The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Sports Physical Therapy Activity, Motor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Unilateral Stimulation

After evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load.

It will be re-evaluated after the cycling exercise application. After the assessment is complete, stimulation will be given with Vagustim non-invasively for 30 minutes. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.

With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.

Group Type EXPERIMENTAL

Unilateral Stimulation

Intervention Type DEVICE

With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.

Bicycle Ergometer Test

Intervention Type DIAGNOSTIC_TEST

Participants in this group were asked to perform bicycle exercise with maximum performance under 30 watts for 30 minutes.

Lactat Scout

Intervention Type DIAGNOSTIC_TEST

For lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L.

Polar H10

Intervention Type DIAGNOSTIC_TEST

RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained.

Vagustim Device

Intervention Type DEVICE

Vagustim Health Technologies Vagus stimulator device is used for this experiment.

Bilateral Stimulation

After evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load.

It will be re-evaluated after the cycling exercise application. After the assessment is complete, stimulation will be given with Vagustim non-invasively for 20minutes. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.

With the Vagustim device, vagus nerve stimulation will be applied in bilateral ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.

Group Type EXPERIMENTAL

Bilateral Stimulation

Intervention Type DEVICE

With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.

Bicycle Ergometer Test

Intervention Type DIAGNOSTIC_TEST

Participants in this group were asked to perform bicycle exercise with maximum performance under 30 watts for 30 minutes.

Lactat Scout

Intervention Type DIAGNOSTIC_TEST

For lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L.

Polar H10

Intervention Type DIAGNOSTIC_TEST

RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained.

Vagustim Device

Intervention Type DEVICE

Vagustim Health Technologies Vagus stimulator device is used for this experiment.

Bilateral Sham Stimulation

After evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load. Bisiklet egzersiz uygulaması sonrasında tekrar değerlendirilecektir.

It will be re-evaluated after the cycling exercise. After the assessment is complete, sham stimulation with Vagustim for 20 minutes will be given non-invasively. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.

Group Type SHAM_COMPARATOR

Bilateral Sham Stimulation

Intervention Type DEVICE

Participants were shown that the device was working, but no current was given.

Bicycle Ergometer Test

Intervention Type DIAGNOSTIC_TEST

Participants in this group were asked to perform bicycle exercise with maximum performance under 30 watts for 30 minutes.

Lactat Scout

Intervention Type DIAGNOSTIC_TEST

For lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L.

Polar H10

Intervention Type DIAGNOSTIC_TEST

RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained.

Vagustim Device

Intervention Type DEVICE

Vagustim Health Technologies Vagus stimulator device is used for this experiment.

Interventions

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Unilateral Stimulation

With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.

Intervention Type DEVICE

Bilateral Stimulation

With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.

Intervention Type DEVICE

Bilateral Sham Stimulation

Participants were shown that the device was working, but no current was given.

Intervention Type DEVICE

Bicycle Ergometer Test

Participants in this group were asked to perform bicycle exercise with maximum performance under 30 watts for 30 minutes.

Intervention Type DIAGNOSTIC_TEST

Lactat Scout

For lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L.

Intervention Type DIAGNOSTIC_TEST

Polar H10

RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained.

Intervention Type DIAGNOSTIC_TEST

Vagustim Device

Vagustim Health Technologies Vagus stimulator device is used for this experiment.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes