Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and week 8 |
| Change from Baseline Peripheral Muscle Strength at 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa, Cardiology Institute | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26320113 | Background | 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. | |
| 19332472 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |
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. |
| Baseline and week 8 |
| Background |
| 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. |
| 12120765 | Background | 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. |
| Background | World Health Organization (WHO) Benchmarks for training in traditional/complementary and alternative medicine: benchmarks for training in osteopathy. Geneva: WHO Press; 2010. |
| 16055882 | Background | 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. |
| 12186831 | Background | 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. |
| 5772056 | Background | 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. |
| 15817806 | Background | 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. |
| 12091180 | Background | 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. |
| 15879413 | Result | 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. |
| 12651053 | Result | 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. |
| 18277824 | Result | 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. |
| 24338088 | Result | 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. |
| 16982941 | Result | 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. |
| 27382271 | Result | 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. |
| 30100295 | Result | 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. |
| 1222951 | Result | 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. |
| Result | 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. |
| Result | Garg S, Chandla SS. Effect of nadi shodhan pranayama on pulmonary functions. Int J Health Sci Res. 6: 192-196, 2016. |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided