Healthy Adult Male and Female Volunteers
Conditions
Keywords
Slow diaphragmatic breathing, autonomic nervous system, heart rate variability
Brief summary
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.
Interventions
PROCEDUREGuided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E)
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.
PROCEDUREGuided breathing at 6 bpm with apnea (A)
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.
PROCEDUREBreathing education
Breathing education consists of teaching individuals to understand, control, and optimize their breathing patterns.
Sponsors
University of Jaén
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability (HRV) | Baseline | Heart rate variability (HRV): measured using the Polar H10 heart rate sensor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric variables: Weight | Baseline | Weight was measured using a calibrated digital scale |
| RMSSD (root mean square of successive differences) | Baseline | RMSSD (root mean square of successive differences) measured using the validated Elite HRV application |
| SDRR (standard deviation of RR intervals) | Baseline | SDRR (standard deviation of RR intervals): assessed using the validated Elite HRV application. |
| Pressure pain thresholds (PPTs) | 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. |
| Anthropometric variables: height | Baseline | Height was measured with a calibrated stadiometer |
| Characteristics demographics: Age | Baseline | Age was self-reported by the participants |
| Characteristics demographics: Gender | Baseline | Gender was self-reported by the participants |
Countries
Spain
Outcome results
None listed