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

U

University of Nove de Julho

Status

Unknown

Conditions

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

Treatments

Other: Physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT03476629
PAH Rehabilitation

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

45 participants in 3 patient groups

Combined Training
Experimental group
Description:
Combined Training with 2 types of physical activity
Treatment:
Other: Physical activity
Standard Training
Experimental group
Description:
Physical activity with aerobic exercise
Treatment:
Other: Physical activity
Respiratory Muscle Training
Experimental group
Description:
Respiratory muscle performance
Treatment:
Other: Physical activity

Trial contacts and locations

1

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Central trial contact

Luciana Malosá Sampaio, Professor; Etiene Farah Teixeira de Carvalho, Phd

Data sourced from clinicaltrials.gov

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