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Heart Rate Variability in Duchenne Muscular Dystrophy During Computer Task

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ClinicalTrials.gov Identifier: NCT04607824
Recruitment Status : Completed
First Posted : October 29, 2020
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Carlos Bandeira de Mello Monteiro, University of Sao Paulo

Brief Summary:
HRV is attained using a Polar RS800CX. Then, evaluated through linear, non-linear and chaotic global techniques (CGT). Forty-five male subjects were included in the DMD group and age-matched with forty-five in the healthy Typical Development (TD) control group. They were assessed for twenty minutes at rest sitting, and then five minutes whilst performing the maze task on a computer.

Condition or disease Intervention/treatment
Duchenne Muscular Dystrophy Behavioral: Duchenne Muscular Dystrophy group Behavioral: Typical Development group

Detailed Description:

This is a cross-sectional study, where HR was recorded beat-to-beat (RR intervals) using the portable Polar RS800CX HR monitor (Polar Electro, Finland). HR was recorded before the onset and at the end of the five minutes of the computer maze paradigm task.

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).

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Computational Task in Duchenne Muscular Dystrophy: Involvement of Cardiac Autonomic Regulation.
Actual Study Start Date : March 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2020


Group/Cohort Intervention/treatment
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.
Behavioral: 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
Behavioral: Typical Development group
Assessment of heart rate variability at rest and during computational task in people with typical Development




Primary Outcome Measures :
  1. Heart Rate Variability behavior during computational task [ Time Frame: 1 day ]
    Linear, non-linear and complexity indices of heart rate variability will be assessed at rest and during computational task, in order to analyse it's behavior.



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Ages Eligible for Study:   9 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
45 individuals with DMD (convenience sample) and 45 age-matched healthy TD individuals participated in the trial.
Criteria

Inclusion Criteria:

  • DMD diagnoses was based on molecular methods and/or muscular protein expression.
  • TD age-matched with DMD.

Exclusion Criteria:

  • subjects with severely dilated myocardium.
  • subjects with other associated diseases.
  • individuals with inability to understand task instructions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04607824


Locations
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Brazil
Comitê de ética da Faculdade de Medicina da Universidade de São Paulo
São Paulo, SP, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Carlos BM Monteiro, Ph.D. University of Sao Paulo
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Responsible Party: Carlos Bandeira de Mello Monteiro, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04607824    
Other Study ID Numbers: 14508213.4.0000.0065
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Bandeira de Mello Monteiro, University of Sao Paulo:
Heart rate variability
Duchenne muscular dystrophy
Typically developed
Autonomic nervous system
Chaotic global techniques
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked