Immediate autonomic and hemodynamic responses to ujjayi pranayama in adults with hypertension : A randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Heart rate variability
研究概览
简要总结
Hypertension is a major risk factor for cardiovascular morbidity and mortality and is associated with autonomic nervous system imbalance characterized by sympathetic overactivity and reduced parasympathetic tone. Yogic breathing techniques such as Ujjayi pranayama have been shown to influence autonomic regulation and cardiovascular function.
This study is a randomized parallel group active controlled trial designed to evaluate the immediate effects of Ujjayi pranayama on cardiovascular and autonomic parameters in individuals with primary hypertension. Ninety eligible participants will be randomly allocated to either an intervention group practicing Ujjayi pranayama or a control group undergoing quiet sitting with spontaneous breathing.
Cardiovascular and autonomic parameters including blood pressure, heart rate, mean arterial pressure, rate pressure product, and heart rate variability will be assessed during three time periods: five minutes before the intervention, five minutes during the intervention, and five minutes after the intervention.
The study aims to assess the immediate autonomic and cardiovascular responses to Ujjayi pranayama and to explore its potential role as a non pharmacological adjunct in the management of hypertension
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 30 to 65 years, of either sex.
- •Clinically diagnosed primary (essential) hypertension, defined as: Systolic Blood Pressure more than 140 mmHg and or Diastolic Blood Pressure more than 90 mmHg, measured on at least two occasions, or individuals receiving stable antihypertensive medication for at least 4 weeks.
- •Resting blood pressure at screening less than or equal to 180/110 mmHg. Individuals willing and able to participate in the study and comply with study procedures, including sitting quietly and performing guided breathing for 15 minutes.
- •Participants not practicing yoga, pranayama, meditation, or any structured breathing techniques regularly in the preceding 3 months.
- •Stable clinical condition without any acute illness at the time of enrollment.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •Secondary hypertension, including renal, endocrine, or drug-induced causes.
- •Severe or uncontrolled hypertension, defined as: Systolic BP more than 180 mmHg and or Diastolic more than BP 110 mmHg. History or evidence of major cardiovascular disease, including: Coronary artery disease or previous myocardial infarction Heart failure Significant valvular heart disease Clinically significant cardiac arrhythmias Diabetes mellitus with autonomic neuropathy or poorly controlled diabetes HbA1c more than 8.5 percent.
- •Known autonomic nervous system disorders or neurological conditions affecting autonomic regulation.
- •Chronic respiratory disorders that may interfere with breathing practices, such as: Bronchial asthma requiring regular medication Chronic obstructive pulmonary disease (COPD) Chronic kidney disease (Stage 3 or above), chronic liver disease, or any other severe systemic illness.
- •Current use of medications known to markedly affect autonomic function or HRV, including: Anti-arrhythmic drugs Tricyclic antidepressants or other centrally acting psychotropic drugs (Participants on antihypertensive drugs with stable dosage were not excluded.) Regular practice of yoga, pranayama, meditation, or breath-control techniques within the preceding 3 months.
- •Inability to perform Ujjayi Pranayama due to: Severe nasal obstruction Recent nasal or throat surgery Severe anxiety or panic disorder precipitated by breath regulation Consumption of caffeine, nicotine, or alcohol within 12 hours prior to assessment.
- •Pregnant or lactating women.
- •Presence of any acute illness, infection, or fever within the preceding 7 days.
- •Participation in another interventional clinical trial within the last 3 months.
结局指标
主要结局
Heart rate variability
时间窗: before the ujjayi pranayama 5 minutes | during ujjayi pranayama 5 minutes | after the ujjayi pranyama 5 minutes
Blood pressure
时间窗: before the ujjayi pranayama 5 minutes | during ujjayi pranayama 5 minutes | after the ujjayi pranyama 5 minutes
Heart rate
时间窗: before the ujjayi pranayama 5 minutes | during ujjayi pranayama 5 minutes | after the ujjayi pranyama 5 minutes
次要结局
- mean arterial pressure(rate pressure product)
研究者
Dr Govindan P
SDM College of Naturopathy and Yogic sciences, Ujire,