Thromboembolism
Conditions
Interventions
This is a two-arm, randomized, controlled clinical study, 52 patients diagnosed with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension will be recruited to undergo Card
E02.760.169.063.500
G11.427.410.698.277.311.250
E02.760.169.063.500.387.875
E02.760.169.063.500.387.250
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: These are patients with a previous diagnosis of Pulmonary Arterial Hypertension or non-surgical Chronic Thromboembolic Pulmonary Hypertension or residual post-thromboendarterectomy; Modified New York Heart Association (NYHA) functional class I, II and III; Specific pharmacological treatment for Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension optimized and available in Brazil and stable for at least 3 months or at least 6 months post-thromboendarterectomy
Exclusion criteria
Exclusion criteria: Presence of syncope in the last 30 days or signs and symptoms of clinical instability in the last month, worsening of dyspnea, pre-syncope or need for increased diuretics due to edema or hospitalization; Other diagnosis of Pulmonary Hypertension group II, III and V; Functional class IV; Musculoskeletal diseases that contraindicate or impair carrying out exercise testing on a cycle ergometer or carrying out rehabilitation; Need for additional specific therapy during the rehabilitation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the proportion of adverse events during visits for high-intensity interval training and moderate-intensity constant load training. The result will be evaluated by comparing the proportion of adverse events between the groups. Adverse events evaluated at each visit will be: desaturation = 4 points, SpO2 3 – moderate), decompensation of Pulmonary Hypertension (persistent increase in baseline dyspnea with change in functional class, water retention with need to increase the use of diuretics after 24 hours of each training session, need for hospitalization). Events not related to training that will be analyzed: respiratory and gastrointestinal infections and herpes zoster. The following will be considered as severe/serious adverse events (AES): syncope, chest pain (Borg = 5) during aerobic exercise persistence of dyspnea/fatigue after 24 hours of training in relation to baseline, maintaining the standard after 3 sessions, worsening of the class functional for 2 consecutive weeks (NYHA I to II or II to III), arrhythmia (atrial fibrillation, flutter and/or ventricular tachycardia) confirmed by electrocardiogram and/or hospitalization.;It is expected to find an increase in V’O2 peak = 1.5 ml/kg/min for a difference = 100ml/min, verified by the incremental Cardiopulmonary Exercise Test carried out pre and post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find an increase in tLIM = 60s, verified by the Cardiopulmonary Exercise Test with constant load carried out pre and post-intervention;It is expected to find an increase in the distance walked greater than 38m, verified by the 6-minute Walk Test carried out pre and post-intervention;It is expected to find a reduction in lactacidemia, an increase in peripheral oxygen extraction and an improvement in gas exchange, assessed by collecting blood gases from the ear lobe and NIRS during the pre- and post-rehabilitation Cardiopulmonary Exercise Test. The expected result will be evaluated by the significant difference between the means comparing pre and post rehabilitation;It is expected to find an improvement in right ventricular function, assessed by the Echocardiogram performed pre and post-intervention. The expected result will be evaluated by the significant difference between the means comparing pre and post rehabilitation;It is expected to find an improvement in quality of life with a reduction of 9 points using the EMPHASIS-10 questionnaire, a questionnaire with 10 questions scored from 0 to 5 that will be carried out pre and post-intervention. Comparing individually and on group average;It is expected to find an improvement in the oxidative response through metabolomics analysis, verified by the analysis of these markers in blood collected from a peripheral vein pre and post-intervention. Comparing individually and on group average. The expected result will be evaluated by the significant difference between the means comparing pre and post rehabilitation;It is expected to find an improvement in muscle strength, verified by performing the Isokinetic test pre and post rehabilitation. Comparing individually and on group average. The expected result will be evaluated by the significant difference between the means comparing pre and post rehabilitation | — |
Countries
Brazil
Contacts
Public ContactEloara Campos
Universidade Federal de São Paulo
Outcome results
None listed