Effects of Different Types of Physical Training in Patients With Pulmonary Arterial Hypertension. (PAH)
Primary Purpose
Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiratory Disease
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Cardiopulmonary Exercise Test, Rehabilitation, Distance Traveled, Functional Capacity, Autonomic Nervous System
Eligibility Criteria
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.
Sites / Locations
- Santa Casa de São Paulo HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Combined Training
Standard Training
Respiratory Muscle Training
Arm Description
Combined Training with 2 types of physical activity
Physical activity with aerobic exercise
Respiratory muscle performance
Outcomes
Primary Outcome Measures
Functional exercise capacity
Oxygen consumption measurement during cardiopulmonary test
6 Minute Walking Test
Distance in meters
Incremental shuttle walking test
Distance in meters
Secondary Outcome Measures
Autonomic Nervous System
Assesment by Heat Rate Variability analysis
Respiratory Muscle Strength
Assesment by Test of Incremental Respiratory Endurance
Musculoskeletal Function
Assesment by peripheral muscular strength testing.
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)
Exhaled Nitric Oxide
The fraction of eNO (exhaled nitric oxide) in air will be measured by chemiluminescence
Lung function (physiological parameter)
Forced vital capacity and liters in 1 second, Total lung capacity, diffusion of carbon dioxide
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)
Endothelial function
Endothelial function will be assessed by flow-mediated dilation (FMD)
Full Information
NCT ID
NCT03476629
First Posted
February 28, 2018
Last Updated
November 3, 2020
Sponsor
University of Nove de Julho
Collaborators
University of Miami, Faculdade de Ciências Médicas da Santa Casa de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03476629
Brief Title
Effects of Different Types of Physical Training in Patients With Pulmonary Arterial Hypertension.
Acronym
PAH
Official Title
Effects of Combined Training Versus Aerobic Training Versus Respiratory Muscle Training in Patients With Pulmonary Hypertension: A Randomized, Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2016 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
December 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
University of Miami, Faculdade de Ciências Médicas da Santa Casa de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiratory Disease, Hypertension, Pulmonary, Pulmonary Hypertension
Keywords
Cardiopulmonary Exercise Test, Rehabilitation, Distance Traveled, Functional Capacity, Autonomic Nervous System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined Training
Arm Type
Experimental
Arm Description
Combined Training with 2 types of physical activity
Arm Title
Standard Training
Arm Type
Experimental
Arm Description
Physical activity with aerobic exercise
Arm Title
Respiratory Muscle Training
Arm Type
Experimental
Arm Description
Respiratory muscle performance
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Description
Effects of different physical activity programs
Primary Outcome Measure Information:
Title
Functional exercise capacity
Description
Oxygen consumption measurement during cardiopulmonary test
Time Frame
Change from Baseline to 15 weeks
Title
6 Minute Walking Test
Description
Distance in meters
Time Frame
Change from Baseline to 15 weeks
Title
Incremental shuttle walking test
Description
Distance in meters
Time Frame
Change from Baseline to 15 weeks
Secondary Outcome Measure Information:
Title
Autonomic Nervous System
Description
Assesment by Heat Rate Variability analysis
Time Frame
Change from Baseline to 15 weeks
Title
Respiratory Muscle Strength
Description
Assesment by Test of Incremental Respiratory Endurance
Time Frame
Change from Baseline to 15 weeks
Title
Musculoskeletal Function
Description
Assesment by peripheral muscular strength testing.
Time Frame
Change from Baseline to 15 weeks
Title
Change of laboratory parameters, metabolic profile assessment and systemic inflammatory.
Description
IL-1beta, IL-1ra, IL-6, IL-8, IL-10 and TNF-alfa (pg/ml)
Time Frame
Change from Baseline to 15 weeks
Title
Exhaled Nitric Oxide
Description
The fraction of eNO (exhaled nitric oxide) in air will be measured by chemiluminescence
Time Frame
Change from Baseline to 15 weeks
Title
Lung function (physiological parameter)
Description
Forced vital capacity and liters in 1 second, Total lung capacity, diffusion of carbon dioxide
Time Frame
Change from Baseline to 15 weeks
Title
Physical Activity Questionnaire (IPAQ)
Description
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)
Time Frame
Change from Baseline to 15 weeks
Title
Endothelial function
Description
Endothelial function will be assessed by flow-mediated dilation (FMD)
Time Frame
Change from Baseline to 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana Malosá Sampaio, Professor
Phone
+551133859241
Email
lucianamalosa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Etiene Farah Teixeira de Carvalho, Phd
Phone
+551133859241
Email
eti_farah@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana Malosá Sampaio, Professor
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Casa de São Paulo Hospital
City
São Paulo
State/Province
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flávia Navarro, Dr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18277824
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. Erratum In: J Cardiopulm Rehabil Prev. 2008 Mar-Apr;28(2):table of contents.
Results Reference
background
PubMed Identifier
18204173
Citation
Schannwell CM, Steiner S, Strauer BE. Diagnostics in pulmonary hypertension. J Physiol Pharmacol. 2007 Nov;58 Suppl 5(Pt 2):591-602.
Results Reference
background
PubMed Identifier
17199843
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. doi: 10.1111/j.1445-5994.2006.01242.x.
Results Reference
background
PubMed Identifier
8988890
Citation
Rubin LJ. Primary pulmonary hypertension. N Engl J Med. 1997 Jan 9;336(2):111-7. doi: 10.1056/NEJM199701093360207. No abstract available.
Results Reference
background
PubMed Identifier
26320113
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.
Results Reference
background
PubMed Identifier
19969471
Citation
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.
Results Reference
background
PubMed Identifier
15640315
Citation
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.
Results Reference
background
PubMed Identifier
17689235
Citation
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.
Results Reference
background
PubMed Identifier
20410828
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.
Results Reference
background
PubMed Identifier
19720810
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.
Results Reference
background
PubMed Identifier
15640333
Citation
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.
Results Reference
background
PubMed Identifier
17764445
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. doi: 10.1042/CS20070238.
Results Reference
background
PubMed Identifier
15337703
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. doi: 10.1161/01.CIR.0000140724.90898.D3. Epub 2004 Aug 30.
Results Reference
background
PubMed Identifier
16982941
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.
Results Reference
background
Learn more about this trial
Effects of Different Types of Physical Training in Patients With Pulmonary Arterial Hypertension.
We'll reach out to this number within 24 hrs