ClinicalTrials.gg
Status unknownNCT03476629PAHUpdated Nov 4, 2020

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

An interventional study of Physical activity in Pulmonary Arterial Hypertension, Cardiovascular Diseases and Respiratory Disease, sponsored by University of Nove de Julho. Status unknown at 1 site in Brazil. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-11-04.

Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jan 2016, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 48 studies in Pulmonary Arterial Hypertension with a site in Brazil — 12 open to participants now, 15 under way, 5 of them phase 3. Pulmonary Arterial Hypertension · Brazil.

Planned enrollment
36th of 41
45 · median 215
Started
2016
with 1 other
No phase
7 of 48
4 open now
Registered
19th of 48
by date
Lead sponsor
2 of 48
University of Nove de Julho

Among the 48 studies in Pulmonary Arterial Hypertension with a site in Brazil, this one is the 36th largest by planned enrollment of the 41 interventional ones that give a count, is one of 2 that started in 2016, is one of 7 with no phase, and was the 19th registered.

Pulmonary Arterial Hypertension

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

Browse Pulmonary Arterial Hypertension studies →

Open to participants now

12 of the 48 studies in Pulmonary Arterial Hypertension with a site in Brazil are open now. Recruiting first, the newest first:

7 more — sign in →

All 12 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 90 Pulmonary Arterial Hypertension studies recruiting now, 51 (57%) set no upper age limit and 24 (27%) stop at 75 or younger; 18 take children under 18; 11 take healthy volunteers.

This study: 20 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 48 studies in Pulmonary Arterial Hypertension with a site in Brazil, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

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

Keywords

  • Cardiopulmonary Exercise Test
  • Rehabilitation
  • Distance Traveled
  • Functional Capacity
  • Autonomic Nervous System
04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Combined Training

    Combined Training with 2 types of physical activity

    Other: Physical activity

  • Experimental
    Standard Training

    Physical activity with aerobic exercise

    Other: Physical activity

  • Experimental
    Respiratory Muscle Training

    Respiratory muscle performance

    Other: Physical activity

Interventions

  • OtherPhysical activity

    Effects of different physical activity programs

06

What researchers measure

Primary outcomes

  1. Functional exercise capacity

    Oxygen consumption measurement during cardiopulmonary test

    Time frame: Change from Baseline to 15 weeks

  2. 6 Minute Walking Test

    Distance in meters

    Time frame: Change from Baseline to 15 weeks

  3. Incremental shuttle walking test

    Distance in meters

    Time frame: Change from Baseline to 15 weeks

Secondary outcomes

  1. Autonomic Nervous System

    Assesment by Heat Rate Variability analysis

    Time frame: Change from Baseline to 15 weeks

  2. Respiratory Muscle Strength

    Assesment by Test of Incremental Respiratory Endurance

    Time frame: Change from Baseline to 15 weeks

  3. Musculoskeletal Function

    Assesment by peripheral muscular strength testing.

    Time frame: Change from Baseline to 15 weeks

  4. 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)

    Time frame: Change from Baseline to 15 weeks

  5. Exhaled Nitric Oxide

    The fraction of eNO (exhaled nitric oxide) in air will be measured by chemiluminescence

    Time frame: Change from Baseline to 15 weeks

  6. Lung function (physiological parameter)

    Forced vital capacity and liters in 1 second, Total lung capacity, diffusion of carbon dioxide

    Time frame: Change from Baseline to 15 weeks

  7. 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)

    Time frame: Change from Baseline to 15 weeks

  8. Endothelial function

    Endothelial function will be assessed by flow-mediated dilation (FMD)

    Time frame: Change from Baseline to 15 weeks

07

Study locations

1 of 1 sites recruiting
  • Santa Casa de São Paulo Hospital
    São Paulo, Sao Paulo, Brazil
    Recruiting
    • Flávia Navarro, Dr · Contact
08

References and documents

Publications

  • 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. PubMed 18277824 ↗
  • Schannwell CM, Steiner S, Strauer BE. Diagnostics in pulmonary hypertension. J Physiol Pharmacol. 2007 Nov;58 Suppl 5(Pt 2):591-602. PubMed 18204173 ↗
  • 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. PubMed 17199843 ↗
  • Rubin LJ. Primary pulmonary hypertension. N Engl J Med. 1997 Jan 9;336(2):111-7. doi: 10.1056/NEJM199701093360207. No abstract available. PubMed 8988890 ↗
  • 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. PubMed 26320113 ↗
  • 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. PubMed 19969471 ↗
  • 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. PubMed 15640315 ↗
  • 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. PubMed 17689235 ↗
  • 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. PubMed 20410828 ↗
  • 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. PubMed 19720810 ↗
  • 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. PubMed 15640333 ↗
  • 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. PubMed 17764445 ↗
  • 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. PubMed 15337703 ↗
  • 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. PubMed 16982941 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Jul 2017, 18 months.

Of 60 non-industry interventional studies with no phase under Pulmonary Arterial Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's 18 months is below that.

Counting every sponsor, half of 65 studies reached it within 42 months; a quarter within 18 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2018
First posted
Mar 26, 2018
StartActual
Jan 10, 2016
Primary completionActual
Jul 10, 2017
CompletionEst.
Dec 10, 2020
Last update
Nov 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03476629
Collaborators
University of Miami, Faculdade de Ciências Médicas da Santa Casa de São Paulo
Responsible party
LUCIANA MARIA MALOSA SAMPAIO (Professor of the Postgraduate Program in Rehabilitation Sciences, University of Nove de Julho) — Principal investigator
First posted
Mar 26, 2018
Start date
Jan 10, 2016
Primary completion
Jul 10, 2017
Completion
Dec 10, 2020 (estimated)
Last update
Nov 4, 2020

Study contacts

Luciana Malosá Sampaio, Professor
Contact
lucianamalosa@gmail.com
+551133859241
Etiene Farah Teixeira de Carvalho, Phd
Contact
eti_farah@hotmail.com
+551133859241
Luciana Malosá Sampaio, Professor
principal investigator · University of Nove de Julho

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion