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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Combined Training Versus Aerobic Training Versus Respiratory Muscle Training in Patients With Pulmonary Hypertension: A Randomized, Controlled Clinical Trial.

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

Intervention / Treatment
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* Other: Physical activity


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Training<br>Combined Training with 2 types of physical activity | Other: Physical activity<br>* Effects of different physical activity programs<br>|
| Experimental: Standard Training<br>Physical activity with aerobic exercise | Other: Physical activity<br>* Effects of different physical activity programs<br>|
| Experimental: Respiratory Muscle Training<br>Respiratory muscle performance | Other: Physical activity<br>* Effects of different physical activity programs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional exercise capacity | Oxygen consumption measurement during cardiopulmonary test | Change from Baseline to 15 weeks | 
| 6 Minute Walking Test | Distance in meters | Change from Baseline to 15 weeks | 
| Incremental shuttle walking test | Distance in meters | Change from Baseline to 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic Nervous System | Assesment by Heat Rate Variability analysis | Change from Baseline to 15 weeks | 
| Respiratory Muscle Strength | Assesment by Test of Incremental Respiratory Endurance | Change from Baseline to 15 weeks | 
| Musculoskeletal Function | Assesment by peripheral muscular strength testing. | 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) | Change from Baseline to 15 weeks | 
| Exhaled Nitric Oxide | The fraction of eNO (exhaled nitric oxide) in air will be measured by chemiluminescence | 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 | 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) | Change from Baseline to 15 weeks | 
| Endothelial function | Endothelial function will be assessed by flow-mediated dilation (FMD) | Change from Baseline to 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary Exercise Test, Rehabilitation, Distance Traveled, Functional Capacity, Autonomic Nervous System