Alzheimer DiseaseIGROOVENCT05507905
Effects of Dance and Music Appreciation on Brain Health and Fitness in People at Risk for Alzheimer's Disease
A study testing Music and Dance Classes in people with Alzheimer Disease, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 62 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Music and Dance Classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 62 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: 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 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.
Read the detailed description
IGROOVE is an individually randomized group treatment trial that is controlled and single-blind. It will enroll adults aged 62 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.
- Conditions
- Alzheimer Disease
- Being tested
- Music, Dance Classes
- Keywords
- Alzheimer Risk, Aging, Dance
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Music associated with dance forms in dance classes.
Dance ClassesBehavioural
Four Different dance forms taught for 6 weeks each
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6
Secondary outcomes (2)
Class Attendance
Percent attendance (number of classes attended divided by number of classes offered in that arm)
Measured: 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.
Measured: Baseline, Month 1, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start24 Apr 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Christina Hugenschmidt, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507905
- Sponsor's protocol ID
- IRB00086190
- Other IDs
- R01AG076669
- Acronym
- IGROOVE
- Status last verified
- Mar 2026
- First submitted
- 17 Aug 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Optimal Frequency of Dance Movement for Neurocognitive and Physical Outcomes in People at Risk of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05507905
- Acronym / sponsor ID
- IGROOVE / IRB00086190
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Risk, Aging, Dance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
IGROOVE is an individually randomized group treatment trial that is controlled and single-blind. It will enroll adults aged 62 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dance 3 Times Weekly (3xD) | Experimental | Behavioral: Dance ClassesParticipants 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. |
| Dance 2 Times Weekly (2xD) | Experimental | Behavioral: Dance ClassesParticipants 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. |
| Dance 1 Time Weekly (1xD) | Experimental | Behavioral: Dance ClassesParticipants 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. |
| Music Appreciation Classes (MAC) | Active comparator | Behavioral: MusicIn the MAC, the music associated with that dance form will be used as the subject for classes and will also change every 6 weeks. |
Who may qualify
- Ages
- 62 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicMusic associated with dance forms in dance classes. | Behavioural | Music Appreciation Classes (MAC) |
| Dance ClassesFour Different dance forms taught for 6 weeks each | Behavioural | Dance 1 Time Weekly (1xD), Dance 2 Times Weekly (2xD), Dance 3 Times Weekly (3xD) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Class Attendance
Time frame: Week 24
Exercise Self-Efficacy
Time frame: Baseline, Month 1, Month 3, Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Hugenschmidt, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Dance Classes in people with Alzheimer Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Oxygen Consumption (VO2) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.