Clinical trial NCT03476629: Effects of Different Types of Physical Training in Patients With Pulmonary Arterial Hypertension.
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
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Cardiovascular Diseases
Respiratory Disease
Hypertension, Pulmonary
Pulmonary Hypertension
Keywords: Cardiopulmonary Exercise Test
Rehabilitation
Distance Traveled
Functional Capacity
Autonomic Nervous System
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: University of Miami
name: Faculdade de Ciências Médicas da Santa Casa de São Paulo
First posted: 2018-03-26
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Functional exercise capacity
timeFrame: Change from Baseline to 15 weeks
measure: 6 Minute Walking Test
timeFrame: Change from Baseline to 15 weeks
measure: Incremental shuttle walking test
timeFrame: Change from Baseline to 15 weeks
Secondary outcomes:
measure: Autonomic Nervous System
timeFrame: Change from Baseline to 15 weeks
measure: Respiratory Muscle Strength
timeFrame: Change from Baseline to 15 weeks
measure: Musculoskeletal Function
timeFrame: Change from Baseline to 15 weeks
measure: Change of laboratory parameters, metabolic profile assessment and systemic inflammatory.
timeFrame: Change from Baseline to 15 weeks
measure: Exhaled Nitric Oxide
timeFrame: Change from Baseline to 15 weeks
measure: Lung function (physiological parameter)
timeFrame: Change from Baseline to 15 weeks
measure: Physical Activity Questionnaire (IPAQ)
timeFrame: Change from Baseline to 15 weeks
measure: Endothelial function
timeFrame: Change from Baseline to 15 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Santa Casa de São Paulo Hospital
state: Sao Paulo
Study officials:
affiliation: University of Nove de Julho
name: Luciana Malosá Sampaio, Professor
role: PRINCIPAL_INVESTIGATOR
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