Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Other: Osteopathic manipulative treatmentOther: Yoga respiratory training
- Registration Number
- NCT04076241
- Lead Sponsor
- Istanbul University - Cerrahpasa (IUC)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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
- Tumors
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined intervention Osteopathic manipulative treatment Combined intervention group consisted of 16 pulmonary arterial hypertension (PAH) patients. Three different yoga breathing exercises were applied after osteopathic manipulative treatment (OMT). This combined intervention was applied 2 times a week for a period of 8 weeks with a total of 16 training sessions. There remained a 3-workday gap between two sessions. Patients in this group were thought about pathophysiology of PAH, benefits of physical activity, airway clearance, oxygen therapy, and importance of proper nutrition, adequate sleep, effective breathing after baseline assessment. Osteopathic manipulative treatment Osteopathic manipulative treatment OMT group consisted of 16 PAH patients. Six different OMT techniques were applied 2 times a week for a period of 8 weeks with a total of 16 sessions. The same osteopathic manipulative treatment techniques applied to combined intervention group were used for this study group. There remained a 3-workday gap between two sessions. Patients in this group were thought about pathophysiology of PAH, benefits of physical activity, airway clearance, oxygen therapy, and importance of proper nutrition, adequate sleep, effective breathing after baseline assessment. Combined intervention Yoga respiratory training Combined intervention group consisted of 16 pulmonary arterial hypertension (PAH) patients. Three different yoga breathing exercises were applied after osteopathic manipulative treatment (OMT). This combined intervention was applied 2 times a week for a period of 8 weeks with a total of 16 training sessions. There remained a 3-workday gap between two sessions. Patients in this group were thought about pathophysiology of PAH, benefits of physical activity, airway clearance, oxygen therapy, and importance of proper nutrition, adequate sleep, effective breathing after baseline assessment.
- Primary Outcome Measures
Name Time Method Change from Baseline Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) at 8 weeks 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 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 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 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 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 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 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 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 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 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 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 Baseline and week 8 Resting heart rate was measured with a pulse oximeter and was recorded as beats per minute (bpm).
- Secondary Outcome Measures
Name Time Method Change from Baseline Respiratory Muscle Strength at 8 weeks Baseline and week 8 MIP and MEP were recorded as cmH2O, as well as MIP% and MEP% were recorded as the percentage of predicted values according to age and gender, as described by Black and Hyatt.
Change from Baseline Peripheral Muscle Strength at 8 weeks Baseline and week 8 Hand grip strength was measured with a hand-held dynamometer bilaterally. Three measurements on both hands were performed and the highest values were recorded in kilograms.
Trial Locations
- Locations (1)
Istanbul University-Cerrahpasa, Cardiology Institute
🇹🇷Istanbul, Turkey