Cardiorespiratory Parameters and Glycated Hemoglobin of Patients With Type 2 Diabetes After a Rehabilitation Program
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline of Glycated Hemoglobin at 3 months
研究概览
简要总结
Cardiovascular autonomic dysfunction reflects the pathophysiology of Diabetes Mellitus in this patient group favors an increase in morbidity and mortality related to cardiovascular events, and for this reason has been one of the most studied clinical entities.
Therefore this work aims to analyze the cardiorespiratory parameters and glycated hemoglobin after the commission of a rehabilitation program in patients with diabetes mellitus type 2.
The collection protocol is to check the heart rate, blood pressure, double product, Borg scale, variability heart rate and glycated hemoglobin of patients with type 2 diabetes This project this is an experimental study, the type randomized clinical trial on the hemodynamic response and glucose levels in patients with DM2 institutionalized in Acre Hospital Foundation submitted to one rehabilitation program consisting of aerobic and anaerobic exercises performed for 12 weeks in three weekly meetings, of 60 minutes each.
详细描述
Background: Built with evidence that makes it possible to work in cardiac rehabilitation programs in patients with type 2 diabetes with more security, guaranteeing them an improvement in cardiorespiratory fitness, the hemodynamic and glycemic variables, allowing them a better quality of life
Method/Design: The research instrument is applied before and after the practice of the proposed exercise program (consisting of aerobic and anaerobic exercises performed for 12 weeks in three weekly meetings, of 60 minutes each). The instrument is based on the following collection protocol: assessment of BP, HR, Borg scale, respiratory rate (RR), oxygen saturation (SAT), the DP calculation and will be carried out the examination to check HbA1C Will be performed for 12 weeks in three weekly meetings, of 60minutes each, in total of 36 sessions with antecipated 60 pacients splited in 2 groups "Control" and "intervention"
Discussion: Correlate the variability of heart rate behavior and glycated hemoglobin after the exercise program; To demonstrate the possible association between the change of the cardiorespiratory parameters according to the variation of glycated hemoglobin; Demonstrate the possibility of association between the variation of the cardiorespiratory parameters and glycated hemoglobin according to sex;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 Diabetes
- •Sedentary
- •Non-smoker
- •with medical prescription for rehabilitation program.
排除标准
- •Neurological disease
- •Acute heart failure
- •Morbid obesity
- •Atrial fibrillation
- •Sick sinus syndrome
- •Atrioventricular block grade II or III
- •Who used beta-blockers
- •Who used antiarrhythmic medication.
结局指标
主要结局
Change from baseline of Glycated Hemoglobin at 3 months
时间窗: three months
The HbA1c test counts the number of red blood cells that are glycated, that is, linked to a glucose molecule.
Change from baseline of Heart rate variability at 3 months
时间窗: three months
With a specific heart rate monitor, Heart Rate Variability (also called RR variability) is the measure of heart rate variation between each pair of heart beats at a given time interval. The results of the heart rate variability analysis are divided into two groups: time domain results and frequency domain results. They are numbers related to the "rhythm" in which the variations occur: VLF - Very Low Frequency: power contained in the range below 0.04Hz. LF - Low Frequency: power contained in the range of 0.04 to 0.15Hz. HF - High Frequency: power contained in the range of 0.15 to 0.4Hz. LF / HF: Ratio between LF and HF powers.
次要结局
- Change from baseline of pulse oximetry at every intervention session(three months)
- Change from baseline of subjective sensation of respiratory discomfort at every intervention session(three months)
- Change from baseline of Blood Pressure at every intervention session(three months)
- Change from baseline of the distance traveled at 3 months.(three months)
研究者
NATÁLIA DA SILVA FREITAS MARQUES
Principal Investigator, Clinical Research
União Educacional do Norte