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

November 3, 2020 updated by: LUCIANA MARIA MALOSA SAMPAIO, University of Nove de Julho

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil
        • Recruiting
        • Santa Casa de São Paulo Hospital
        • Contact:
          • Flávia Navarro, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic Nervous System
Time Frame: Change from Baseline to 15 weeks
Assesment by Heat Rate Variability analysis
Change from Baseline to 15 weeks
Respiratory Muscle Strength
Time Frame: Change from Baseline to 15 weeks
Assesment by Test of Incremental Respiratory Endurance
Change from Baseline to 15 weeks
Musculoskeletal Function
Time Frame: Change from Baseline to 15 weeks
Assesment by peripheral muscular strength testing.
Change from Baseline to 15 weeks
Change of laboratory parameters, metabolic profile assessment and systemic inflammatory.
Time Frame: Change from Baseline to 15 weeks
IL-1beta, IL-1ra, IL-6, IL-8, IL-10 and TNF-alfa (pg/ml)
Change from Baseline to 15 weeks
Exhaled Nitric Oxide
Time Frame: Change from Baseline to 15 weeks
The fraction of eNO (exhaled nitric oxide) in air will be measured by chemiluminescence
Change from Baseline to 15 weeks
Lung function (physiological parameter)
Time Frame: Change from Baseline to 15 weeks
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)
Time Frame: 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 from Baseline to 15 weeks
Endothelial function
Time Frame: Change from Baseline to 15 weeks
Endothelial function will be assessed by flow-mediated dilation (FMD)
Change from Baseline to 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Collaborators

University of Miami
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Investigators

  • Principal Investigator: Luciana Malosá Sampaio, Professor, University of Nove de Julho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2016

Primary Completion (ACTUAL)

July 10, 2017

Study Completion (ANTICIPATED)

December 10, 2020

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (ACTUAL)

March 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAH Rehabilitation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Physical activity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe