Clinical trial NCT06796101: The Effect of Auricular Vagus Nerve Stimulation and Controlled Breathing Exercises on Performance and Autonomic Nervous System
Official title: The Effect of Auricular Vagus Nerve Stimulation and Controlled Breathing Exercises on Performance and Autonomic Nervous System in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health People
Physical Activity
Autonomic Nerveus System
Vagus Nerve Stimulations
Keywords: Transcutaneous vagus nerve stimulation
Performance
Controlled breathing exercises
Autonomic nervous system
recreactional
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals who are moderately physically active according to the physical activity scale between the ages of 18-35 who met the inclusion criteria will be included in the study. The sample size of the study is calculated as 64 and randomized to vagus stimulation and controlled breathing exercise groups. All evaluations of the participants will be held at Bahçeşehir University Faculty of Health Sciences Biomechanics chiropractic laboratory.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Performance
timeFrame: Baseline and 2 weeks.
measure: Autonomic nervous system
timeFrame: Baseline and 2 weeks.
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: Baseline
measure: Modified Borg Scale
timeFrame: Baseline and 2 weeks.
measure: Perceived Stress Scale
timeFrame: Baseline and 2 weeks.
measure: Blood Pressure Measurement
timeFrame: Baseline and 2 weeks.
measure: Pulse
timeFrame: Baseline and 2 weeks.
measure: Oxygen Saturation
timeFrame: Baseline and 2 weeks.
Other outcomes:
Locations:
city: Turkey
country: Turkey
facility: Bahçesehir University
state: Istanbul
Study officials:
affiliation: Bahçeşehir University
name: Okan ŞAHİN, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Bahçeşehir University
name: Ali Veysel ÖZDEN, MD, PHD
role: STUDY_DIRECTOR
References: