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

NCT03476629 | Unknown DMC

• 1 other identifier: PAH Rehabilitation
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Arterial Hypertension; Cardiovascular Diseases; Respiratory Disease; Hypertension, Pulmonary; Pulmonary Hypertension

Keywords

Cardiopulmonary Exercise Test; Rehabilitation; Distance Traveled; Functional Capacity; Autonomic Nervous System

Outcome Measures

Primary Outcomes (3)

• Functional exercise capacity

  Oxygen consumption measurement during cardiopulmonary test

  Change from Baseline to 15 weeks

• 6 Minute Walking Test

  Distance in meters

  Change from Baseline to 15 weeks

• Incremental shuttle walking test

  Distance in meters

  Change from Baseline to 15 weeks

Secondary Outcomes (8)

• Autonomic Nervous System

  Change from Baseline to 15 weeks

• Respiratory Muscle Strength

  Change from Baseline to 15 weeks

• Musculoskeletal Function

  Change from Baseline to 15 weeks

• Change of laboratory parameters, metabolic profile assessment and systemic inflammatory.

  Change from Baseline to 15 weeks

• Exhaled Nitric Oxide

  Change from Baseline to 15 weeks

Study Arms (3)

Combined Training

EXPERIMENTAL

Combined Training with 2 types of physical activity

Other: Physical activity

Standard Training

EXPERIMENTAL

Physical activity with aerobic exercise

Other: Physical activity

Respiratory Muscle Training

EXPERIMENTAL

Respiratory muscle performance

Other: Physical activity

Interventions

Physical activity OTHER

Effects of different physical activity programs

Combined Training; Respiratory Muscle Training; Standard Training

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• University of Miami: collaborator
• Faculdade de Ciências Médicas da Santa Casa de São Paulo: collaborator

Study Sites (1)

Santa Casa de São Paulo Hospital

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (14)

• 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.

  PMID: 18277824 BACKGROUND

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

  PMID: 18204173 BACKGROUND

• 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. doi: 10.1111/j.1445-5994.2006.01242.x.

  PMID: 17199843 BACKGROUND

• Rubin LJ. Primary pulmonary hypertension. N Engl J Med. 1997 Jan 9;336(2):111-7. doi: 10.1056/NEJM199701093360207. No abstract available.

  PMID: 8988890 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.

  PMID: 26320113 BACKGROUND

• 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.

  PMID: 19969471 BACKGROUND

• Naeije R. Breathing more with weaker respiratory muscles in pulmonary arterial hypertension. Eur Respir J. 2005 Jan;25(1):6-8. doi: 10.1183/09031936.04.00121004. No abstract available.

  PMID: 15640315 BACKGROUND

• Bauer R, Dehnert C, Schoene P, Filusch A, Bartsch 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. doi: 10.1016/j.rmed.2007.06.014. Epub 2007 Aug 6.

  PMID: 17689235 BACKGROUND

• 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.

  PMID: 20410828 BACKGROUND

• 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.

  PMID: 19720810 BACKGROUND

• Meyer FJ, Lossnitzer D, Kristen AV, Schoene AM, Kubler W, Katus HA, Borst MM. Respiratory muscle dysfunction in idiopathic pulmonary arterial hypertension. Eur Respir J. 2005 Jan;25(1):125-30. doi: 10.1183/09031936.04.00095804.

  PMID: 15640333 BACKGROUND

• 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. doi: 10.1042/CS20070238.

  PMID: 17764445 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000140724.90898.D3. Epub 2004 Aug 30.

  PMID: 15337703 BACKGROUND

• 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.

  PMID: 16982941 BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Cardiovascular Diseases; Respiration Disorders; Hypertension, Pulmonary

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Luciana Malosá Sampaio, Professor

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Malosá Sampaio, Professor

CONTACT

+551133859241; lucianamalosa@gmail.com

Etiene Farah Teixeira de Carvalho, Phd

CONTACT

+551133859241; eti_farah@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Postgraduate Program in Rehabilitation Sciences

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 26, 2018
• Study Start: January 10, 2016
• Primary Completion: July 10, 2017
• Study Completion: December 10, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

BR (1)