Heart Rate Variability in Duchenne Muscular Dystrophy During Computer Task
NCT ID: NCT04607824
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2014-03-31
2020-06-30
Brief Summary
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Detailed Description
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The subjects were seated in a standard chair (walkers, TD group and DMD) or in their own wheelchair (non-walkers, DMD group), the Polar watch was positioned on the wrist. The analysis of HRV was possible through the recording of RR interval in two periods: the period of twenty minutes at seated rest, and then during the computer task for five minutes.
The computer task used a maze paradigm with one correct pathway that could be negotiated and ultimately solved. All participants were positioned comfortably and an evaluator responsible for instruction and annotation of data.
Each individual was instructed to walk the correct path with the digital character pawn (pointed on the screen by the evaluator) to the exit of the maze identified by an "x" (pointed on the screen by the evaluator). It was provided for the subjects, who used the arrow buttons on the keyboard, identified by up, down, right and left, using the dominant hand, with the arrows moving through a 20 x 20 cm maze. Participants were requested to complete the maze as fast as possible.
HRV analysis followed the guidelines published by the Task Force of the European Society of Cardiology and North American Society of Pacing and Electrophysiology. The RR intervals were recorded, and then were downloaded to the Polar Precision Performance program (v.3.0). This software enabled the visualization of HR and the extraction of a cardiac period (RR intervals series; the variation of beat-to-beat interval in milliseconds) file in ".txt" format. For analysis of HRV data at rest, we analyzed 1000 consecutive RR intervals, and for HRV analysis for the computational task, the number of consecutive RR intervals obtained was exactly 256 RR intervals. Digital filtering complemented by manual filtering was performed to eliminate artifacts and only series with greater than 95% of sinus beats were included in the study. HRV analysis was undertaken through linear, non-linear and chaotic global techniques (CGT).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Duchenne Muscular Dystrophy group
Forty-five male subjects were included in the Duchenne Muscular Dystrophy (DMD) group and they were assessed for twenty minutes at rest sitting, and then five minutes whilst performing the maze task on a computer.
Duchenne Muscular Dystrophy group
Assessment of heart rate variability at rest and during computational task in people with Duchenne muscular dystrophy
Typical Development group
Forty-five male subjects were included in the healthy Typical Development (TD) control group and they were assessed for twenty minutes at rest sitting, and then five minutes whilst performing the maze task on a computer
Typical Development group
Assessment of heart rate variability at rest and during computational task in people with typical Development
Interventions
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Duchenne Muscular Dystrophy group
Assessment of heart rate variability at rest and during computational task in people with Duchenne muscular dystrophy
Typical Development group
Assessment of heart rate variability at rest and during computational task in people with typical Development
Eligibility Criteria
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Inclusion Criteria
* TD age-matched with DMD.
Exclusion Criteria
* subjects with other associated diseases.
* individuals with inability to understand task instructions.
9 Years
21 Years
MALE
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Carlos Bandeira de Mello Monteiro
Associate Professor
Principal Investigators
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Carlos BM Monteiro, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Comitê de ética da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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14508213.4.0000.0065
Identifier Type: -
Identifier Source: org_study_id