Influence of Diaphragmatic Breathing Through Slow, Deep Respiration on Vagal Nerve Modulation and Stimulation of the Autonomic Nervous System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Heart rate variability (HRV)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental Group 1. SDB 6x 6
Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E) ratio of 1:1
干预措施: Guided breathing at 6 bpm with apnea (A) (Procedure)
Experimental Group 2. SDB 6x6x6
Guided breathing at 6 bpm with apnea (A) and an I:E:A ratio of 1:1:1.
干预措施: Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E) (Procedure)
Control Group
Breathing education
干预措施: Breathing education (Procedure)
结局指标
主要结局
Heart rate variability (HRV)
时间窗: Baseline
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor.
Heart rate variability (HRV)
时间窗: Immediately after treatment
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor
次要结局
- Characteristics demographics: Age(Baseline)
- Characteristics demographics: Gender(Baseline)
- Anthropometric variables: Weight(Baseline)
- Anthropometric variables: height(Baseline)
- RMSSD (root mean square of successive differences)(Baseline)
- SDRR (standard deviation of RR intervals)(Baseline)
- Pressure pain thresholds (PPTs)(Baseline)
- RMSSD (root mean square of successive differences)(Immediately after treatment)
- SDRR (standard deviation of RR intervals)(Immediately after treatment)
- Pressure pain thresholds (PPTs)(Immediately after treatment)
研究者
Ana Sedeño Vidal
Full Professor
University of Jaén
