NCT06425731

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
2mo left

Started Jul 2024

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2024Jul 2026

First Submitted

Initial submission to the registry

May 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

May 16, 2024

Last Update Submit

April 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oxygen uptake

    The rate of oxygen uptake during a 60-min dance session

    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).

Study Arms (2)

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.

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.

Other: No Intervention

Interventions

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.

Dance for PD (in-person)

No Intervention

Dance for PD (virtual/remote)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Aston K McCullough, PhD, MS, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants are prospectively assigned to participate in one of two study conditions that respectively seek to test different interventions and outcomes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 22, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations