University of Jaen
Jaén, 23071, Spain
NCT Number: NCT07445113
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Jaén, 23071, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Spontaneous 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.
Other names: Experimental Group 1. SDB 6x6
Spontaneous 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.
Other names: Experimental Group 2.SDB 6x6x6
Breathing education consists of teaching individuals to understand, control, and optimize their breathing patterns.
Other names: Control Group
Time frame: Baseline
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor.
Time frame: Immediately after treatment
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor
Time frame: Baseline
Weight was measured using a calibrated digital scale
Time frame: Baseline
RMSSD (root mean square of successive differences) measured using the validated Elite HRV application
Time frame: Baseline
SDRR (standard deviation of RR intervals): assessed using the validated Elite HRV application.
Time frame: Baseline
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.
Time frame: Immediately after treatment
RMSSD (root mean square of successive differences) measured using the validated Elite HRV application
Time frame: Immediately after treatment
SDRR (standard deviation of RR intervals) assessed using the validated Elite HRV application
Time frame: Immediately after treatment
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
Time frame: Baseline
Height was measured with a calibrated stadiometer
Time frame: Baseline
Age was self-reported by the participants
Time frame: Baseline
Gender was self-reported by the participants
Contact information is provided by the study sponsor or research team.
University of Jaén
Other
Influence of Diaphragmatic Breathing Through Slow, Deep Respiration on Vagal Nerve Modulation and Stimulation of the Autonomic Nervous System
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