Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05778058
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2021-09-15
Brief Title:
The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery
Sponsor:
Sinop University
Organization:
Sinop University
Study Overview
Official Title:
he Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Cycling Ergometry and Recovery in Healthy Young Individuals
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAVNSCER
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 n30 Bilateral Stimulation n30 and Bilateral Sham Stimulation n30 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
The groups are It will be in the form of Unilateral Stimulation n30 Bilateral Stimulation n30 and Bilateral Sham Stimulation n30 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None