About this trial
Introduction:
Slow, deep breathing has demonstrated beneficial effects on the autonomic nervous system, particularly by increasing parasympathetic activity through vagal nerve modulation. Previous studies suggest that this breathing pattern optimizes the sympathovagal balance, modifies physiological parameters such as heart rate, blood pressure, and oxygen saturation, and influences variables including heart rate variability (HRV) and RR intervals.
Objectives:
To analyze the effects of different slow deep breathing (SDB) training modalities on vagal tone regulation. Secondary objectives include evaluating their impact on heart rate and rhythm, HRV, cardiac beat intervals, blood pressure, and oxygen saturation.
Methodology:
A randomized, controlled, single-blind, parallel-design clinical trial will be conducted. Sixty healthy participants will be enrolled and allocated into three groups: two experimental groups (SDB with and without apnea) and one control group (breathing education). Pre- and post-intervention measurements will include HRV, RR intervals, heart rate, blood pressure, oxygen saturation, and cervical joint variables. Data will be analyzed using repeated-measures ANOVA and statistical tests appropriate for each variable type, with a significance level set at 5%.
Expected Results:
SDB-based interventions are expected to produce significant improvements in vagal regulation, increasing heart rate variability and favorably modifying the aforementioned physiological parameters compared with the control group.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy individuals who have not smoked during the 24 hours prior to the study.
Healthy individuals who have not drunk alcohol during the 24 hours prior to the study.
Healthy individuals who have not drunk coffee during the 24 hours prior to the study.
Disqualifiers
Individuals with cardiovascular diseases or neurological disorders.
Individuals with cognitive impairment.
Individuals taking medications that affect autonomic nervous system function, such as: benzodiazepines, beta-blockers or beta-adrenergic agents.
Trial design
Parallel
Treatments tested in this trial
Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E)
Procedure/SurgerySpontaneous breathing in adults typically ranges between 12 and 20 breaths per minute (bpm), whereas slow, deep breathing (SDB) is usually performed as guided breathing at approximately 4 to 6 bpm.
Guided breathing at 6 bpm with apnea (A)
Procedure/SurgerySpontaneous breathing in adults typically ranges between 12 and 20 breaths per minute (bpm), whereas slow, deep breathing (SDB) is usually performed as guided breathing at approximately 4 to 6 bpm.
Breathing education
Procedure/SurgeryBreathing education consists of teaching individuals to understand, control, and optimize their breathing patterns.
Treatment groups
Trial outcomes
Primary outcomes
Heart rate variability (HRV)
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor.
Heart rate variability (HRV)
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor
Secondary outcomes
Anthropometric variables: Weight
Weight was measured using a calibrated digital scale
RMSSD (root mean square of successive differences)
RMSSD (root mean square of successive differences) measured using the validated Elite HRV application
SDRR (standard deviation of RR intervals)
SDRR (standard deviation of RR intervals): assessed using the validated Elite HRV application.
Pressure pain thresholds (PPTs)
Pressure pain sensitivity was evaluated using a digital algometer (FPIX; Wagner Instruments, Greenwich, CT, EE.UU). PPTs were measured at the spinous process of C3-C4.
Sponsors and contacts
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