The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery (TAVNSCER)

Sinop University

Status: Completed

Conditions: Healthy; Sports Physical Therapy; Activity, Motor

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05778058

VNS003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Unilateral Stimulation

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Lactat Scout

Device: Unilateral Stimulation

Diagnostic Test: Bicycle Ergometer Test

Diagnostic Test: Polar H10

Device: Vagustim Device

Bilateral Stimulation

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Lactat Scout

Diagnostic Test: Bicycle Ergometer Test

Diagnostic Test: Polar H10

Device: Bilateral Stimulation

Device: Vagustim Device

Bilateral Sham Stimulation

Sham Comparator group

Description:

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.

Treatment:

Diagnostic Test: Lactat Scout

Diagnostic Test: Bicycle Ergometer Test

Diagnostic Test: Polar H10

Device: Bilateral Sham Stimulation

Device: Vagustim Device