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临床试验/NCT06796101
NCT06796101已完成不适用

The Effect of Auricular Vagus Nerve Stimulation and Controlled Breathing Exercises on Performance and Autonomic Nervous System in Healthy Individuals

Bahçeşehir University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年7月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Performance

研究概览

简要总结

There are many studies in the literature on transcutaneous vagus nerve stimulation (VNS) and controlled breathing exercises (CBE), but there are limited studies examining the effects of both interventions on performance and the autonomic nervous system.

The investigators aim to contribute to the literature by examining the effects of VNS and CBE on performance and the autonomic nervous system in moderately physically active individuals and their superiority over each other.

详细描述

The sympathetic and parasympathetic divisions of the autonomic nervous system affect the function of many organs, glands, and involuntary muscles in the body. The sympathetic and parasympathetic nervous systems often play opposing roles in the body, one is suppressed when the other increases activity. With the beginning of exercise or sports activity, sympathetic activity in the body increases and after a certain period reaches a plateau value at maximum activity. With the end of sports activity, the suppressed parasympathetic activity increases, and the sympathetic system returns to its resting state over time.

Low sympathetic activity and/or high parasympathetic activity and low heart rate before training or exercise can be considered as performance indicators. It also indicates that recovery from the previous training or exercise is adequate. Parasympathetic system activation continues for up to 48 hours after exercise. If the exercise is intense and persistent, parasympathetic system activity can last up to 72 hours. In addition, due to the increase in anaerobic respiratory rate during exercise, there may be decreases in parasympathetic reactivation.

Transcutaneous vagus nerve stimulation (VNS) can affect cardiovascular parameters both at rest and during exercise. VNS improves autonomic modulation and positively reduces pain and fatigue associated with cycling exercise. On the other hand, VNS is particularly useful in reducing pain and fatigue during and after competition.

Slow breathing modulates the activity of the vagus nerve. Controlled breathing exercises (CBE) directly affect the respiratory rate, which can lead to faster physiological and psychological calming effects by increasing vagal tone during slow expiration. CBE increase heart rate variability in healthy participants.

The investigators aim to contribute to the literature by examining the effects of VNS and CBE on performance and the autonomic nervous system in moderately physically active individuals and their superiority over each other.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Individuals with a moderate level of physical activity according to the International Physical Activity Scale
  • No orthopedic obstacle to exertion
  • Being male

排除标准

  • Having any active or chronic disease
  • Having cooperation problems
  • Using regular medication for any chronic condition within the last year
  • Being a smoker
  • Having had heart surgery
  • Having had surgery on the respiratory system

结局指标

主要结局

Performance

时间窗: Baseline and 2 weeks.

Individuals will be taken to the treadmill and the distance and time taken until the maximum heart rate value reaches 80% will be recorded. The maximum heart rate value will be determined for each individual according to the formula 220-age. The participants will walk at a speed of 2 km/h for 1 minute, at a speed of 4 km/h for 1 minute and at a speed of 6 km/h, and the distance and time taken until the maximum heart rate reaches 80% will be recorded. In the termination phase of the run, a walk will be performed at a speed of 4 km/h for 1 minute and a speed of 2 km/h for 1 minute and will be completed.

Autonomic nervous system

时间窗: Baseline and 2 weeks.

Heart rate change will be evaluated for the evaluation of the autonomic nervous system. Polar H9 heart rate sensor chest strap and wristwatch will be used to measure analytical heart rate change. During the assessment, the participant will be seated in a chair and the Polar system chest strap will be placed just above the sternum, and ultrasound gel will be used to increase the sensor's conductivity. This method is valid with an electrocardiogram. Heart rate variability parameters such as RMSSD, LF, and HF will be measured.

次要结局

  • International Physical Activity Questionnaire(Baseline)
  • Modified Borg Scale(Baseline and 2 weeks.)
  • Perceived Stress Scale(Baseline and 2 weeks.)
  • Blood Pressure Measurement(Baseline and 2 weeks.)
  • Pulse(Baseline and 2 weeks.)
  • Oxygen Saturation(Baseline and 2 weeks.)

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Okan Sahin

Principal Investigator, PT (Physiotherapist), MSc

Bahçeşehir University

研究点 (1)

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