An interventional study of Osteopathic manipulative treatment and Yoga respiratory training in Pulmonary Arterial Hypertension, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 48 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.
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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.
Other: Osteopathic manipulative treatment · Other: Yoga respiratory training
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.
Other: Osteopathic manipulative treatment
Control group also consisted of 16 PAH patients and serves as the controls. No interventions were applied for the patients in this group. Similar with the patients in other two groups, pharmacological treatment of the patients in this group continued and they were advised for using their medication properly, Patients in this group were also 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.
The investigators applied six different OMT techniques including rib raising, diaphragm release, suboccipital decompression, first rib mobilization, mediastinum mobilization and thoracic inlet myofascial release. Rib raising is used to increase the mobility of the rib cage and to reduce vasoconstriction by regulating sympathetic tone. Diaphragm release is used to increase diaphragm movement. Suboccipital decompression involves traction of the base of the skull. We aim to improve respiration with mobilization of the first rib which is associated with sternum, sympathetic truncus and important vascular structures. Thoracic inlet is an important structure resisting intrathoracic pressure changes during respiration. Finally, the goal of the mediastinum mobilization is to increase the mobility of the rib cage by providing relaxation in the tension of the facial tissues.
Nadishodhana pranayama (Alternate nostril breathing), Ujjayi pranayama (Psychic breath) and Bhramari pranayama (Humming bee breath) were used for the study. Nadishodhana is one of the most common yoga breathing exercises and involves breathing through one nostril while closing the other one. The patients performed 2 sets of 8 breathing cycles with a resting time of 2 minutes between the sets. Ujjayi Pranayama involves soft contraction of laryngeal muscles and the partial closure of the glottis. The patients performed 2 sets of 10 breathing cycles per session with an inspiration:expiration phase as 1:2. Bhramari Pranayama includes a nasal humming sound during exhalation to create slight vibrations on the laryngeal walls, and the inner walls of the nostrils. The patients applied 2 sets of 10 breathing cycles per session with a respiration rate of 3-4/min.
Change from Baseline Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) at 8 weeks
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.
Time frame: Baseline and week 8
Change from Baseline Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) at 8 weeks
FEV1/FVC ratio (%) was recorded with regards to the highest FEV1 and FVC values measured by spirometry.
Time frame: Baseline and week 8
Change from Baseline Forced Expiratory Flow at 25-75% of FVC (FEF25-75) at 8 weeks
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.
Time frame: Baseline and week 8
Change from Baseline Peak Expiratory Flow (PEF) at 8 weeks
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.
Time frame: Baseline and week 8
Change from Baseline FVC%, FEV1%, FEF25-75%, PEF% at 8 weeks
FVC%, FEV1%, FEF25-75% and PEF% were recorded as the percentage of predicted values.
Time frame: Baseline and week 8
Change from Baseline Nitric Oxide Level at 8 weeks
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.
Time frame: Baseline and week 8
Change from Baseline Exercise Capacity at 8 weeks
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.
Time frame: Baseline and week 8
Change from Baseline 6MWD% at 8 weeks
6MWD% was recorded as the percentage of predicted distances. Higher scores indicate a better outcome.
Time frame: Baseline and week 8
Change from Baseline Changes of Perceived Dyspnea and Fatigue at 8 weeks
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.
Time frame: Baseline and week 8
Change from Baseline Resting Peripheral Oxygen Saturation (SpO2) at 8 weeks
SpO2 was measured by using a pulse oximeter and was recorded as percentage.
Time frame: Baseline and week 8
Change from Baseline Change of Blood Pressure at 8 weeks
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.
Time frame: Baseline and week 8
Change from Baseline Resting Heart Rate at 8 weeks
Resting heart rate was measured with a pulse oximeter and was recorded as beats per minute (bpm).
Time frame: Baseline and week 8
Change from Baseline Respiratory Muscle Strength at 8 weeks
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.
Time frame: Baseline and week 8
Change from Baseline Peripheral Muscle Strength at 8 weeks
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.
Time frame: Baseline and week 8
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Pulmonary Arterial Hypertension→
Istanbul University - Cerrahpasa