Self-Efficacy

Description

Time Frame

Baseline, Month 1, Month 3, Month 6

Other Pre-specified Outcome Measures:

Title

Expanded short physical performance battery (eSPPB)

Description

The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a maximum score of 3.0 where 3 is the best possible outcome.

Time Frame

Baseline, Month 1, Month 3, Month 6

Title

Gait Variability

Description

Assessed over 4m 3 times at usual pace and 3 times at fast pace using an instrumented mat (GAITRite System); it will provide data on the variability in these measures

Time Frame

Baseline, Month 1, Month 3, Month 6

Title

Postural Sway

Description

Center of pressure (millimeter squared) collected using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform.

Time Frame

Baseline, Month 1, Month 3, Month 6

Title

Timed Up and Go (TUG)

Description

The Timed Up and Go test is used to assess a person's mobility and requires both static and dynamic balance. Time in seconds that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.

Time Frame

Baseline, Month 1, Month 3, Month 6

Title

Overall physical activity

Description

Overall volumes of movement in minutes per day

Time Frame

Baseline, Month 1, Month 3, and Month 6

Title

Dance Self-Efficacy

Description

For dance arms only. Perceived confidence to engage in an individual's specific dance program over extended periods of time. Five items scored on a scale of 0-10. A total score will be generated by summing scores from all five items and dividing by 5, for a potential range of total scores from 0-10, where a higher score is better.

Time Frame

Baseline, Month 1, Month 3, Month 6

Title

Brief Psychological Needs Satisfaction and Frustration Scale (BPNSFS)--Satisfaction

Description

The BPNSFS yields overall scores on two scales: satisfaction and frustration. An overall score for satisfaction (total possible = 60, higher score is better) will be calculated.

Time Frame

Baseline, Month 1, Month 3, Month 6

Title

Brief Psychological Needs Satisfaction and Frustration Scale (BPNSFS)--Frustration

Description

The BPNSFS yields overall scores on two scales: satisfaction and frustration. . An overall score for frustration (total possible = 60, lower score is better) will be calculated.

Time Frame

Baseline, Month 1, Month 3, Month 6

Title

Magnetic Resonance Imaging (MRI)-Neuro imaging

Description

Grey matter volume (cm3); voxelwise freewater calculated from neurite orientation dispersion and density imaging (NODDI) image; from functional MRI (fMRI) graph theory analysis, global efficiency and modular structure

Time Frame

Baseline, Month 6

Title

Average Heart Rate

Description

Collected with chest-worn strap (beats per minute)

Time Frame

Weekly up through Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christina Hugenschmidt, PhD

Phone

336-713-4190

chugensc@wakehealth.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christina Hugenschmidt, PhD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest School of Medicine

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christina Hugenschmidt, PhD

Phone

336-713-4190

chugensc@wakehealth.edu

First Name & Middle Initial & Last Name & Degree

Christina Hugenschmidt, PhD

12. IPD Sharing Statement

Plan to Share IPD

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

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