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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years - 70 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03476629
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Nove de Julho
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Luciana Malosá Sampaio, Professor
Principal Investigator Affiliation University of Nove de Julho
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Brazil
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiratory Disease, Hypertension, Pulmonary, Pulmonary Hypertension
Additional Details

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.

Arms & Interventions

Arms

Experimental: Combined Training

Combined Training with 2 types of physical activity

Experimental: Standard Training

Physical activity with aerobic exercise

Experimental: Respiratory Muscle Training

Respiratory muscle performance

Interventions

Other: - Physical activity

Effects of different physical activity programs

Contact a Trial Team

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International Sites

Santa Casa de São Paulo Hospital, São Paulo, Sao Paulo, Brazil

Status

Recruiting

Address

Santa Casa de São Paulo Hospital

São Paulo, Sao Paulo,

Site Contact

Flávia Navarro, Dr

lucianamalosa@gmail.com

+551133859241

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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