Cardiovascular Diseases, Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Pulmonary Hypertension, Respiratory Disease
Conditions
Keywords
Cardiopulmonary Exercise Test, Rehabilitation, Distance Traveled, Functional Capacity, Autonomic Nervous System
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.
Interventions
OTHERPhysical activity
Effects of different physical activity programs
Sponsors
University of Miami
Faculdade de Ciências Médicas da Santa Casa de São Paulo
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional exercise capacity | Change from Baseline to 15 weeks | Oxygen consumption measurement during cardiopulmonary test |
| 6 Minute Walking Test | Change from Baseline to 15 weeks | Distance in meters |
| Incremental shuttle walking test | Change from Baseline to 15 weeks | Distance in meters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of laboratory parameters, metabolic profile assessment and systemic inflammatory. | Change from Baseline to 15 weeks | IL-1beta, IL-1ra, IL-6, IL-8, IL-10 and TNF-alfa (pg/ml) |
| Exhaled Nitric Oxide | Change from Baseline to 15 weeks | The fraction of eNO (exhaled nitric oxide) in air will be measured by chemiluminescence |
| Autonomic Nervous System | Change from Baseline to 15 weeks | Assesment by Heat Rate Variability analysis |
| Physical Activity Questionnaire (IPAQ) | Change from Baseline to 15 weeks | 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) |
| Endothelial function | Change from Baseline to 15 weeks | Endothelial function will be assessed by flow-mediated dilation (FMD) |
| Lung function (physiological parameter) | Change from Baseline to 15 weeks | Forced vital capacity and liters in 1 second, Total lung capacity, diffusion of carbon dioxide |
| Respiratory Muscle Strength | Change from Baseline to 15 weeks | Assesment by Test of Incremental Respiratory Endurance |
| Musculoskeletal Function | Change from Baseline to 15 weeks | Assesment by peripheral muscular strength testing. |
Countries
Brazil
Contacts
Primary ContactLuciana Malosá Sampaio, Professor
Backup ContactEtiene Farah Teixeira de Carvalho, Phd
Outcome results
None listed