Effects of Different Types of Physical Training in Patients With Pulmonary Arterial Hypertension.
- Conditions
- Pulmonary Arterial HypertensionCardiovascular DiseasesHypertension, PulmonaryRespiratory DiseasePulmonary Hypertension
- Interventions
- Other: Physical activity
- Registration Number
- NCT03476629
- Lead Sponsor
- University of Nove de Julho
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Combined Training Physical activity Combined Training with 2 types of physical activity Standard Training Physical activity Physical activity with aerobic exercise Respiratory Muscle Training Physical activity Respiratory muscle performance
- Primary Outcome Measures
Name Time Method 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
Functional exercise capacity Change from Baseline to 15 weeks Oxygen consumption measurement during cardiopulmonary test
- Secondary Outcome Measures
Name Time Method Autonomic Nervous System Change from Baseline to 15 weeks Assesment by Heat Rate Variability analysis
Endothelial function Change from Baseline to 15 weeks Endothelial function will be assessed by flow-mediated dilation (FMD)
Respiratory Muscle Strength Change from Baseline to 15 weeks Assesment by Test of Incremental Respiratory Endurance
Exhaled Nitric Oxide Change from Baseline to 15 weeks The fraction of eNO (exhaled nitric oxide) in air will be measured by chemiluminescence
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
Musculoskeletal Function Change from Baseline to 15 weeks Assesment by peripheral muscular strength testing.
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)
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)
Trial Locations
- Locations (1)
Santa Casa de São Paulo Hospital
🇧🇷São Paulo, Sao Paulo, Brazil