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

Istanbul University - Cerrahpasa (IUC)

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Other: Yoga respiratory training; Other: Osteopathic manipulative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04076241

2018/0180

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Combined intervention

Experimental group

Description:

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.

Treatment:

Other: Yoga respiratory training

Other: Osteopathic manipulative treatment

Osteopathic manipulative treatment

Active Comparator group

Description:

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.

Treatment:

Other: Osteopathic manipulative treatment

Control

No Intervention group

Description:

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.