Pulmonary Arterial HypertensionPAHNCT03476629
Effects of Different Types of Physical Training in Patients With Pulmonary Arterial Hypertension.
A study testing Physical activity in people with Pulmonary Arterial Hypertension and Cardiovascular Diseases, run by University of Nove de Julho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiratory Disease
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2016to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Santa Casa de São Paulo Hospital
São Paulo, São Paulo
Flávia Navarro, Dr
About this study
Official title: Effects of Combined Training Versus Aerobic Training Versus Respiratory Muscle Training in Patients With Pulmonary Hypertension: A Randomized, Controlled Clinical Trial.
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.
- Conditions
- Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiratory Disease, Hypertension, Pulmonary, Pulmonary Hypertension
- Being tested
- Physical activity
- Keywords
- Cardiopulmonary Exercise Test, Rehabilitation, Distance Traveled, Functional Capacity, Autonomic Nervous System
- Medical subject headings
- Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiration Disorders, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Effects of different physical activity programs
| Study group | Role | What they receive |
|---|---|---|
| Combined Training | Experimental | Combined Training with 2 types of physical activity Receives: Other: Physical activity |
| Standard Training | Experimental | Physical activity with aerobic exercise Receives: Other: Physical activity |
| Respiratory Muscle Training | Experimental | Respiratory muscle performance Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
Oxygen consumption measurement during cardiopulmonary test
Measured: Change from Baseline to 15 weeks
6 Minute Walking Test
Distance in meters
Measured: Change from Baseline to 15 weeks
Incremental shuttle walking test
Distance in meters
Measured: Change from Baseline to 15 weeks
Secondary outcomes (8)
Autonomic Nervous System
Assesment by Heat Rate Variability analysis
Measured: Change from Baseline to 15 weeks
Respiratory Muscle Strength
Assesment by Test of Incremental Respiratory Endurance
Measured: Change from Baseline to 15 weeks
Musculoskeletal Function
Assesment by peripheral muscular strength testing.
Measured: Change from Baseline to 15 weeks
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)
Measured: Change from Baseline to 15 weeks
Exhaled Nitric Oxide
The fraction of eNO (exhaled nitric oxide) in air will be measured by chemiluminescence
Measured: Change from Baseline to 15 weeks
Lung function (physiological parameter)
Forced vital capacity and liters in 1 second, Total lung capacity, diffusion of carbon dioxide
Measured: Change from Baseline to 15 weeks
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)
Measured: Change from Baseline to 15 weeks
Endothelial function
Endothelial function will be assessed by flow-mediated dilation (FMD)
Measured: Change from Baseline to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start10 Jan 2016
- Primary completion10 Jul 2017
- Study completion10 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Responsible party
- Principal investigator, LUCIANA MARIA MALOSA SAMPAIO, University of Nove de Julho
- Investigators
- Luciana Malosá Sampaio, Professor, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476629
- Sponsor's protocol ID
- PAH Rehabilitation
- Acronym
- PAH
- Status last verified
- Nov 2020
- First submitted
- 28 Feb 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 18277824Schannwell CM, Steiner S, Strauer BE. Diagnostics in pulmonary hypertension. J Physiol Pharmacol. 2007 Nov;58 Suppl 5(Pt 2):591-602.
PubMed 18204173Gabbay 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 17199843Rubin LJ. Primary pulmonary hypertension. N Engl J Med. 1997 Jan 9;336(2):111-7. doi: 10.1056/NEJM199701093360207. No abstract available.
PubMed 8988890Galie 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 26320113Arena 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 19969471Naeije 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 15640315Bauer 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 17689235Mainguy 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 20410828de 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 19720810Meyer 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 15640333Kabitz 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 17764445Velez-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 15337703Mereles 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Training Versus Aerobic Training Versus Respiratory Muscle Training in Patients With Pulmonary Hypertension: A Randomized, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03476629
- Acronym / sponsor ID
- PAH / PAH Rehabilitation
- Conditions
- Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiratory Disease, Hypertension, Pulmonary, Pulmonary Hypertension
- Keywords
- Cardiopulmonary Exercise Test, Rehabilitation, Distance Traveled, Functional Capacity, Autonomic Nervous System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- University of Miami, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Dec 2020 (estimated)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined Training | Experimental | Other: Physical activityCombined Training with 2 types of physical activity |
| Standard Training | Experimental | Other: Physical activityPhysical activity with aerobic exercise |
| Respiratory Muscle Training | Experimental | Other: Physical activityRespiratory muscle performance |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityEffects of different physical activity programs | Other | Combined Training, Respiratory Muscle Training, Standard Training |
Primary outcome
Functional exercise capacity
Time frame: Change from Baseline to 15 weeks
Oxygen consumption measurement during cardiopulmonary test
6 Minute Walking Test
Time frame: Change from Baseline to 15 weeks
Distance in meters
Incremental shuttle walking test
Time frame: Change from Baseline to 15 weeks
Distance in meters
8 secondary outcomes
Autonomic Nervous System
Time frame: Change from Baseline to 15 weeks
Respiratory Muscle Strength
Time frame: Change from Baseline to 15 weeks
Musculoskeletal Function
Time frame: Change from Baseline to 15 weeks
Change of laboratory parameters, metabolic profile assessment and systemic inflammatory.
Time frame: Change from Baseline to 15 weeks
Exhaled Nitric Oxide
Time frame: Change from Baseline to 15 weeks
Lung function (physiological parameter)
Time frame: Change from Baseline to 15 weeks
Physical Activity Questionnaire (IPAQ)
Time frame: Change from Baseline to 15 weeks
Endothelial function
Time frame: Change from Baseline to 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 18277824Desai 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.
- Background: PubMed 18204173Schannwell CM, Steiner S, Strauer BE. Diagnostics in pulmonary hypertension. J Physiol Pharmacol. 2007 Nov;58 Suppl 5(Pt 2):591-602.
- Background: PubMed 17199843Gabbay 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.
- Background: PubMed 8988890Rubin LJ. Primary pulmonary hypertension. N Engl J Med. 1997 Jan 9;336(2):111-7. doi: 10.1056/NEJM199701093360207. No abstract available.
- Background: PubMed 26320113Galie 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.
- Background: PubMed 19969471Arena 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.
- Background: PubMed 15640315Naeije 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.
- Background: PubMed 17689235Bauer 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.
- Background: PubMed 20410828Mainguy 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.
- Background: PubMed 19720810de 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.
- Background: PubMed 15640333Meyer 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.
- Background: PubMed 17764445Kabitz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana Malosá Sampaio, Professor principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Pulmonary Arterial Hypertension and Cardiovascular Diseases, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luciana Malosá Sampaio, Professor (+551133859241, lucianamalosa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: Change from Baseline to 15 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03476629, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.