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Completed

NCT Number: NCT02122848

Exercise Tolerance in Patients With Decompensated Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospitalsiriolibanes

São Paulo, 01308-050, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilevel

Device

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

Other names: BiPAP

Primary outcomes

  1. Endurance time of exercise in cycle ergometer.

    Time frame: 4 days

Secondary outcomes

  1. Dyspnea

    Time frame: 4 days

    Dyspnea will be evaluated by means of the modified Borg scale before and after exercise.

Sponsors and collaborators

Lead sponsor

Hospital Sirio-Libanes

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 25, 2014
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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