Clinical trial NCT04076241: Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension
Yoga respiratory training
Osteopathic manipulative treatment
Exhaled nitric oxide
Cardiopulmonary function
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline Forced Expiratory Flow at 25-75% of FVC (FEF25-75) at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline Peak Expiratory Flow (PEF) at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline FVC%, FEV1%, FEF25-75%, PEF% at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline Nitric Oxide Level at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline Exercise Capacity at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline 6MWD% at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline Changes of Perceived Dyspnea and Fatigue at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline Resting Peripheral Oxygen Saturation (SpO2) at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline Change of Blood Pressure at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline Resting Heart Rate at 8 weeks
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Change from Baseline Respiratory Muscle Strength at 8 weeks
timeFrame: Baseline and week 8
measure: Change from Baseline Peripheral Muscle Strength at 8 weeks
timeFrame: Baseline and week 8
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa, Cardiology Institute
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Baha Naci, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Rengin Demir, PhD.
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Mehmet Serdar Kucukoglu, MD
role: STUDY_CHAIR
References:
citation: Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
citation: McLaughlin VV, Archer SL, Badesch DB, Barst RJ, Farber HW, Lindner JR, Mathier MA, McGoon MD, Park MH, Rosenson RS, Rubin LJ, Tapson VF, Varga J, Harrington RA, Anderson JL, Bates ER, Bridges CR, Eisenberg MJ, Ferrari VA, Grines CL, Hlatky MA, Jacobs AK, Kaul S, Lichtenberg RC, Lindner JR, Moliterno DJ, Mukherjee D, Pohost GM, Rosenson RS, Schofield RS, Shubrooks SJ, Stein JH, Tracy CM, Weitz HH, Wesley DJ; ACCF/AHA. ACCF/AHA 2009 expert consensus document on pulmonary hypertension: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association: developed in collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association. Circulation. 2009 Apr 28;119(16):2250-94. doi: 10.1161/CIRCULATIONAHA.109.192230. Epub 2009 Mar 30. No abstract available.
citation: Ayajiki K, Okamura T, Noda K, Toda N. Functional study on nitroxidergic nerve in isolated dog pulmonary arteries and veins. Jpn J Pharmacol. 2002 Jun;89(2):197-200. doi: 10.1254/jjp.89.197.
citation: World Health Organization (WHO) Benchmarks for training in traditional/complementary and alternative medicine: benchmarks for training in osteopathy. Geneva: WHO Press; 2010.
citation: Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
citation: American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
citation: Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.
citation: American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
citation: Girgis RE, Champion HC, Diette GB, Johns RA, Permutt S, Sylvester JT. Decreased exhaled nitric oxide in pulmonary arterial hypertension: response to bosentan therapy. Am J Respir Crit Care Med. 2005 Aug 1;172(3):352-7. doi: 10.1164/rccm.200412-1684OC. Epub 2005 May 5.
citation: Sun XG, Hansen JE, Oudiz RJ, Wasserman K. Pulmonary function in primary pulmonary hypertension. J Am Coll Cardiol. 2003 Mar 19;41(6):1028-35. doi: 10.1016/s0735-1097(02)02964-9.
citation: Desai SA, Channick RN. Exercise in patients with pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2008 Jan-Feb;28(1):12-6. doi: 10.1097/01.HCR.0000311502.57022.73.
citation: Kabitz HJ, Bremer HC, Schwoerer A, Sonntag F, Walterspacher S, Walker DJ, Ehlken N, Staehler G, Windisch W, Grunig E. The combination of exercise and respiratory training improves respiratory muscle function in pulmonary hypertension. Lung. 2014 Apr;192(2):321-8. doi: 10.1007/s00408-013-9542-9. Epub 2013 Dec 13.
citation: Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
citation: Yilmaz Yelvar GD, Cirak Y, Demir YP, Dalkilinc M, Bozkurt B. Immediate effect of manual therapy on respiratory functions and inspiratory muscle strength in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016 Jun 20;11:1353-7. doi: 10.2147/COPD.S107408. eCollection 2016.
citation: Curi ACC, Maior Alves AS, Silva JG. Cardiac autonomic response after cranial technique of the fourth ventricle (cv4) compression in systemic hypertensive subjects. J Bodyw Mov Ther. 2018 Jul;22(3):666-672. doi: 10.1016/j.jbmt.2017.11.013. Epub 2017 Dec 9.
citation: Nayar HS, Mathur RM, Kumar RS. Effects of yogic exercises on human physical efficiency. Indian J Med Res. 1975 Oct;63(10):1369-76. No abstract available.
citation: Singh S, Gaurav V, Parkash V. Effects of a 6-week nadi-shodhana pranayama training on cardio-pulmonary parameters. J. Phys. Educ. Sport Manag. 2: 44-47, 2011.
citation: Garg S, Chandla SS. Effect of nadi shodhan pranayama on pulmonary functions. Int J Health Sci Res. 6: 192-196, 2016.