Clinical trial NCT05778058: The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery
Official title: he Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Cycling Ergometry and Recovery in Healthy Young Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Sports Physical Therapy
Activity, Motor
Keywords: Vagus Nerve Stimulation
Physiological Parameters
Recovery
Cycle Ergometer Test
Transcutaneous Auricular
Lead sponsor: Sinop University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 90 healthy young individuals were included in the study. Participants were randomly divided into 3 groups as unilateral (n=30, 15 female, 15 male), bilateral (n=30, 15 female, 15 male) and bilateral sham (n=30, 15 female, 15 male) groups. ). The cycling exercise was performed at maximum performance for 30 minutes under the same wattage load. Non-invasive ear stimulation was performed with the Vagustim device according to the participant groups. Pulse, systolic and diastolic blood pressure, distance, pain, fatigue, lactic acid level and autonomic nervous system were evaluated before, after and at the end of cycling exercise. Oneway Anova test and Kruskal Wallis test were used between groups. Dunn's test was used to determine the group that caused the difference. Analysis of variance was used for repeated measurements, Bonferroni test and Friedman test were used for in-group comparisons. Significance was evaluated at the p\<0.05 level.
Primary purpose: BASIC_SCIENCE

Brief summary: It is aIt is aimed to examine the possible benefits and effects of the use of Transcutaneous Auricular Vagus Nerve Stimulation to be applied in healthy individuals for sportive purposes on recovery and sportive performance level.

Detailed description: The 90 people between the ages of 18-35 will be included in the study. Each participant will be randomly divided into 3 groups to be homogeneous after the necessary calculations are made by evaluating with age, gender, weight, height and body mass index before starting the study.

The groups are; It will be in the form of Unilateral Stimulation (n=30), Bilateral Stimulation (n=30) and Bilateral Sham Stimulation (n=30) groups.

After the initial assessment, participants in all groups will be asked to do 30 minutes of cycling exercise at maximum performance under the same wattage load. Cycling will be re-evaluated after exercise. After the assessment is complete, stimulation will be given with Vagustim for 20 minutes non-invasively. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.

After the pain and fatigue rating scale, the evaluation will be completed by determining the lactate level in the blood with the Lactat Scout. Vagus nerve stimulation will be applied with the Vagustim device for 20 minutes, keeping it biphasic, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current where the participant feels the current comfortably.

At the end of the Cycling Ergometer Test and Vagus nerve stimulation, the Autonomic Nervous System, pulse and blood pressure will be evaluated with Polar H10 within 5 minutes.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals between the ages of 18-35,
* Willingness to participate in the study
* Having signed the informed consent form

Exclusion Criteria:

* Cases do not want to continue the study.
* Having regular sports habits or starting in the working process,
* Having a disease related to the respiratory system and starting to use drugs
* Having a disease related to the cardiac system and starting to use drugs
* Presence of any chronic disease and using a drug related to it

Primary outcomes:
measure: Evaluation of autonomous parameters
timeFrame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
measure: Numerical Fatigue Rating Scale
timeFrame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
measure: Numerical Pain Rating Scale
timeFrame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
measure: Bicycle Ergometer Test
timeFrame: It was measured 4 times in aggregation in the 4-day protocol.
measure: Lactat Scout
timeFrame: It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.
measure: Polar H10
timeFrame: It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.
Secondary outcomes:
Other outcomes:
Locations:
city: Sinop
country: Turkey
facility: Sefa Haktan Hatik
Study officials:
affiliation: Sinop University
name: SEFA HAKTAN HATIK, Asst. Prof
role: STUDY_DIRECTOR
References: