Exercise Tolerance in Patients With Decompensated Heart Failure

Hospital Sirio-Libanes

Status: Completed

Conditions: Heart Failure

Treatments: Device: BiLevel

Study type: Interventional

Funder types: Other

Identifiers

NCT02122848

hsl 2013-48

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of airway bilevel positive pressure on the improvement of exercise tolerance in patients with decompensated heart failure.

Full description

Heart failure causes limitation of functional capacity and worsening of exercise tolerance. The airway pressure as adjuvant of cardiac rehabilitation has demonstrated improvement of functional capacity, decrease of respiratory work, increase of oxygenation and pulmonary compliance. Objective: to evaluate the effectiveness of the bilevel positive airway pressure (BILEVEL) in the increase of exercise tolerance in patients with decompensated heart failure. Method: this is a cross-over randomized clinical trial, with individuals who will undergo a submaximal progressive exercise test of the lower limbs with a cycle-ergometer using continuous positive airway pressure (CPAP) and BILEVEL in a random order. Patients will also be evaluated using a health related quality of life questionnaire, pulmonary function test, inspiratory muscle and peripheral muscle strength tests. Hypothesis: The increase in exercise tolerance might be greater during the use of BILEVEL.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects who has heart failure functional class II or III of New York heart association
• over 18 years
• non-smokers
• without cognitive or motor deficit
• without vasoactive drugs or low doses
• without recent acute myocardial myocardium (<1 year)
• without recent cardiac surgery (<1 year)
• without pulmonary disease
• without bronchodilators

Exclusion criteria

• unstable angina
• atrial fibrillation and atrioventricular block third degree
• frequent vomiting
• respiratory instability while collecting data

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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16 participants in 1 patient group

Bilevel

Experimental group

Description:

The intervention will be performed using BiLevel ventilation mode with EPAP=10 cmH2O and a IPAP which manages 6-8ml/kg tidal volume.

Treatment:

Device: BiLevel