Heart Rate Variability in Individuals With Duchenne Muscular Dystrophy
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|ClinicalTrials.gov Identifier: NCT04740554|
Recruitment Status : Completed
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
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.
|Condition or disease||Intervention/treatment|
|Duchenne Muscular Dystrophy||Behavioral: Duchenne Muscular Dystrophy group with Deflazacort Behavioral: Duchenne Muscular Dystrophy group with Prednisone/Predisolone Behavioral: Duchenne Muscular Dystrophy group without Corticosteroids therapy Behavioral: Control Group Typically Developing|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Characterization of Heart Rate Variability in Individuals With Duchenne Muscular Dystrophy - Influence of Corticosteroids and Betablockers|
|Actual Study Start Date :||March 1, 2013|
|Actual Primary Completion Date :||September 1, 2014|
|Actual Study Completion Date :||February 1, 2015|
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
Subjects with duchenne muscular dystrophy undergoing drug therapy 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
Subjects with duchenne muscular dystrophy undergoing drug therapy with Prednisona/Predinisolone
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 with duchenne muscular dystrophy without the use of corticosteroid drug 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
Control group with tipical development.
- Heart Rate Variability in adolescents with Duchenne Muscular Dystrophy undergoing therapy with corticosteroids [ Time Frame: One day ]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.
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): NCT04740554
|Principal Investigator:||Talita D da Silva, Ph.D.||Universidade Federal de São Paulo|