Healthy Volunteers Clinical Trial
— ESautonomousOfficial title:
Effectiveness of Transcutaneous Electrical Stimulation on the Autonomous and Cardiovascular System on Healthy Young People; a Prospective, Randomized, Single-blind, Controlled Pilot Study
NCT number | NCT05289817 |
Other study ID # | 2020/011 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 22, 2022 |
Est. completion date | June 29, 2022 |
Verified date | October 2022 |
Source | Universidade da Coruña |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cardiovascular disease is one of the most important causes of death and disability in the world. An autonomic imbalance is associated to cardiovascular risks and disorders. Electrical stimulation (ES) applied by surface electrodes is a non-invasive therapeutic approach with low side-effects. In the last years, some studies had investigated the effects of ES on the autonomic nervous system and cardiovascular system. However, different intensities, frequencies and electrode locations had been used, which makes difficult to clarify the optimal parameters. The aim of this study is to analyze the effects of ES on autonomic nervous modulation in healthy subjects comparing three different locations of application for ES. Participants will be aleatory assigned to one of three groups for a single-session of 20-minute transcutaneous ES: a) an auricular intermittent ES in an area that is believed to be connected to the vagal nerve (cymba conchae); b) an auricular sham intermittent ES, meaning a real ES but applied on an ear location not connected to the vagal nerve (scapha); and c) an upper back continuous ES (C7-T4), a placement that is thought to be connected to the stellate (sympathetic) ganglion. All the protocols will be stated at a non-painful intensity. After that, the hand grip exercise will be executed. The heart rate variability (HRV) and heart frequency (HR) will be measured in four main times: the baseline, in the final minutes of the ES, after the ES and after finishing the hand grip exercise. Blood pressure will be measured also at all the time points except during the ES due to the possibility of interferences. Adverse effects will be assessed after ES and 48 h later. The study will provide initial knowledge about how different electrical stimulation locations contribute to reduce sympathetic excitation and improve the sympathovagal balance.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 29, 2022 |
Est. primary completion date | June 27, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - University students and academic or administrative staff, non smokers, self-perceived as healthy Exclusion Criteria: - No history of neurological, neurosurgical, psychiatric, cardiological disease, pulmonary disease, syncope, seizure, head trauma, cranial or neck surgery, aneurisms, or any condition or treatment which could affect the functioning of the autonomous nerve system or the cardiovascular system (by self-report). - BMI of 30 or over - High blood pressure (systolic blood pressure of 140 mmHg or over, or diastolic blood pressure of 90 mmHg or over) - Spontaneous respiratory rate under 10 breaths per minute - Professional athletes - Inability to reach the minimum amplitude required during electrical stimulation - Any arm or hand pain (dominant side) - Any contraindication for electrical stimulation (pregnancy or risk or being pregnant, any implanted electronical device, irritation or pain at the skin location for the electrodes, intolerance to electrical stimulation) or any condition which could affect the placement of the electrodes or the perception of the electrical stimulus. |
Country | Name | City | State |
---|---|---|---|
Spain | Universidade da Coruna | A Coruña |
Lead Sponsor | Collaborator |
---|---|
Universidade da Coruña |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blind outcome assessment | Subjects will be asked to tell if they think they were assigned to an active or a sham group | 15 minutes after the hand grip exercise | |
Other | Amplitude of electrical stimulation | mA are recorded every 5 minutes; mean mA is obtained by adding amplitude used in each 5 minutes period divided by 4, as 20 minutes is the total duration of the electrical stimulation | 20 minutes of electrical stimulation | |
Other | Respiratory frate | Number of breaths over the course of one minute. It will be visually monitored each 5 minutes, except during the grip exercise | 5 minutes before Electrical Stimulation, during 20 minutes of Electrical Stimulation, 5 minutes after Electrical Stimulation, 15 minutes after hand grip exercise | |
Other | Body Mass Index | Body Mass Index (kg/m^2) | Baseline | |
Other | Somatotype | Height (cm); Weight (Kg); Skinfolds (mm); Biepicondylar breadth of the humerus and femur (cm); Upper arm, elbow flexed and tensed, calf girth (cm).
Sheldon's somatotype classification is computed using the following equations: Endomorphy = -0,7182 + 0,1451X - 0,00068X^2 + 0,0000014X^3 where: X= sum of skinfolds (triceps + subscapular + supraspinale)*170.18 / Height Mesomorphy= (0.858*Biepicondylar breadth of the humerus + 0,601*Biepycondilar breadth of the femur + 0.188*Corrected Arm girth + 0.161*Corrected Calf girth) - (Height*0.131) + 4.5. Ectomorphy = Height - Weight ratio (HWR) according to the following conditions: If HWR=40.75, then: Ectomorphy = HWR×0.732-28.58 If HWR<40.75 but >38.25, then: Ectomorphy = HWR×0.463-17.63 If HWR=38.25, then: then: Ectomorphy = 0.1 |
Baseline | |
Other | Waist and hip circumferences | Cm of waist circumference and hip circumference. The waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference. | Baseline | |
Other | Waist to hip ratio | It will be calculated by dividing waist circumference by hip circumference | Baseline | |
Other | Body composition (bio impedance) | percentage of fat, muscle, water and bone (bio impedance) | Baseline | |
Other | Body density (BD) | BD=1.0988-0.0004*(skinfolds in mm of triceps + subscapular +biceps+ supraspinale +abdominal+ front thigh +medial calf) | Baseline | |
Other | Percent body fat (percentage BF) from body density (BD) | Percentage BF from BD = (4.570/BD-4.142) *100. | Baseline | |
Other | Fat mass | Fat mass (Kg) = body weight (kg) * percentage body fat/100 | Baseline | |
Other | Fat-free mass | Fat-free mass (Kg) = body weight (kg)-fat mass (kg) | Baseline | |
Other | Fat mass index (FMI) | FMI is calculated by dividing the fat mass by the stature-squared: fat mass/height^2 | Baseline | |
Other | Fat-free mass index (FFMI) | FFMI is calculated by dividing the fat-free mass by the stature-squared: fat-free mass/height^2 | Baseline | |
Other | Short International Physical Activity questionnaire (IPAQ) | IPAQ assesses physical activity as walking, moderate-intensity activities and vigorous intensity activities; frequency (days per week) and duration (time per day) are collected separately for each specific type of activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of each type of activity. Another measure is computed by weighting each type of activity by its energy requirements defined in METS (multiples of the resting metabolic rate) to yield a score in MET-minutes. These following values are used for the analysis of IPAQ data: Walking = 3.3 METs, Moderate PA = 4.0 METs and Vigorous PA = 8.0 METs. The higher the MET-minutes the more intense the physical activity is, with 0 indicating no activity at all. As there are no established thresholds for presenting MET-minutes, the IPAQ Research Committee proposes that these data are reported as comparisons of median values and interquartile ranges for different populations. | Baseline | |
Primary | RR | The time of RR intervals (ms) will be obtained from Polar S800 with Polar T31 transmitter (Polar Electro, Kempele, Finland), and it will be extracted with Kubios software (University of Eastern Finland, Kuopio, Finland). The mean values of RR intervals (ms) and the standard deviation of all RR intervals (ms) will be obtained. | 5 minutes before Electrical Stimulation, During 20 minutes Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | RMSSD | Root mean square of successive RR interval differences (ms). It will be obtained from Polar S800 with Polar T31 transmitter (Polar Electro, Kempele, Finland), and it will be extracted with Kubios software (University of Eastern Finland, Kuopio, Finland). | 5 minutes before Electrical Stimulation, During 20 minutes Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | pNN50 | Relative number of successive RR interval pairs that differ more than 50 ms (percentage). It will be obtained from Polar S800 with Polar T31 transmitter (Polar Electro, Kempele, Finland), and it will be extracted with Kubios software (University of Eastern Finland, Kuopio, Finland). | 5 minutes before Electrical Stimulation, During 20 minutes Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | HF | High frequency refers to HRV frequency band (0.15-0.4 Hz). It will be obtained from Polar S800 with Polar T31 transmitter (Polar Electro, Kempele, Finland), and it will be extracted with Kubios software (University of Eastern Finland, Kuopio, Finland). | 5 minutes before Electrical Stimulation, During 20 minutes Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | LF | Low frequency refers to HRV frequency band (0.04-0.15 Hz). It will be obtained from Polar S800 with Polar T31 transmitter (Polar Electro, Kempele, Finland), and it will be extracted with Kubios software (University of Eastern Finland, Kuopio, Finland). | 5 minutes before Electrical Stimulation, During 20 minutes Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | LF/HF | The ratio of LF to HF power will be calculated along with normalised LF/HF where baseline values will set to 1. It will be obtained from Polar S800 with Polar T31 transmitter (Polar Electro, Kempele, Finland), and it will be extracted with Kubios software (University of Eastern Finland, Kuopio, Finland). | 5 minutes before Electrical Stimulation, During 20 minutes Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | SD1 | The poincaré plot short term variability (ms). It will be obtained from Polar S800 with Polar T31 transmitter (Polar Electro, Kempele, Finland), and it will be extracted with Kubios software (University of Eastern Finland, Kuopio, Finland). | 5 minutes before Electrical Stimulation, During 20 minutes Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | SD2 | The poincaré plot long term variability (ms). It will be obtained from Polar S800 with Polar T31 transmitter (Polar Electro, Kempele, Finland), and it will be extracted with Kubios software (University of Eastern Finland, Kuopio, Finland). | 5 minutes before Electrical Stimulation, During 20 minutes Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | SD2/SD1 | Poincaré plot long and short term variability ratio. It will be obtained from Polar S800 with Polar T31 transmitter (Polar Electro, Kempele, Finland), and it will be extracted with Kubios software (University of Eastern Finland, Kuopio, Finland). | 5 minutes before Electrical Stimulation, During 20 minutes Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | Mean heart rate | The mean frequency will be obtained from Polar S800 with Polar T31 transmitter (Polar Electro, Kempele, Finland), and it will be extracted with Kubios software (University of Eastern Finland, Kuopio, Finland). | 5 minutes before Electrical Stimulation, during 20 minutes of Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | Systolic blood pressure | Blood pressure will be continuously acquired by SOMNOtouch NIBP (Somnomedics, GmbH, Randersacker, Germany) that is an ambulatory cuffless device for continuous (beat-to-beat), noninvasive BP monitoring. The system consists of a finger photoplethysmograph and three ECG leads, connected to a watch-like control unit placed at the wrist level and equipped with a screen where beat-to-beat pulse waveform, ECG, and PTT changes are displayed. All these measurements are unified to obtain systolic blood pressure in mmHg. | 5 minutes before Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | Diastolic blood pressure | Blood pressure will be continuously acquired by SOMNOtouch NIBP (Somnomedics, GmbH, Randersacker, Germany) that is an ambulatory cuffless device for continuous (beat-to-beat), noninvasive BP monitoring. The system consists of a finger photoplethysmograph and three ECG leads, connected to a watch-like control unit placed at the wrist level and equipped with a screen where beat-to-beat pulse waveform, ECG, and PTT changes are displayed. All these measurements are unified to obtain the diastolic blood pressure in mmHg. | 5 minutes before Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Primary | Mean arterial pressure | Blood pressure will be continuously acquired by SOMNOtouch NIBP (Somnomedics, GmbH, Randersacker, Germany) that is an ambulatory cuffless device for continuous (beat-to-beat), noninvasive BP monitoring. The system consists of a finger photoplethysmograph and three ECG leads, connected to a watch-like control unit placed at the wrist level and equipped with a screen where beat-to-beat pulse waveform, ECG, and PTT changes are displayed. All these measurements are unified to obtain the mean arterial pressure in mmHg. | 5 minutes before Electrical Stimulation, 5 minutes after Electrical Stimulation, During 3 minutes hand-grip exercise, 15 minutes after hand grip exercise | |
Secondary | Electrical simulation tolerance | The participants will be asked to rate their feelings during electrical stimulation by placing a solid vertical line on a 100-mm scale anchored by opposing descriptors (0=no sensation at all; 100 = pain onset or discomfort). Visual Analogue Scale (VAS) will be "scored" by measuring the rating with a ruler (millimeters) | 20 minutes after initiating electrical stimulation | |
Secondary | Rating of perceived effort | Subjective feelings of effort and fatigue of the arm using de Borg CR-10, from 0 (nothing at all) to 10 (almost maximal) | Immediately after the hand grip exercise | |
Secondary | Adverse effects | All posible adverse effects due to the electrical stimulation and the electrodes will be checked by a questionnaire | At 20 minutes after initiating electrical stimulation and at 48 hours after the electrical stimulation |
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