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Completed

NCT Number: NCT04076241

Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa, Cardiology Institute

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Osteopathic manipulative treatment

Other

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.

Yoga respiratory training

Other

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.

Primary outcomes

  1. Change from Baseline Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) at 8 weeks

    Time frame: 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.

  2. Change from Baseline Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) at 8 weeks

    Time frame: Baseline and week 8

    FEV1/FVC ratio (%) was recorded with regards to the highest FEV1 and FVC values measured by spirometry.

  3. Change from Baseline Forced Expiratory Flow at 25-75% of FVC (FEF25-75) at 8 weeks

    Time frame: 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.

  4. Change from Baseline Peak Expiratory Flow (PEF) at 8 weeks

    Time frame: 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.

  5. Change from Baseline FVC%, FEV1%, FEF25-75%, PEF% at 8 weeks

    Time frame: Baseline and week 8

    FVC%, FEV1%, FEF25-75% and PEF% were recorded as the percentage of predicted values.

  6. Change from Baseline Nitric Oxide Level at 8 weeks

    Time frame: 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.

  7. Change from Baseline Exercise Capacity at 8 weeks

    Time frame: 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.

  8. Change from Baseline 6MWD% at 8 weeks

    Time frame: Baseline and week 8

    6MWD% was recorded as the percentage of predicted distances. Higher scores indicate a better outcome.

  9. Change from Baseline Changes of Perceived Dyspnea and Fatigue at 8 weeks

    Time frame: 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.

  10. Change from Baseline Resting Peripheral Oxygen Saturation (SpO2) at 8 weeks

    Time frame: Baseline and week 8

    SpO2 was measured by using a pulse oximeter and was recorded as percentage.

  11. Change from Baseline Change of Blood Pressure at 8 weeks

    Time frame: 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.

  12. Change from Baseline Resting Heart Rate at 8 weeks

    Time frame: Baseline and week 8

    Resting heart rate was measured with a pulse oximeter and was recorded as beats per minute (bpm).

Secondary outcomes

  1. Change from Baseline Respiratory Muscle Strength at 8 weeks

    Time frame: 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.

  2. Change from Baseline Peripheral Muscle Strength at 8 weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment on Exhaled Nitric Oxide Level and Cardiopulmonary Function in Patients With Pulmonary Arterial Hypertension

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 3, 2019
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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