Effects of Different Types of Physical Training in Patients With Pulmonary Arterial Hypertension.

Cardiovascular Diseases Clinical Trial

— PAH  

Official title:

Effects of Combined Training Versus Aerobic Training Versus Respiratory Muscle Training in Patients With Pulmonary Hypertension: A Randomized, Controlled Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03476629
• Other study ID #: PAH Rehabilitation
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2016
• Est. completion date: December 10, 2020

Study information

• Verified date: November 2020
• Source: University of Nove de Julho
• Contact: Luciana Malosá Sampaio, Professor
• Phone: +551133859241
• Email: lucianamalosa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although there has been some progress in pharmacological management of PAH, limited functional capacity and low survival still persist, but there is evidence that exercise training can be accomplished without adverse effects or damage to cardiac function and pulmonary hemodynamics. Specifically, improvements in symptoms, exercise capacity, peripheral muscle function and quality of life. Training programs need to be better studied and well defined, and their physiological effects during physical training and functional capacity. The aim of this study is to compare the effects of different training exercises on physical performance indicators.

Description:

Pulmonary arterial hypertension (PAH) is characterized by pathological changes in the pulmonary vasculature which cause an increase in pulmonary vascular resistance (PVR), restricting the flow of blood through the pulmonary circulation. It is a serious illness, progressive and usually fatal which causes significant functional limitation, mainly due to dyspnea. In order to maintain the flow of blood, pulmonary artery pressure (PAP) increases and the disease progresses leading to right ventricular dysfunction and right heart failure. Regardless of the cause of PAH, the pulmonary arteries and arterioles have reduced capacity, and increases in cardiac output during exercise is limited. As a result, the delivery of oxygen to peripheral muscles is impaired, contributing to the symptoms of fatigue and dyspnea. While the limitation of the cardiac output to meet peripheral oxygen demand during exercise largely reduces exercise capacity, musculoskeletal dysfunction may also be involved in the exercise limitation in patients with PAH. Changes such as, muscle atrophy, decreased oxidative enzymes and a greater number of type II muscle fibers lead to an early lactic acidosis and decreased functional capacity. A modest evidence exists that exercise training can be done without adverse effects or damage to cardiac and / or pulmonary hemodynamics however, the effectiveness PAH requires more research.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 10, 2020
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Having confirmed diagnosis of PAH, based on elevated pressure in the pulmonary artery measured by catheterization of the heart at rest, with WHO functional (World Health Organization's - Functional Assessment for Pulmonary Hypertension - modified after New York Heart Association Functional Classification (NYHA) functional classification) classes I, II, III or IV to capture PAH patients with pré-capillary involvement;
• Clinically stable with no previous hospitalizations in the last four weeks;
• Receiving PAH specific drug therapy for at least 3 months before the study began.

Exclusion Criteria:

• Use of continuous oxygen therapy;
• Significant musculoskeletal disease or pain / claudication members;
• Neurologic or cognitive impairment, psychiatric disorders or psychological mood (making it difficult for patients to understand the required tests);
• History of moderate or severe chronic lung disease;
• PAH patients with post-capillary involvement.
• Cardiac disease associated with cardiac failure, angina and / or unstable heart rhythm.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Familial Primary Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Other:
• Physical activity
Effects of different physical activity programs

Locations

Country	Name	City	State
Brazil	Santa Casa de São Paulo Hospital	São Paulo	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Nove de Julho	Faculdade de Ciências Médicas da Santa Casa de São Paulo, University of Miami

Country where clinical trial is conducted

Brazil, 

References & Publications (14)

Arena R, Lavie CJ, Milani RV, Myers J, Guazzi M. Cardiopulmonary exercise testing in patients with pulmonary arterial hypertension: an evidence-based review. J Heart Lung Transplant. 2010 Feb;29(2):159-73. doi: 10.1016/j.healun.2009.09.003. Epub 2009 Dec 6. — View Citation

Bauer R, Dehnert C, Schoene P, Filusch A, Bärtsch P, Borst MM, Katus HA, Meyer FJ. Skeletal muscle dysfunction in patients with idiopathic pulmonary arterial hypertension. Respir Med. 2007 Nov;101(11):2366-9. Epub 2007 Aug 6. — View Citation

de Man FS, Handoko ML, Groepenhoff H, van 't Hul AJ, Abbink J, Koppers RJ, Grotjohan HP, Twisk JW, Bogaard HJ, Boonstra A, Postmus PE, Westerhof N, van der Laarse WJ, Vonk-Noordegraaf A. Effects of exercise training in patients with idiopathic pulmonary arterial hypertension. Eur Respir J. 2009 Sep;34(3):669-75. doi: 10.1183/09031936.00027909. — View 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. Review. Erratum in: J Cardiopulm Rehabil Prev. 2008 Mar-Apr;28(2):table of contents. — View Citation

Gabbay E, Reed A, Williams TJ. Assessment and treatment of pulmonary arterial hypertension: an Australian perspective in 2006. Intern Med J. 2007 Jan;37(1):38-48. Review. — View Citation

Galiè 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. — View Citation

Kabitz HJ, Schwoerer A, Bremer HC, Sonntag F, Walterspacher S, Walker D, Schaefer V, Ehlken N, Staehler G, Halank M, Klose H, Ghofrani HA, Hoeper MM, Gruenig E, Windisch W. Impairment of respiratory muscle function in pulmonary hypertension. Clin Sci (Lond). 2008 Jan;114(2):165-71. — View Citation

Mainguy V, Maltais F, Saey D, Gagnon P, Martel S, Simon M, Provencher S. Effects of a rehabilitation program on skeletal muscle function in idiopathic pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2010 Sep-Oct;30(5):319-23. doi: 10.1097/HCR.0b013e3181d6f962. — View 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, Grünig 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. Epub 2006 Sep 18. — View Citation

Meyer FJ, Lossnitzer D, Kristen AV, Schoene AM, Kübler W, Katus HA, Borst MM. Respiratory muscle dysfunction in idiopathic pulmonary arterial hypertension. Eur Respir J. 2005 Jan;25(1):125-30. — View Citation

Naeije R. Breathing more with weaker respiratory muscles in pulmonary arterial hypertension. Eur Respir J. 2005 Jan;25(1):6-8. — View Citation

Rubin LJ. Primary pulmonary hypertension. N Engl J Med. 1997 Jan 9;336(2):111-7. Review. — View Citation

Schannwell CM, Steiner S, Strauer BE. Diagnostics in pulmonary hypertension. J Physiol Pharmacol. 2007 Nov;58 Suppl 5(Pt 2):591-602. Review. — View Citation

Velez-Roa S, Ciarka A, Najem B, Vachiery JL, Naeije R, van de Borne P. Increased sympathetic nerve activity in pulmonary artery hypertension. Circulation. 2004 Sep 7;110(10):1308-12. Epub 2004 Aug 30. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional exercise capacity	Oxygen consumption measurement during cardiopulmonary test	Change from Baseline to 15 weeks
Primary	6 Minute Walking Test	Distance in meters	Change from Baseline to 15 weeks
Primary	Incremental shuttle walking test	Distance in meters	Change from Baseline to 15 weeks
Secondary	Autonomic Nervous System	Assesment by Heat Rate Variability analysis	Change from Baseline to 15 weeks
Secondary	Respiratory Muscle Strength	Assesment by Test of Incremental Respiratory Endurance	Change from Baseline to 15 weeks
Secondary	Musculoskeletal Function	Assesment by peripheral muscular strength testing.	Change from Baseline to 15 weeks
Secondary	Change of laboratory parameters, metabolic profile assessment and systemic inflammatory.	IL-1beta, IL-1ra, IL-6, IL-8, IL-10 and TNF-alfa (pg/ml)	Change from Baseline to 15 weeks
Secondary	Exhaled Nitric Oxide	The fraction of eNO (exhaled nitric oxide) in air will be measured by chemiluminescence	Change from Baseline to 15 weeks
Secondary	Lung function (physiological parameter)	Forced vital capacity and liters in 1 second, Total lung capacity, diffusion of carbon dioxide	Change from Baseline to 15 weeks
Secondary	Physical Activity Questionnaire (IPAQ)	The level of physical activity will be assessed using the international questionnaire short-version physical activity (IPAQ). The continuous score allows assessing energy expenditure expressed in MET minutes/week. The IPAQ categorical classifies include: Insufficiently active (does not perform any physical activity); Sufficiently active (conducts vigorous activity at least three days a week >600 MET - 1400 MET); Very active (performs more than three days per week of vigorous activity 1500 MET - 3000 MET)	Change from Baseline to 15 weeks
Secondary	Endothelial function	Endothelial function will be assessed by flow-mediated dilation (FMD)	Change from Baseline to 15 weeks