Autonomic and Hemodynamic Responses to Inspiratory Muscle Exercise in Pre Hypertensive and Hypertensive Individuals: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change from baseline blood pressure levels in 24 hours
研究概览
简要总结
This study aims to evaluate the autonomic and hemodynamic responses triggered by inspiratory muscle exercise in prehypertensive and hypertensive individuals. The reason that leads us to this study refers to clinical relevance for individuals with high blood pressure levels, since this type of exercise can act as a important nonpharmacological agent for arterial pressure control. In addition, this study aims to elucidate the mechanisms involved in cardiovascular responses to inspiratory muscle exercise and, consequently, provide safety in the prescription of these for this population.
详细描述
This is a randomized clinical trial, consisting of a convenience sample of patients from the Cardiology Department of the University Hospital (UH) of the Federal University of Juiz de Fora (FUJF). The patients will be invited to participate in the study and will receive information regarding the objectives and procedures of the study. In case of agreement with their inclusion in the study, they will sign a free and informed consent form.
The entire experiment will be carried out in the Physical Evaluation Laboratory of the UH-FUJF, by the researchers previously trained in the application of the protocol. The stages of the experimental protocol will be divided into three days as described below.
- 1st day of the experimental protocol (initial evaluation): medical historical, anthropometric evaluation, electrocardiographic monitoring at rest, evaluation of respiratory muscle strength and familiarization with the muscle training device. All volunteers will be instructed to refrain from taking caffeinated and alcoholic beverages for 24 h before the evaluation and to have a good night's sleep.
- 2nd and 3rd days of the experimental protocol: all volunteers will be randomly assigned to two exercise sessions (ES): Sham IME (no load) and moderate intensity IME (40% of MIP). Initially, the volunteers will perform a 10-minute supine rest for heartbeat collection and subsequent calculation of heart rate variability (HRV), blood pressure and forearm blood flow measurements and evaluation of the baroreflex system. In sequence the ES will be conducted with continuous monitoring of blood pressure, heart rate and subjective perception of effort through the Borg Scale. Immediately and until one hour after the ES, it will be measured forearm blood flow, blood pressure, heart rate and evaluated the baroreflex system and HRV in order to investigate the acute effect of ES. The volunteers will be monitored using an equipment capable of evaluating the outpatient measurement of blood pressure and electrocardiogram for 24 hours in order to investigate the chronic effect of ES.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of prehypertension (systolic blood pressure > 121-139 mmHg / diastolic blood pressure > 81-89 mmHg) and stage 1 hypertension (systolic blood pressure > 140-159 mmHg / diastolic blood pressure > 90-99 mmHg) with low to moderate cardiovascular risk
- •Do not use drugs to control blood pressure levels
- •Sedentary for at least 6 months
排除标准
- •Cardiovascular or respiratory diseases
- •Arrhythmias detected during electrocardiographic monitoring
- •Inability to perform the proposed protocol
研究组 & 干预措施
Inspiratory muscle exercise (IME)
Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 40% of maximal inspiratory pressure.
干预措施: IME (Other)
Sham IME
Participants will be submitted to inspiratory muscle exercise with the same equipment as the intervention group, but without a load generating resistance.
干预措施: Sham IME (Other)
结局指标
主要结局
Change from baseline blood pressure levels in 24 hours
时间窗: Baseline, 60 minutes and 24 hours post each intervention
Noninvasive hemodynamic monitoring and ambulatory blood pressure monitoring
次要结局
- Peripheral blood flow(Baseline and 60 minutes post each intervention)
- Autonomic nervous system(Baseline, 60 minutes and 24 hours post each intervention)
研究者
Lilian Pinto da Silva
Autonomic and Hemodynamic Responses to Inspiratory Muscle Exercise in Pre Hypertensive and Hypertensive Individuals
Federal University of Juiz de Fora