The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery

NCT05778058 | Completed DMC

• 1 other identifier: VNS003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Sports Physical Therapy; Activity, Motor

Keywords

Vagus Nerve Stimulation; Physiological Parameters; Recovery; Cycle Ergometer Test; Transcutaneous Auricular

Outcome Measures

Primary Outcomes (6)

• Evaluation of autonomous parameters

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

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

• Numerical Fatigue Rating Scale

  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.

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

• Numerical Pain Rating Scale

  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.

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

• Bicycle Ergometer Test

  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.

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

• 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.

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

• 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.

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

Study Arms (3)

Unilateral Stimulation

EXPERIMENTAL

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.

Device: Unilateral Stimulation; Diagnostic Test: Bicycle Ergometer Test; Diagnostic Test: Lactat Scout; Diagnostic Test: Polar H10; Device: Vagustim Device

Bilateral Stimulation

EXPERIMENTAL

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.

Device: Bilateral Stimulation; Diagnostic Test: Bicycle Ergometer Test; Diagnostic Test: Lactat Scout; Diagnostic Test: Polar H10; Device: Vagustim Device

Bilateral Sham Stimulation

SHAM COMPARATOR

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.

Device: Bilateral Sham Stimulation; Diagnostic Test: Bicycle Ergometer Test; Diagnostic Test: Lactat Scout; Diagnostic Test: Polar H10; Device: Vagustim Device

Interventions

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.

Unilateral Stimulation

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 Stimulation

Bilateral Sham Stimulation DEVICE

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

Bilateral Sham Stimulation

Bicycle Ergometer Test DIAGNOSTIC_TEST

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

Bilateral Sham Stimulation; Bilateral Stimulation; Unilateral Stimulation

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.

Bilateral Sham Stimulation; Bilateral Stimulation; Unilateral Stimulation

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.

Bilateral Sham Stimulation; Bilateral Stimulation; Unilateral Stimulation

Vagustim Device DEVICE

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

Bilateral Sham Stimulation; Bilateral Stimulation; Unilateral Stimulation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinop University: lead

Study Sites (1)

Sefa Haktan Hatik

Sinop, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• SEFA HAKTAN HATIK, Asst. Prof

  Sinop University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: March 21, 2023
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

TU (1)