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

NCT04076241 | Completed DMC

• 1 other identifier: 2018/0180
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial hypertension; Yoga respiratory training; Osteopathic manipulative treatment; Exhaled nitric oxide; Cardiopulmonary function

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  Baseline and week 8

Secondary Outcomes (2)

• 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

Study Arms (3)

Combined intervention

EXPERIMENTAL

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

Osteopathic manipulative treatment

ACTIVE COMPARATOR

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

NO INTERVENTION

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.

Interventions

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.

Combined intervention; Osteopathic manipulative treatment

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.

Combined intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Cardiology Institute

Istanbul, Turkey (Türkiye)

Location

Related Publications (19)

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  RESULT

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  RESULT

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Baha Naci, PhD.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Rengin Demir, PhD.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Mehmet Serdar Kucukoglu, MD

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 3, 2019
• Study Start: September 7, 2019
• Primary Completion: April 2, 2020
• Study Completion: April 2, 2020
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

TU (1)