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Exercise Tolerance in Patients With Decompensated Heart Failure

Effects of Bilevel Positive Airway Pressure on Exercise Tolerance in Patients With Decompensated Heart Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02122848
Enrollment
16
Registered
2014-04-25
Start date
2014-04-30
Completion date
2015-04-30
Last updated
2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, Exercise tolerance, Noninvasive ventilation

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.

Interventions

DEVICEBiLevel

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

Sponsors

Hospital Sirio-Libanes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Endurance time of exercise in cycle ergometer.4 days

Secondary

MeasureTime frameDescription
Dyspnea4 daysDyspnea will be evaluated by means of the modified Borg scale before and after exercise.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026