Heart Function Tests
Conditions
Interventions
The study is a randomized, controlled, two-arm, single-blind clinical trial. A total of 42 participants with heart failure and reduced left ventricular ejection fraction will be divided into two grou
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Sponsors
Universidade de Pernambuco
Universidade Federal do Vale do São Francisco
LAFIC - Laboratório de Fisioterapia Cardiovascular
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Outpatient follow-up for at least 6 months. Functional class (NYHA) I, II or III. Stable, with no history of hospitalization or emergency care in the last 2 months. Taking medications prescribed in the outpatient clinic and without changes in the last two weeks. Left Ventricular Ejection Fraction - LVEF less than 40% (medical history or complementary exam in the last year). Age between 18 and 65 years. Both sexes. Body Mass Index (BMI) between 18.5 and 34.5 kg/m2
Exclusion criteria
Exclusion criteria: Echocardiographic findings in the initial evaluation that differ from the eligibility criteria. Hypertrophic cardiomyopathy with outflow tract obstruction. Acute inflammatory or infectious heart disease in the last year. Limiting lung disease (forced expiratory volume in 1 second less than 50%). Evidence of neoplasia or treatment with chemotherapy or radiotherapy in the last 6 months. Significant pulmonary arterial hypertension reported in echocardiogram or medical history. Chronic renal failure on dialysis. Cognitive limitation or clinical condition limiting exercise. Poor adaptation to the cycle ergometer. Pregnant women. Patient on a heart transplant list. Patient with atrial flutter or atrial fibrillation (persistent or permanent). Pacemaker wearer. Regular practice of moderate or high intensity exercise or participation in a cardiovascular rehabilitation program in the last 4 weeks. Uncontrolled systemic blood pressure (SBP > 180 mmHg and/or DBP > 110 mmHg). Surgical planning in the next 3 months. Myocardial revascularization or myocardial infarction in the last year. Smoker. Cardiopulmonary Exercise Test - CPET with one of the following findings: Significant ventricular arrhythmia induced by exertion (non-sustained ventricular tachycardia, frequent ventricular ectopias), 2nd or 3rd degree atrioventricular blocks, significant electrocardiographic alterations in the ST segment indicative of myocardial ischemia in high intensity of exertion, dyspnea disproportionate to exertion, precordial pain, presence of new crackles or wheezes in respiratory auscultation during examination, sustained reduction of blood pressure in exertion, failure to identify the second ventilatory threshold. Abusive use of alcohol. Significant valvulopathy (mitral or aortic stenosis or insufficiency)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect on functional capacity, measured by O2 consumption (VO2) in a cardiopulmonary exercise test, after a period of exercise of 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect on functional capacity, measured by O2 consumption (VO2) in a cardiopulmonary exercise test, after a 6-week period of physical training.;Response in cardiac function through myocardial strain after a training period of 6 and 12 weeks;Assessment of cardiac autonomic behavior, through analysis of heart rate variability, after a 6 and 12-week training period, in addition to response after a training session.;Endothelial function response, measured by flow-mediated dilation technique, after a training period of 6 and 12 weeks.;Assessment of lung function through spirometry, after 6 and 12 weeks of training;Subjective assessment of functional capacity using the Duke Activity Status Index (DASI) questionnaire, after 6 and 12 weeks of training;Quality of life assessment using the quality of life questionnaire (SF-36), after 6 and 12 weeks of training.;Nutritional assessment by eating behavior using the Three Factor Eating Questionnaire (TFEQ), and by self-reported appetite, which will be investigated using the Councilon Nutrition Appetite Questionnaire (CNAQ). Assessment after 6 and 12 weeks of training.;Assessment of muscle strength by handgrip strength test, using a manual digital dynamometer. The description of adequate (preserved) or inadequate (low) muscular strength will be based on the cutoff point of 27 kilogram-force (kgf) for men and 16 kgf for women. Measurements after 6 and 12 weeks of training.;Assessment of systemic blood pressure behavior through 24-hour ambulatory blood pressure measurement (ABPM), after 6 and 12 weeks of training.;Assessment of the prevalence of arrhythmias using 24-hour Holter monitoring, after 6 and 12 weeks of training;Characterization of adverse effects (hospitalization, emergency care or medication adjustment due to decompensated HF, chest pain or dyspnea disproportionate to exertion, new arrhythmias, emergence of musculoskeletal pain, which hinders or prevents the continuation of training, and death) during the training period | — |
Countries
Brazil
Contacts
Public ContactAntônio Silva
Universidade de Pernambuco
Outcome results
None listed