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Completed

NCT Number: NCT05778058

The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery

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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Key information

Conditions

Healthy Activity, Motor Behavior Motor Activity Sports Physical Therapy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sefa Haktan Hatik

Sinop, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unilateral Stimulation

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.

Bilateral Stimulation

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.

Bilateral Sham Stimulation

Device

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

Bicycle Ergometer Test

Diagnostic Test

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

Lactat Scout

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

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

Device

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

Primary outcomes

  1. Evaluation of autonomous parameters

    Time frame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.

    Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.

  2. Numerical Fatigue Rating Scale

    Time frame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.

    The fatigue NRS is a patient-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing 'no fatigue' and 10 representing 'as bad as you can imagine'. Patients are asked to 'please rate your fatigue (weariness, tiredness) by selecting the number.

  3. Numerical Pain Rating Scale

    Time frame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.

    Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain.

  4. Bicycle Ergometer Test

    Time frame: It was measured 4 times in aggregation in the 4-day protocol.

    All participants will be asked to perform cycling exercise at maximum performance for 30 minutes under a load of 30 watts. Then, the distance (meters) covered during the exercise will be evaluated for the sportive performance of the participants.

  5. Lactat Scout

    Time frame: It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.

    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.

  6. Polar H10

    Time frame: It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.

    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.

Sponsors and collaborators

Lead sponsor

Sinop University

Other

Registry information

Official study title

he Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Cycling Ergometry and Recovery in Healthy Young Individuals

Acronym: TAVNSCER

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2023
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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