Healthy Volunteers
Conditions
Interventions
This is a three-arm crossover clinical trial, therefore the sample will be allocated to a single group of 30 individuals who will participate in three phases with three interventions: Full Spectrum oi
D02.455.849.090.810
Sponsors
Universidade Federal do Rio Grande do Norte
Hospital Universitário Onofre Lopes
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Both sexes; young people; between 18 and 50 years old; who declare themselves healthy; with body mass index (BMI) within normal limits; that do not present changes in respiratory function; do not present uncontrolled/treated psychological disorders; do not use regular medications; have not had exposure to Cannabis in the last 6 months
Exclusion criteria
Exclusion criteria: Dropouts; are unable to understand or carry out any of the study steps; present some clinical instability during the procedures (HR greater than 85% of their maximum HR; present before or during the assessment hypertensive peak with SBP> 180 and/or DBP>110 and/or hypertensive crisis with BP>190/90 mmHg or 175/115 mmHg); women who are pregnant at the time of collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular hemodynamic assessment, measuring heart rate, cardiac output index, left ventricular systolic work index and systemic vascular resistance index, using PhysioFlow®, which is a non-invasive cardiac output monitor that provides hemodynamic parameters in pre, in and post intervention measurements;It is expected to find the respiratory drive verified by measuring Airway Occlusion Pressure (P0.1). P0.1 is a measurement of the pressure generated spontaneously in the initial inspiratory effort, at the end of a forced expiration using a vacuum manometer device. The measurement is given in cm H2O, and will also be evaluated in % of predicted to check the respiratory drive in pre, in and post intervention measurements.;To evaluate the variation in the electrical activity of the respiratory muscles at rest and during the use of moderate inspiratory load, using the Electromyography evaluation method of the sternocleidomastoid, scalene, parasternal and rectus abdominis muscles, using sensors attached to the bellies of the muscles. The results are given on frequency and time scales that will be analyzed and transformed into percentages of the Root Mean Square (RMS), median frequencies, high pass and low pass powers. We will observe the behavior of respiratory muscle electrical activity under the effect of cannabis oils and placebo in pre, in and post intervention assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate respiratory mechanics through Optoelectronic Plethysmography (BTS Bioengineering) where tidal volume values ??of the chest wall and its compartments (liters) can be observed, as well as measurements of time (seconds), respiratory frequency (rpm) and percentage of participation of each compartment (%), in pre, in and post intervention measurements;To evaluate muscle oxygenation during inspiratory effort with load under the effect of the proposed interventions using the near-infrared spectroscopy (NIRS) technique coupled to the vastus medialis muscle in pre-, in- and post-intervention measurements, which presents measurements of absolute concentrations of oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb), total hemoglobin (tHb) and tissue saturation index in muscle tissue (TSI) in measurements before, during and after the intervention;It is expected to identify the presence and severity of anxiety symptoms in the participant using the Hamilton Anxiety Scale composed of 14 items, scored from 0 (not present) to 4 (severe), with a total score of 0 to 56, where the score <17 indicates a mild degree of anxiety, between 18 and 24 points indicates moderate severity and between 25 and 30 points indicates moderate to severe anxiety, before, during and after using the interventions;Assess fatigue and dyspnea perceived and reported by the participant will be evaluated using the Borg and Dyspnea Scale, a numerical scale from 0 to 10, where 0 indicates no fatigue or shortness of breath and 10 indicates the greatest fatigue or shortness of breath reported, measures in the rest, valve and recovery phases, in the moments before, during and after intervention | — |
Countries
Brazil
Contacts
Public ContactEdna;Marina Laurentino;Fagundes
Universidade Federal do Rio Grande do Norte;Universidade Federal do Rio Grande do Norte
Outcome results
None listed