Neuromodulation of the Autonomic Nervous System in Athletes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-35
SponsorBakulev Scientific Center of Cardiovascular Surgery
About this trial
There are few studies in the literature that have evaluated the effects of using percutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery after physical exertion). It has been demonstrated that tVNS in athletes improved the rate of heart rate recovery, reduced lactic acid levels in blood plasma, reduced pain, reduced overtraining syndrome and fatigue levels.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Professional athletes over the age of 15 and under the age of 35;
Cyclic sports (swimming, modern pentathlon, athletics, triathlon);
Difficult coordination sports (dance sports, rhythmic gymnastics);
Sports category: no lower than candidate for master of sports;
Disqualifiers
Atypical and unrelated to physical exertion changes on the ECG (T wave inversion, st-segment depression, pathological Q waves, signs of left atrial enlargement, signs of right ventricular hypertrophy, ventricular pre-excitation, complete right or left bundle branch block, prolonged or shortened Q-T interval, Brugada-like early repolarization);
Heart rhythm and conduction disorders (frequent ventricular and supraventricular extrasystoles, first-degree atrioventricular block (P-Q > 0.21 s, not shortened during hyperventilation or physical exertion), second or third degree);
Expressed sinus bradycardia with resting heart rate < 40 bpm;
Taking glucocorticosteroids in the last 1 month;
Trial design
Design model
Parallel
Treatments tested in this trial
tVNS
DevicetVNS will be performed daily after workouts for 60 minutes over a period of 8 weeks.
Treatment groups
125 Participants
are divided into 2 treatment groupsGroup A: Active tVNSActive comparator 1 intervention
Group B: Sham tVNSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dynamics of maximum oxygen consumption (VO2max).
During a cardiorespiratory exercise test, the level of VO2max (ml/min/kg) is assessed.
Time frame
The level of VO2max is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and fictitious stimulation groups.2
The dynamics of the treadmill speed at the level of the anaerobic threshold of metabolism.
During the cardiorespiratory exercise test, the treadmill speed (km/h) is estimated at the level of the anaerobic metabolic threshold.
Time frame
Treadmill speed is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.Secondary outcomes
1
Dynamics of the treadmill speed at the level of the aerobic metabolism threshold of metabolism.
During the cardiorespiratory exercise test, the treadmill speed (km/h) is estimated at the level of the aerobic metabolic threshold.
Time frame
Treadmill speed is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.2
The dynamics of the heart rate (HR) at the level of the anaerobic threshold of metabolism.
During the cardiorespiratory exercise test, the HR is estimated at the level of the anaerobic metabolic threshold.
Time frame
HR is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.3
The dynamics of the heart rate (HR) at the level of the aerobic threshold of metabolism.
During the cardiorespiratory exercise test, the HR is estimated at the level of the aerobic metabolic threshold.
Time frame
HR is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.4
The dynamics of RMSSD.
During the time analysis of heart rate variability, the RMSSD parameter is estimated.
Time frame
This parameter is evaluated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the groups of active and fictitious stimulation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bakulev Scientific Center of Cardiovascular Surgery
Lead sponsor
Foundation for the Support of Physical Culture and Sports BECOME A CHAMPION
Collaborator
Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION
Collaborator
Source ClinicalTrials.gov