Parkinson DiseaseNCT06425731
Dance and Energy Expenditure Among Adults With Parkinson's
A study testing Fasting in people with Parkinson Disease, run by Northeastern University at 1 site in United States.
Trial summary
The first purpose of the study is to develop and test new methods for quantifying dance among adults with a diagnosis of Parkinson's using various kinds of cameras, wearable activity monitors, and questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 31 Jul 2026
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (18-85 years old)
- Diagnosis of idiopathic PD (as confirmed by a neurologist), who are at a Hoehn and Yahr stage <=3 (i.e., physically independent, some postural instability, mild to moderate bilateral involvement or less severe symptoms; Bhidayasiri et al., 2012), and who are
- enrolled in Dance for PD® classes at the time of recruitment as a participant
Who cannot join
- Adults with a score of >3 on the Hoehn \& Yahr scale (i.e., those presenting with severely disabling disease, but still able to walk or stand unassisted or those who are confined to a bed or wheelchair unless aided; Bhidayasiri et al., 2012)
- history of a prior neurological condition that is not PD, including epilepsy
- pregnant or trying to become pregnant
- those with contraindications to exercise as determined by the Physical Activity Readiness Questionnaire for Everyone (PARQ+)
- currently smoke cigarettes or use tobacco products
- have a pacemaker or other implanted medical device
Show all 14Show fewer
- have been hospitalized due to a psychological disorder within the last 5 years
- have a respiratory disease (including chronic obstructive pulmonary disease- COPD, asthma, pulmonary high blood pressure)
- have a metabolic condition (including type 1 diabetes, type 2 diabetes, pre-diabetes, chronic kidney disease, or liver problems)
- have a kidney condition, a heart condition, history of stroke or cancer
- experienced a blackout, fainted, or lost consciousness as a result of a head injury or had diagnosed concussion within the last 12 months
- take a medication that affects cardiovascular responses to exercise
- prospective participants with a diagnosis of PD who score < 17 on the Telephone Interview for Cognitive Status (TICS-30)
- currently residing outside of the United States
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northeastern University
Boston, Massachusetts, 02115
Gregory Cloutier, 617-373-8009, g.cloutier@northeastern.edu
Aston K McCullough, PhD, MS, MA
About this study
Official title: Characterizing Dance-related Physical Activity Behaviors Among Adults Living With Parkinson's Disease for Automated Analyses of Energy Expenditure
The first purpose of the study is to develop and test new methods for quantifying dance among adults with a diagnosis of Parkinson's using various kinds of cameras, wearable activity monitors, and questionnaires. The second reason we are conducting the study is to better understand the relationship between the intensity of dance classes specifically designed for adults with Parkinson's and individual-level factors like the kinds of routine activities one does beyond dancing and one's health status.
Participants in the study may be asked to engage in any of the following activities:
Read more
- complete a small number of assessments on their physical and cognitive functioning
- complete their routine group-based dance classes, specifically designed for adults with a diagnosis of Parkinson's, while being recorded
Depending upon the group that a participant joins, one may also be asked to:
- wear an activity monitor on their waist while engaged in their daily business as usual for nine (9) days
- complete an iDXA scan
- describe their perceptions on how the use of technology can integrated into their dancing
Read the detailed description
Parkinson's Disease (PD) is a neurodegenerative disorder that affects an estimated 1 million people in the United States, with the onset of symptoms typically occurring after the age of 50 years old. Adults living with PD experience motor impairments such as postural and gait instability, resting tremor, bradykinesia, and muscular rigidity; cognitive impairment, with an estimated 40% of individuals with PD presenting symptoms of at least mild cognitive impairment; and depression. Furthermore, PD symptom severity is known to increase with age.5 Research has shown that exposures to physical activity (PA) may delay the symptomatic progression of PD, and a recent meta-analysis revealed that engaging in dance, when compared to other modes of PA behavior, confers especial protective benefits across motor and cognitive outcomes. Surprisingly, the PA dose administered across some studies of dance has gone unmeasured and is therefore unknown. This is because various modes of dance are known to elicit different PA intensities, and PA intensity is further influenced by intra-individual factors. Because accurate measures of PA intensity are essential for determining an optimal PA dose within dose-response research, additional research that accurately quantifies the absolute and relative intensities of dance behaviors is needed to advance research on dance and health among adults living with PD.
Of the PD sequela that appear sensitive to dance exposures, studies have demonstrated protective benefits across motor symptoms, in addition to cognitive and mental health outcomes, after 3 - 12 months of participation in dance. However, little is known about the PA intensities of the dance behaviors that led to these reported outcomes, which therefore limits present understanding of the dose of dance required to yield reproducible results. Dance for PD (Collaborator: Leventhal), a codified dance program for adults living with PD, has been well-studied. During a Dance for PD class, participants dance, with music, while in a chair, standing, and while ambulatory. With wide acceptability, Dance for PD offers an ideal experimental paradigm in which to systematically monitor and quantify the intensity of dance behaviors among adults with PD.
Wearable sensors and cameras can be used to estimate PA intensities at individual and group levels. Building upon our prior work, our group is currently collecting camera, wearable sensor, and cardiopulmonary data in an ongoing clinical trial (PI: McCullough) to train algorithms that predict PA intensity during solo, free-form dance behavior. Preliminary results show healthy adults ages 18 to 75, with and without prior dance training, who intend to dance free-form at light-to-moderate intensities engage in dance at an average 4.4-6.0 metabolic equivalent (METs) (i.e., moderate-to-vigorous PA intensities). Age and body mass index are inversely associated with METs, and dancing with music is positively associated with METs. Dance for PD sessions include a range of structured and free-form activities performed with music; their codified framework affords participants multiple opportunities to modulate their PA behavior and intensity in community- and home-based settings. In view of our preliminary results that show multiple factors may impact the PA intensity of dance behavior, additional research is needed to better understand the dose of PA received during Dance for PD sessions. Therefore, we aim to:
1a) Train PA classifiers to detect the absolute and relative PA intensities of Dance for PD sessions within a cohort of N=30 Dance for PD participants in a community-based setting. To test this aim, 2D/3D cameras and triaxial accelerometers will be used to continuously record behavioral and kinematic data during group-based Dance for PD sessions. Indirect calorimeters and wireless heart rate sensors will be used to continuously monitor oxygen uptake and heart rate during multiple Dance for PD sessions. Oxygen uptake and heart rate data will serve as the ground truth, with signal features derived from the camera and wearable sensor data as key predictors. Hypothesis: Sensor-derived signal features can respectively be used to train algorithms to accurately classify the PA intensity of dance during Dance for PD sessions at both individual and group levels.
1b) Estimate associations between PA intensities observed during Dance for PD sessions and respective individual-level factors. To test this aim, estimates of the absolute and relative intensities of Dance for PD (aim 1) exposures will be respectively adjusted for body fat percentage, PD motor symptom severity, years since PD diagnosis, free-living activity, cognitive function, sex, and age. Hypothesis: Adjusting for clinical, demographic, anthropometric, and behavioral covariates will improve the accuracy of PA intensity classifiers.
- Characterize the relative intensity of Dance for PD sessions within home-based settings. To test this aim, N=30 adults will wear heart rate monitors while engaged in Dance for PD sessions at home. Heart rate data will be used to calculate the relative intensity of home-based Dance for PD sessions. Hypothesis: Engaging in Dance for PD at home will elicit light to moderate intensity physical activity bouts.
- Conditions
- Parkinson Disease
- Being tested
- Fasting, No Intervention
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
Participants (Dance for PD, in-person only) will engage in one of their routine weekly dance sessions while a portable indirect calorimeter is used for energy expenditure analysis. Before this session, participants will be asked to fast for at least 4-hours. In this way, participants in this study arm will engage in a self-controlled study design wherein they complete a 4-hour fast before engaging in an oxygen uptake assessment during their routine dance classes. During the 4-hour fasting period, participants will be asked to refrain from eating any food and drinking any beverages except for water.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Dance for PD (in-person) | Experimental | Participants will engage in Dance for PD classes in-person in their usual fashion, and within a group-based setting, for a total of three sessions. Oxygen uptake, heart rate and perceived exertion will be measured throughout specific Dance for PD classes. Receives: Other: Fasting |
| Dance for PD (virtual/remote) | Experimental | Participants will engage in Dance for PD classes online in their usual fashion, and within a group-based setting, for a total of two sessions. Heart rate and perceived exertion will be measured throughout the Dance for PD classes. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen uptake
The rate of oxygen uptake during a 60-min dance session
Measured: The outcome measure will be assessed after the intervention (i.e., after fasting: no food for at least 4 hours prior to a single dance session) and during the intervention (i.e., participants will continue to fast during the 60-minute dance session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jul 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are prospectively assigned to participate in one of two study conditions that respectively seek to test different interventions and outcomes.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Mark Morris Dance Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425731
- Sponsor's protocol ID
- 23-10-30
- Status last verified
- Apr 2026
- First submitted
- 16 May 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data set that will be generated in this study will contain identifiable information in the form of video data, which will be instrumental to the primary and secondary aims of the study. Though we do not plan to share any of the raw video or audio data, we may share signal features extracted from human activity detected in the video data; and we may share audio transcripts.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Dance-related Physical Activity Behaviors Among Adults Living With Parkinson's Disease for Automated Analyses of Energy Expenditure
- ClinicalTrials.gov ID
- NCT06425731
- Acronym / sponsor ID
- 23-10-30
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- Mark Morris Dance Group
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 22 May 2024 (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 first purpose of the study is to develop and test new methods for quantifying dance among adults with a diagnosis of Parkinson's using various kinds of cameras, wearable activity monitors, and questionnaires. The second reason we are conducting the study is to better understand the relationship between the intensity of dance classes specifically designed for adults with Parkinson's and individual-level factors like the kinds of routine activities one does beyond dancing and one's health status.
Participants in the study may be asked to engage in any of the following activities:
- complete a small number of assessments on their physical and cognitive functioning
- complete their routine group-based dance classes, specifically designed for adults with a diagnosis of Parkinson's, while being recorded
Depending upon the group that a participant joins, one may also be asked to:
- wear an activity monitor on their waist while engaged in their daily business as usual for nine (9) days
- complete an iDXA scan
- describe their perceptions on how the use of technology can integrated into their dancing
Detailed description
Parkinson's Disease (PD) is a neurodegenerative disorder that affects an estimated 1 million people in the United States, with the onset of symptoms typically occurring after the age of 50 years old. Adults living with PD experience motor impairments such as postural and gait instability, resting tremor, bradykinesia, and muscular rigidity; cognitive impairment, with an estimated 40% of individuals with PD presenting symptoms of at least mild cognitive impairment; and depression. Furthermore, PD symptom severity is known to increase with age.5 Research has shown that exposures to physical activity (PA) may delay the symptomatic progression of PD, and a recent meta-analysis revealed that engaging in dance, when compared to other modes of PA behavior, confers especial protective benefits across motor and cognitive outcomes. Surprisingly, the PA dose administered across some studies of dance has gone unmeasured and is therefore unknown. This is because various modes of dance are known to elicit different PA intensities, and PA intensity is further influenced by intra-individual factors. Because accurate measures of PA intensity are essential for determining an optimal PA dose within dose-response research, additional research that accurately quantifies the absolute and relative intensities of dance behaviors is needed to advance research on dance and health among adults living with PD.
Of the PD sequela that appear sensitive to dance exposures, studies have demonstrated protective benefits across motor symptoms, in addition to cognitive and mental health outcomes, after 3 - 12 months of participation in dance. However, little is known about the PA intensities of the dance behaviors that led to these reported outcomes, which therefore limits present understanding of the dose of dance required to yield reproducible results. Dance for PD (Collaborator: Leventhal), a codified dance program for adults living with PD, has been well-studied. During a Dance for PD class, participants dance, with music, while in a chair, standing, and while ambulatory. With wide acceptability, Dance for PD offers an ideal experimental paradigm in which to systematically monitor and quantify the intensity of dance behaviors among adults with PD.
Wearable sensors and cameras can be used to estimate PA intensities at individual and group levels. Building upon our prior work, our group is currently collecting camera, wearable sensor, and cardiopulmonary data in an ongoing clinical trial (PI: McCullough) to train algorithms that predict PA intensity during solo, free-form dance behavior. Preliminary results show healthy adults ages 18 to 75, with and without prior dance training, who intend to dance free-form at light-to-moderate intensities engage in dance at an average 4.4-6.0 metabolic equivalent (METs) (i.e., moderate-to-vigorous PA intensities). Age and body mass index are inversely associated with METs, and dancing with music is positively associated with METs. Dance for PD sessions include a range of structured and free-form activities performed with music; their codified framework affords participants multiple opportunities to modulate their PA behavior and intensity in community- and home-based settings. In view of our preliminary results that show multiple factors may impact the PA intensity of dance behavior, additional research is needed to better understand the dose of PA received during Dance for PD sessions. Therefore, we aim to:
1a) Train PA classifiers to detect the absolute and relative PA intensities of Dance for PD sessions within a cohort of N=30 Dance for PD participants in a community-based setting. To test this aim, 2D/3D cameras and triaxial accelerometers will be used to continuously record behavioral and kinematic data during group-based Dance for PD sessions. Indirect calorimeters and wireless heart rate sensors will be used to continuously monitor oxygen uptake and heart rate during multiple Dance for PD sessions. Oxygen uptake and heart rate data will serve as the ground truth, with signal features derived from the camera and wearable sensor data as key predictors. Hypothesis: Sensor-derived signal features can respectively be used to train algorithms to accurately classify the PA intensity of dance during Dance for PD sessions at both individual and group levels.
1b) Estimate associations between PA intensities observed during Dance for PD sessions and respective individual-level factors. To test this aim, estimates of the absolute and relative intensities of Dance for PD (aim 1) exposures will be respectively adjusted for body fat percentage, PD motor symptom severity, years since PD diagnosis, free-living activity, cognitive function, sex, and age. Hypothesis: Adjusting for clinical, demographic, anthropometric, and behavioral covariates will improve the accuracy of PA intensity classifiers.
- Characterize the relative intensity of Dance for PD sessions within home-based settings. To test this aim, N=30 adults will wear heart rate monitors while engaged in Dance for PD sessions at home. Heart rate data will be used to calculate the relative intensity of home-based Dance for PD sessions. Hypothesis: Engaging in Dance for PD at home will elicit light to moderate intensity physical activity bouts.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are prospectively assigned to participate in one of two study conditions that respectively seek to test different interventions and outcomes.
| Arm | Type | Receives |
|---|---|---|
| Dance for PD (in-person) | Experimental | Other: FastingParticipants will engage in Dance for PD classes in-person in their usual fashion, and within a group-based setting, for a total of three sessions. Oxygen uptake, heart rate and perceived exertion will be measured throughout specific Dance for PD classes. |
| Dance for PD (virtual/remote) | Experimental | Other: No InterventionParticipants will engage in Dance for PD classes online in their usual fashion, and within a group-based setting, for a total of two sessions. Heart rate and perceived exertion will be measured throughout the Dance for PD classes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18-85 years old)
- Diagnosis of idiopathic PD (as confirmed by a neurologist), who are at a Hoehn and Yahr stage <=3 (i.e., physically independent, some postural instability, mild to moderate bilateral involvement or less severe symptoms; Bhidayasiri et al., 2012), and who are
- enrolled in Dance for PD® classes at the time of recruitment as a participant
Key exclusion criteria (14 listed)
- Adults with a score of >3 on the Hoehn \& Yahr scale (i.e., those presenting with severely disabling disease, but still able to walk or stand unassisted or those who are confined to a bed or wheelchair unless aided; Bhidayasiri et al., 2012)
- history of a prior neurological condition that is not PD, including epilepsy
- pregnant or trying to become pregnant
- those with contraindications to exercise as determined by the Physical Activity Readiness Questionnaire for Everyone (PARQ+)
- currently smoke cigarettes or use tobacco products
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 |
|---|---|---|
| FastingParticipants (Dance for PD, in-person only) will engage in one of their routine weekly dance sessions while a portable indirect calorimeter is used for energy expenditure analysis. Before this session, participants will be asked to fast for at least 4-hours. In this way, participants in this study arm will engage in a self-controlled study design wherein they complete a 4-hour fast before engaging in an oxygen uptake assessment during their routine dance classes. During the 4-hour fasting period, participants will be asked to refrain from eating any food and drinking any beverages except for water. | Other | Dance for PD (in-person) |
| No InterventionNo Intervention | Other | Dance for PD (virtual/remote) |
Primary outcome
Oxygen uptake
Time frame: The outcome measure will be assessed after the intervention (i.e., after fasting: no food for at least 4 hours prior to a single dance session) and during the intervention (i.e., participants will continue to fast during the 60-minute dance session).
The rate of oxygen uptake during a 60-min dance session
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 13 Apr 2026.
- Individual participant dataSharing planned: Undecided. The data set that will be generated in this study will contain identifiable information in the form of video data, which will be instrumental to the primary and secondary aims of the study. Though we do not plan to share any of the raw video or audio data, we may share signal features extracted from human activity detected in the video data; and we may share audio transcripts.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Parkinson Disease, run by Northeastern University 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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 13 Apr 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?
Contact Aston K McCullough, PhD, MS, MA (6173738893, a.mccullough@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen uptake (time frame: The outcome measure will be assessed after the intervention (i.e., after fasting: no food for at least 4 hours prior to a single dance session) and during the intervention (i.e., participants will continue to fast during the 60-minute dance session).). 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 13 Apr 2026.