An interventional study of Music and Dance Classes in Alzheimer Disease, sponsored by Wake Forest University Health Sciences. Active, not recruiting at 1 site in United States. Open to participants aged 62 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Prevention
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.
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.
3,681 studies on the registry are indexed under Alzheimer Disease; 875 are open to participants now.
This study's enrollment of 165 is above the median of 70 across 2,809 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
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
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
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
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
Music associated with dance forms in dance classes.
Four Different dance forms taught for 6 weeks each
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 6
Class Attendance
Percent attendance (number of classes attended divided by number of classes offered in that arm)
Time frame: 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.
Time frame: Baseline, Month 1, Month 3, Month 6
Expanded short physical performance battery (eSPPB)
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
Gait Variability
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
Postural Sway
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
Timed Up and Go (TUG)
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
Overall physical activity
Overall volumes of movement in minutes per day
Time frame: Baseline, Month 1, Month 3, and Month 6
Dance Self-Efficacy
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
Brief Psychological Needs Satisfaction and Frustration Scale (BPNSFS)--Satisfaction
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
Brief Psychological Needs Satisfaction and Frustration Scale (BPNSFS)--Frustration
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
Magnetic Resonance Imaging (MRI)-Neuro imaging
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
Average Heart Rate
Collected with chest-worn strap (beats per minute)
Time frame: Weekly up through Week 24
Plan to share: No
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Wake Forest University Health Sciences