Heart Rate Variability in Duchenne Muscular Dystrophy During Computer Task

NCT04607824 | Completed

• 1 other identifier: 14508213.4.0000.0065
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Duchenne Muscular Dystrophy

Keywords

Heart rate variability; Duchenne muscular dystrophy; Typically developed; Autonomic nervous system; Chaotic global techniques

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability behavior during computational task

  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.

  1 day

Study Arms (2)

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

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

Interventions

Duchenne Muscular Dystrophy group BEHAVIORAL

Assessment of heart rate variability at rest and during computational task in people with Duchenne muscular dystrophy

Duchenne Muscular Dystrophy group

Typical Development group BEHAVIORAL

Assessment of heart rate variability at rest and during computational task in people with typical Development

Typical Development group

Eligibility Criteria

• Age: 9 Years - 21 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

45 individuals with DMD (convenience sample) and 45 age-matched healthy TD individuals participated in the trial.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Comitê de ética da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Carlos BM Monteiro, Ph.D.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 29, 2020
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

BR (1)