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Heart Rate Variability in Individuals With Duchenne Muscular Dystrophy

NCT04740554 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-02-05

No results posted yet for this study

Summary

A cross-sectional study was carried out, in which 40 boys, aged 11 to 18 years, were evaluated. The recruitment of groups was carried out at the neuromuscular disease outpatient clinic of the Federal University of São Paulo (UNIFESP). The recruited individuals were divided into 4 groups, namely: DMD that used deflazacort (DMD-D); DMD that used Prednisone/Prednisolone (DMD-P); DMD Control with no corticoid use (DMD-C) and Controls with typical development (CTD). The protocol was applied during the evaluation that was carried out at outpatient follow-up visits.

To assess the functionality of each patient, the Vignos scales were used to characterize the sample and the Motor Function Measure (MFM) for association with HRV indices.

All heart rate records were performed using a cardiofrequencymeter (V800, Polar). After placing the brace and monitor, the individuals were placed in the supine position and remained at rest spontaneously breathing for 25 minutes. For HRV analysis, indexes obtained by linear methods, in the domain of time and frequency, and non-linear methods were used.

Conditions

Interventions

BEHAVIORAL

Duchenne Muscular Dystrophy group with Deflazacort

Subjects with duchenne muscular dystrophy undergoing drug therapy with Deflazacort

BEHAVIORAL

Duchenne Muscular Dystrophy group with Prednisone/Predisolone

Subjects with duchenne muscular dystrophy undergoing drug therapy with Prednisona/Predinisolone

BEHAVIORAL

Duchenne Muscular Dystrophy group without Corticosteroids therapy

Control group with duchenne muscular dystrophy without the use of corticosteroid drug therapy.

BEHAVIORAL

Control Group Typically Developing

Control group with tipical development.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Talita D da Silva, Ph.D. · Universidade Federal de São Paulo

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-01
Primary Completion
2014-09-01
Completion
2015-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04740554 on ClinicalTrials.gov