Exercise Tolerance in Patients With Decompensated Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT02122848
• Lead Sponsor: Hospital Sirio-Libanes

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-20
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-25
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Endurance time of exercise in cycle ergometer.	4 days

Secondary Outcome Measures

Name	Time	Method
Dyspnea	4 days	Dyspnea will be evaluated by means of the modified Borg scale before and after exercise.

Trial Locations

Locations (1)

Hospitalsiriolibanes; 🇧🇷 São Paulo, Brazil