Heart Rate Variability in Individuals With Duchenne Muscular Dystrophy

NCT04740554 | Completed

• 1 other identifier: 09942913.4.0000.5505
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Duchenne Muscular Dystrophy

Keywords

Muscular Dystrophy, Duchenne; Prednisone; Deflazacort

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability in adolescents with Duchenne Muscular Dystrophy undergoing therapy with corticosteroids

  Heart rate variability indices at rest in adolescents with duchenne muscular dystrophy will be analyzed, which will be divided into the following groups: Under the use of Deflazacort, Predinisone / Predinisolone and without the use of corticosteroids, in addition to the analysis of a control group with typical development.

  One day

Study Arms (4)

Duchenne Muscular Dystrophy group with Deflazacort

Individuals Duchenne Muscular Dystrophy, with age 11 to 18 years which make use of deflazacort.

Behavioral: Duchenne Muscular Dystrophy group with Deflazacort

Duchenne Muscular Dystrophy group with Prednisone/Predisolone

Individuals Duchenne Muscular Dystrophy, with age 11 to 18 years which make use of Prednisone/Predinisolone.

Behavioral: Duchenne Muscular Dystrophy group with Prednisone/Predisolone

Duchenne Muscular Dystrophy group without Corticosteroids therapy

Individuals Duchenne Muscular Dystrophy, with age 11 to 18 years which don't use of corticosteroids.

Behavioral: Duchenne Muscular Dystrophy group without Corticosteroids therapy

Control Group Typically Developing

Individuals with typical development age 11 to 18 years which don't use of corticosteroids.

Behavioral: Control Group Typically Developing

Interventions

Duchenne Muscular Dystrophy group with Deflazacort BEHAVIORAL

Subjects with duchenne muscular dystrophy undergoing drug therapy with Deflazacort

Duchenne Muscular Dystrophy group with Deflazacort

Duchenne Muscular Dystrophy group with Prednisone/Predisolone BEHAVIORAL

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

Duchenne Muscular Dystrophy group with Prednisone/Predisolone

Duchenne Muscular Dystrophy group without Corticosteroids therapy BEHAVIORAL

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

Duchenne Muscular Dystrophy group without Corticosteroids therapy

Control Group Typically Developing BEHAVIORAL

Control group with tipical development.

Control Group Typically Developing

Eligibility Criteria

• Age: 11 Years - 18 Years
• Gender Eligibility Details: It is a disease that affects only male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

30 boys with Duchenne Muscular Dystrophy and 10 typically developing boys aged 11 to 18 years.

You may qualify if:

• Individuals diagnosed with DMD confirmed by molecular method and / or by protein expression of skeletal muscle.
• Individuals undergoing clinical follow-up at the outpatient clinic for neuromuscular diseases at the Federal University of São Paulo (UNIFESP)
• Individuals who had authorization from their parents or guardians to participate in the study

You may not qualify if:

• Patients with cardiac arrhythmias.
• Patients with atrioventricular block.
• Patients with congenital anomalies such as congenital heart defects, pulmonary deformity.
• Patients using drugs that interfere with ANS, such as antiarrhythmic agents and drugs for the treatment of diabetes mellitus, such as insulin.

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

deflazacort; Prednisone

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Talita D da Silva, Ph.D.

  Universidade Federal de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share