- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05507905
Effects of Dance and Music Appreciation on Brain Health and Fitness in People at Risk for Alzheimer's Disease (IGROOVE)
April 27, 2023 updated by: Wake Forest University Health Sciences
Establishing the Optimal Frequency of Dance Movement for Neurocognitive and Physical Outcomes in People at Risk of Alzheimer's Disease
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Four Different dance forms taught for 6 weeks each
|
Experimental: 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.
|
Four Different dance forms taught for 6 weeks each
|
Experimental: 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.
|
Four Different dance forms taught for 6 weeks each
|
Active Comparator: 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.
|
Music associated with dance forms in dance classes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Oxygen Consumption (VO2)
Time Frame: Baseline
|
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)
Time Frame: 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.
|
Month 1
|
Peak Oxygen Consumption (VO2)
Time Frame: 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.
|
Month 3
|
Peak Oxygen Consumption (VO2)
Time Frame: 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.
|
Month 6
|
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame: 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.
|
Baseline
|
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame: 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.
|
Month 1
|
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame: 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.
|
Month 3
|
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame: 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.
|
Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Class Attendance
Time Frame: Week 24
|
Percent attendance (number of classes attended divided by number of classes offered in that arm)
|
Week 24
|
Exercise Self-Efficacy
Time Frame: Baseline, Month 1, Month 3, Month 6
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expanded short physical performance battery (eSPPB)
Time Frame: Baseline, Month 1, Month 3, Month 6
|
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.
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Baseline, Month 1, Month 3, Month 6
|
Gait Variability
Time Frame: Baseline, Month 1, Month 3, Month 6
|
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
|
Baseline, Month 1, Month 3, Month 6
|
Postural Sway
Time Frame: Baseline, Month 1, Month 3, Month 6
|
Center of pressure (millimeter squared) collected using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform.
|
Baseline, Month 1, Month 3, Month 6
|
Timed Up and Go (TUG)
Time Frame: Baseline, Month 1, Month 3, Month 6
|
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.
|
Baseline, Month 1, Month 3, Month 6
|
Overall physical activity
Time Frame: Baseline, Month 1, Month 3, and Month 6
|
Overall volumes of movement in minutes per day
|
Baseline, Month 1, Month 3, and Month 6
|
Dance Self-Efficacy
Time Frame: Baseline, Month 1, Month 3, Month 6
|
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.
|
Baseline, Month 1, Month 3, Month 6
|
Brief Psychological Needs Satisfaction and Frustration Scale (BPNSFS)--Satisfaction
Time Frame: Baseline, Month 1, Month 3, Month 6
|
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.
|
Baseline, Month 1, Month 3, Month 6
|
Brief Psychological Needs Satisfaction and Frustration Scale (BPNSFS)--Frustration
Time Frame: Baseline, Month 1, Month 3, Month 6
|
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.
|
Baseline, Month 1, Month 3, Month 6
|
Magnetic Resonance Imaging (MRI)-Neuro imaging
Time Frame: Baseline, Month 6
|
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
|
Baseline, Month 6
|
Average Heart Rate
Time Frame: Weekly up through Week 24
|
Collected with chest-worn strap (beats per minute)
|
Weekly up through Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2023
Primary Completion (Anticipated)
March 1, 2027
Study Completion (Anticipated)
March 1, 2027
Study Registration Dates
First Submitted
August 17, 2022
First Submitted That Met QC Criteria
August 17, 2022
First Posted (Actual)
August 19, 2022
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 27, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00086190
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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