Comparison Of Breathing Exercises and Auricular Vagus Nerve Stimulation Effects On Autonomic Nervous System Activity and Respiratory Functions In Healthy Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Pulmonary Function. Forced vital capacity (FVC)
研究概览
简要总结
Introduction: Vagal modulation is achieved directly by transcutaneous auricular vagus nerve stimulation, whereas breathing exercises stimulate arterial baroreceptors. In this study, we aimed to compare these two methods, which have similar effects.
Methods: 88 healthy participants aged 18-35 were randomly divided into breathing exercises (Group BE) and vagus stimulation (Group VNS). Thoracic expansion exercise was performed in the BE group. In the VNS group, biphasic electrical stimulation was applied to both ears with a pulse width of 300 microseconds, frequency of 10 Hz, and 20 minutes. Pulmonary function tests were measured on the first and last day. Heart rate, systolic and diastolic blood pressure, RMSSD, PNN50, LF/HF, LF Power, and HF Power values were measured before and after each of the ten sessions for both groups.
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
- Single (Participant)
盲法说明
The 88 volunteer cases were divided into two groups by randomization. By randomization, according to the order of participation in the study, odd-numbered people (such as first, third, fifth) were included in the breathing exercises group (Group BE); even-numbered people (such as second, fourth, sixth) were included in the vagus nerve stimulation group (Group VNS). After randomization, 44 cases in Group BE and 44 cases in Group VNS were evaluated. All participants completed the study.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals between the ages of 18 and 35,
- •without orthopedic disability,
- •without any chronic disease and regular medication use,
- •who had not smoked for the last year,
- •who had no problems in reading, writing, or comprehension were included in our study.
排除标准
- •active or chronic respiratory diseases and communication problems because they may adversely affect pulmonary function testing
结局指标
主要结局
Pulmonary Function. Forced vital capacity (FVC)
时间窗: pre-intervention, immediately after-intervention
Participants in both groups underwent pulmonary function test evaluation on the first and last day. Since the study was conducted in healthy individuals, it was deemed appropriate to look at the pulmonary function test before and after exertion to see possible changes. Medwelt SP10 spirometer was used for pulmonary function tests in our study. Each individual was measured in a sitting position using a separate mouthpiece.
Autonomic nervous system activity
时间窗: pre-intervention, immediately after-intervention
Autonomic measurements of each individual participating in the study before and after the intervention were performed with heart rate variability parameters. For this purpose, the Elite HRV device was used. The device has a finger sensor and an application compatible with the phone. Elite HRV application is a software that can synchronize with a personal monitor by collecting peak-to-peak intervals for instant analysis of pulse rate variability (PRV). In addition to all these assessments, blood pressure measurements of the participants were also evaluated using an Omron M2 electronic sphygmomanometer on the right arm.
Pulmonary Function. Forced expiratory volume in the first second (FEV1)
时间窗: pre-intervention, immediately after-intervention
Participants in both groups underwent pulmonary function test evaluation on the first and last day. Since the study was conducted in healthy individuals, it was deemed appropriate to look at the pulmonary function test before and after exertion to see possible changes. Medwelt SP10 spirometer was used for pulmonary function tests in our study. Each individual was measured in a sitting position using a separate mouthpiece.
次要结局
未报告次要终点
研究者
gulay karacaoglu
Doctor
Istanbul Medipol University Hospital