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临床试验/NCT06985043
NCT06985043已完成不适用

The Effect of Vagus Nerve Stimulation on Lower Limb Muscle Strength and Balance in Nonelite Athletes

Bahçeşehir University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Muscle strenght

研究概览

简要总结

Clinical Trials (Non-Randomized Controlled) The aim of this study is to evaluate whether vagus nerve stimulation can improve neuromuscular and functional outcomes in non-elite athletes aged 18-35 years living in Istanbul.

The main questions it aims to answer are:

Does vagus nerve stimulation improve neuromuscular performance? Does it have a positive effect on functional performance? Researchers will compare the vagus nerve stimulation group to a control group to see if the intervention leads to significant improvements in neuromuscular and functional outcomes.

Participants will: Be selected based on criteria including age (18-35 years), non-elite athletic status (minimum two months), exercising 2-5 days per week for approximately 3.2 hours on average Have a Body Mass Index (BMI) between 18.5-25 kg/m² Participate voluntarily Exclusion criteria include:Any disease affecting the inner or outer ear BMI below 18.5 kg/m² or above 25 kg/m²

详细描述

The vagus nerve (VN), the tenth cranial nerve, is a key component of the neuroendocrine-immune axis and plays a critical role in regulating autonomic functions such as cardiovascular, endocrine, respiratory, and digestive system activity through its extensive central and peripheral connections (1,2). Non-invasive vagus nerve stimulation (VNS), particularly through auricular stimulation, has been shown to modulate autonomic balance by reducing sympathetic activity, enhancing cardiac baroreflex sensitivity, and improving parasympathetic tone (3,4).

In the context of athletic performance, the autonomic nervous system's role in adaptation to training and recovery is well recognized (5). Post-exercise parasympathetic reactivation is increasingly used as a biomarker for recovery and performance enhancement. Auricular VNS (aVNS), by stimulating afferent auricular branches of the VN, may facilitate recovery by reducing exercise-induced fatigue, pain, and lactate accumulation, while improving parasympathetic activity (3). Importantly, these physiological effects have been observed without significant alterations in heart rate or blood pressure.

Balance training is a known contributor to improved functional performance in athletes, and neuromuscular control is essential for injury prevention and overall athletic capacity (6). Considering the limited research on the effects of aVNS on neuromuscular parameters such as muscle strength and balance response in non-elite athletic populations, this study aims to provide evidence on the efficacy of aVNS in this context.

This study is designed as a non-randomized controlled trial. Thirty non-elite athletes aged 18-35 years, who have been physically active for at least three months and currently exercise 2-5 days per week (averaging 3.2 hours per week), will be recruited. Eligible participants must have a BMI between 18.5 and 25 kg/m² and provide informed consent. Individuals with conditions affecting the inner or outer ear or BMI values outside the specified range will be excluded.

The intervention group will receive a single session of bilateral aVNS using a biphasic, asymmetric waveform at a frequency of 25 Hz, pulse width of 300 microseconds, applied continuously for 20 minutes. The post-intervention follow-up period will last 30 minutes (3).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • •body mass index (BMI) between 18.5-25 kg/m²
  • •exercising for a total of 3 hours or more per week for at least three months

排除标准

  • •have a chronic musculoskeletal disease

研究组 & 干预措施

Vagus nerve stimulation

Experimental

Auricular vagus nerve stimulation (AVNS) will be applied to both ears simultaneously, using a biphasic, asymmetric waveform with pulses of 300 microsecond duration and a frequency of 25 Hz, continuously for 20 minutes. The application will be performed in a single session and the follow-up time will be determined as 30 minutes.

干预措施: Auricular vagus nerve stimulation (AVNS) (Device)

结局指标

主要结局

Muscle strenght

时间窗: Baseline and after the vagus stimulation apply

Muscle strength of quadriceps femoris and hamstring muscles will be evaluated by hand dynamometer.

Balance

时间窗: Baseline and after the vagus stimulation apply

Postural sway will be assessed by biodex balance with center of gravity characteristics anterior-posterior and lateral sway with eyes closed and open.

次要结局

未报告次要终点

研究者

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

Tuğçe Poyraz İşleyen

PT

Bahçeşehir University

研究点 (1)

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