Viewing Study NCT06425731



Ignite Creation Date: 2024-06-16 @ 11:48 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06425731
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-03
First Post: 2024-05-16

Brief Title: Dance and Energy Expenditure Among Adults With Parkinsons
Sponsor: Northeastern University
Organization: Northeastern University

Study Overview

Official Title: Characterizing Dance-related Physical Activity Behaviors Among Adults Living With Parkinsons Disease for Automated Analyses of Energy Expenditure
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The first purpose of the study is to develop and test new methods for quantifying dance among adults with a diagnosis of Parkinsons 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 Parkinsons and individual-level factors like the kinds of routine activities one does beyond dancing and ones 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 Parkinsons 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: Parkinsons 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 age5 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 44-60 metabolic equivalent METs ie 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 N30 Dance for PD participants in a community-based setting To test this aim 2D3D 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

2 Characterize the relative intensity of Dance for PD sessions within home-based settings To test this aim N30 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None