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

Sponsor

University of Nove de Julho (Other)

Overall Status

Recruiting

CT.gov ID

NCT03476629

Collaborator

University of Miami (Other), Faculdade de Ciências Médicas da Santa Casa de São Paulo (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension Cardiovascular Diseases Respiratory Disease Hypertension, Pulmonary Pulmonary Hypertension	Other: Physical activity	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2016

Actual Primary Completion Date :

Jul 10, 2017

Anticipated Study Completion Date :

Dec 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combined Training Combined Training with 2 types of physical activity	Other: Physical activity Effects of different physical activity programs
Experimental: Standard Training Physical activity with aerobic exercise	Other: Physical activity Effects of different physical activity programs
Experimental: Respiratory Muscle Training Respiratory muscle performance	Other: Physical activity Effects of different physical activity programs

Arm

Intervention/Treatment

Experimental: Combined Training

Combined Training with 2 types of physical activity

Other: Physical activity

Effects of different physical activity programs

Experimental: Standard Training

Physical activity with aerobic exercise

Other: Physical activity

Effects of different physical activity programs

Experimental: Respiratory Muscle Training

Respiratory muscle performance

Other: Physical activity

Effects of different physical activity programs

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Autonomic Nervous System [Change from Baseline to 15 weeks]
Assesment by Heat Rate Variability analysis
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.
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
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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.