Characterization of Heart Rate Variability in Individuals With Duchenne Muscular Dystrophy - Influence of Corticosteroids and Betablockers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Heart Rate Variability in adolescents with Duchenne Muscular Dystrophy undergoing therapy with corticosteroids
研究概览
简要总结
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.
详细描述
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) with n=11; DMD that used Prednisone/Prednisolone (DMD-P), with n=9; DMD Control with no corticoid use (DMD-C), and n=10 and Controls with typical development (CTD) with n=10. The protocol was applied during the evaluation that was carried out at outpatient follow-up visits. Anthropometry was analyzed in 4 groups and functionality was assessed in 3 groups with DMD. 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.
Initially, the resting ECG was analyzed to verify the existence of sinus rhythm and to exclude individuals with arrhythmias and blocks. The measurements at rest were performed immediately before and after the HRV assessment, including systolic (SBP) and diastolic (DBP), heart rate (HR), Respiratory Rate (RF - blood pressure) to ensure that at the beginning and at the end of the collection FR remains between 9 - 24rpm, in the range of 0.15 - 0.40Hz) and partial oxygen saturation (SO2). Heart rate was recorded by the cardiofrequency meter (RS800CX, Polar). And the partial oxygen saturation by means of a digital oximeter (DX2010, Dixtal) connected to the participant's index finger or hallux, through a sensor of age-appropriate size, in room air. Hemoglobin saturation by oxygen was recorded after the first minute of stabilization, as the value that remains most constant during the second minute.
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.
In the time domain, for linear analyses, each normal RR interval (sinus beats) was verified during a certain time interval and, using statistical and non-linear methods, the translating indexes of fluctuations in the duration of the cardiac cycles were calculated. With this, the indices expressed in ms were obtained: SDNN (Standard deviation of the normal RR intervals recorded in a time interval); rMSSD (square root of the mean of the square of the differences between adjacent normal RR intervals in a time interval).
In the frequency domain, the spectral power density is more used, mainly when treating individuals in resting conditions. This analysis divides HRV into fundamental oscillatory components, which were used the main: High Frequency normalized unite (HFnu) component and Low Frequency normalized unite (LFnu) component. O algoritmo utilizado para a análise espectral foi a transformada rápida de Fourier - FFT (janela de 256 s com 50% de overlap).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 11 Years 至 18 Years(Child, Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Heart Rate Variability in adolescents with Duchenne Muscular Dystrophy undergoing therapy with corticosteroids
时间窗: 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.
次要结局
未报告次要终点
研究者
Talita Dias da Silva
Researcher
University of Sao Paulo
