Effects of Biofeedback and Coherent Breathing on Autonomic and Cognitive Function in Hypertensive Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure (SBP, mmHg) measured immediately post-intervention compared to baseline.
研究概览
简要总结
This randomized controlled trial will evaluate the immediate effects of heart rate biofeedback and slow coherent breathing on blood pressure, autonomic function (heart rate variability), and cognitive function in adults with Stage I or II hypertension. Ninety participants will be randomized into three groups: HR biofeedback, coherent breathing, and control (quiet rest). Primary outcome is change in systolic blood pressure post-intervention; secondary outcomes include HRV, Stroop/SART task performance, and subjective stress and calmness. The study aims to clarify the role of non-pharmacological autonomic modulation strategies in hypertension management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with Stage I or Stage II hypertension (SBP 130–179 mmHg or DBP 80–119 mmHg).
- •Either untreated or on a stable antihypertensive regimen for more than 4 weeks.
- •Willing and able to provide informed consent and comply with study procedures.
排除标准
- •Secondary hypertension.
- •Diabetes mellitus (HbA1c less than 6.5%).
- •Major organ dysfunction (renal, hepatic, or cardiac failure).
- •History of stroke, epilepsy, dementia, schizophrenia, or bipolar disorder.
结局指标
主要结局
Change in Systolic Blood Pressure (SBP, mmHg) measured immediately post-intervention compared to baseline.
时间窗: Baseline and Post-intervention/control
次要结局
- Autonomic function: Heart Rate Variability indices (RMSSD, LF/HF ratio).(Baseline, during intervention and after intervention)
- Cognitive function: Stroop Task (interference score, accuracy); SART (commission and omission errors)(Baseline and Post-intervention/control)
- Psychological measures: Perceived Stress Scale (PSS-10), Visual Analogue Scales (calmness, attention)(Baseline and Post-intervention/control)
研究者
Dr Subodh Pandey
Gandhi Medical College, Bhopal