Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment on Exhaled Nitric Oxide Level and Cardiopulmonary Function in Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change from Baseline Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) at 8 weeks
研究概览
简要总结
The investigators planned a randomized controlled study to investigate the effects of adding yoga respiratory training to osteopathic manipulative treatment (OMT), and OMT alone on exhaled nitric oxide level and cardiopulmonary function in patients with pulmonary arterial hypertension (PAH). Our hypothesis is that combined intervention including OMT and yoga respiratory training may improve exhaled nitric oxide level and cardiopulmonary function in patients with PAH.
详细描述
Pulmonary arterial hypertension (PAH) is characterized by a mean pulmonary arterial pressure of >20 mmHg, measured by right heart catheterization at rest. PAH begins in the small arteries of the pulmonary vasculature and is characterized by increased vasoconstriction. Pulmonary vasodilatation induced by perivascular nerve stimulation usually occurs with nitric oxide (NO). A decrease in the airway wall concentration of NO was detected in patients with PAH. It has been reported that patients with PAH have a mild to moderate decrease in lung volumes associated with disease severity. A decrease in exercise capacity and respiratory muscle strength has been reported in patients with PAH.
Osteopathic Manipulative Therapy (OMT) is a well-known manual therapy approved by World Health Organization. A single-session of OMT was found to increase pulmonary function, inspiratory muscle strength, oxygen saturation, and to reduce dyspnea and fatigue in individuals with severe chronic obstructive pulmonary disease. It has been observed that OMT increases parasympathetic activity and reduces blood pressure in patients with hypertension.
Pranayama breathing is an important component of of yoga. It has been reported that yoga respiratory training increases vagal tone and reduces sympathetic activity, increases vital capacity, controls heart rate and blood pressure, and improves respiratory muscle strength.
No study investigating the effects of adding yoga respiratory training to osteopathic manipulative treatment in patients with PAH was found in the literature. The investigators aimed to explore the effects of a combined intervention consisting of OMT and yoga breathing exercises, as well as OMT alone on exhaled NO level, pulmonary function, respiratory and peripheral muscle strength, and exercise capacity in patients with PAH.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary hypertension patients that are clinically and hemodynamically stable
- •Resting mean pulmonary arterial pressure > 20 millimeter of mercury (mmHg) during a right heart catheterization
- •Being over 18 years old
- •Volunteering to participate in the study and to sign a written informed consent form
- •Patients with New York Heart Association (NYHA) functional class I-II-III
- •Stable pulmonary hypertension patients that takes medication at least 3 months.
排除标准
- •Acute decompensated heart failure
- •Unstable angina pectoris
- •Recent thoracic or abdominal surgical procedures
- •Severe neurological impairments
- •Severe cognitive impairment
- •Recent syncope
- •Using the immune system drugs as a result of organ or tissue transplants
- •Fractures within the past six months
- •Osteoporosis
- •Pregnancy
结局指标
主要结局
Change from Baseline Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) at 8 weeks
时间窗: Baseline and week 8
FVC and FEV1 were recorded in liter (l) by using spirometry (Spiro USB, CareFusion US). Measurements were performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) recommendations.
Change from Baseline Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) at 8 weeks
时间窗: Baseline and week 8
FEV1/FVC ratio (%) was recorded with regards to the highest FEV1 and FVC values measured by spirometry.
Change from Baseline Forced Expiratory Flow at 25-75% of FVC (FEF25-75) at 8 weeks
时间窗: Baseline and week 8
FEF25-75 was recorded in liter/second (l/s) by using spirometry (Spiro USB, CareFusion US). Measurements were performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) recommendations.
Change from Baseline Peak Expiratory Flow (PEF) at 8 weeks
时间窗: Baseline and week 8
PEF was recorded in liter/minute (l/min) by using spirometry (Spiro USB, CareFusion US). Measurements were performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) recommendations.
Change from Baseline FVC%, FEV1%, FEF25-75%, PEF% at 8 weeks
时间窗: Baseline and week 8
FVC%, FEV1%, FEF25-75% and PEF% were recorded as the percentage of predicted values.
Change from Baseline Nitric Oxide Level at 8 weeks
时间窗: Baseline and week 8
Fractional Exhaled Nitric Oxide (FeNO) was measured according to ATS/ERS recommendations with a hand-held, portable device (NObreath, Bedfont, UK). After inhaling the ambient air for 2-3 seconds until the total lung capacity, the patient is asked to exhale into the device for more than 6 seconds at constant flow rate (50 milliliter/second) without holding breath. The mean of two technically acceptable values within 10% was recorded in parts per billion (ppb) and maximum six attempts were performed.
Change from Baseline Exercise Capacity at 8 weeks
时间窗: Baseline and week 8
Exercise capacity was measured with the 6 Minute Walk Test (6MWT) according to the ATS guidelines. The 6 minutes wallking distance (6MWD) was recorded in meters. Higher scores indicate a better outcome.
Change from Baseline 6MWD% at 8 weeks
时间窗: Baseline and week 8
6MWD% was recorded as the percentage of predicted distances. Higher scores indicate a better outcome.
Change from Baseline Changes of Perceived Dyspnea and Fatigue at 8 weeks
时间窗: Baseline and week 8
Perceived dyspnea and fatigue were measured before and immediately after 6MWT with modified Borg scale ranging from 0 to 10. Higher scores indicate a worse outcome. Changes of perceived dyspnea and fatigue were recorded.
Change from Baseline Resting Peripheral Oxygen Saturation (SpO2) at 8 weeks
时间窗: Baseline and week 8
SpO2 was measured by using a pulse oximeter and was recorded as percentage.
Change from Baseline Change of Blood Pressure at 8 weeks
时间窗: Baseline and week 8
Systolic and diastolic blood pressures were measured before and immediately after 6MWT with sphygmomanometer. Change of systolic blood pressure and change of diastolic blood pressure were recorded.
Change from Baseline Resting Heart Rate at 8 weeks
时间窗: Baseline and week 8
Resting heart rate was measured with a pulse oximeter and was recorded as beats per minute (bpm).
次要结局
- Change from Baseline Respiratory Muscle Strength at 8 weeks(Baseline and week 8)
- Change from Baseline Peripheral Muscle Strength at 8 weeks(Baseline and week 8)
研究者
Baha Naci
Principal Investigator
Istanbul University - Cerrahpasa (IUC)