Healthy Clinical Trial
— TAVNSCEROfficial title:
he Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Cycling Ergometry and Recovery in Healthy Young Individuals
NCT number | NCT05778058 |
Other study ID # | VNS003 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2022 |
Est. completion date | August 1, 2022 |
Verified date | March 2023 |
Source | Sinop University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | August 1, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Sefa Haktan Hatik | Sinop |
Lead Sponsor | Collaborator |
---|---|
Sinop University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. |
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