Exercise Tolerance in Patients With Decompensated Heart Failure

NCT ID: NCT02122848

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-04-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bilevel

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

Group Type: EXPERIMENTAL

BiLevel

Intervention Type: DEVICE

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

Interventions

BiLevel

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

Intervention Type: DEVICE

Other Intervention Names

BiPAP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Sirio-Libanes

OTHER

Sponsor Role: lead

Responsible Party

Wellington Yamaguti

Wellington Pereira dos Santos Yamaguti

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wellington Yamaguti

Role: PRINCIPAL_INVESTIGATOR

Hospital Sirio-Libanes

Locations

Hospitalsiriolibanes

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Moraes IG, Kimoto KM, Fernandes MB, Grams ST, Yamaguti WP. Adjunctive Use of Noninvasive Ventilation During Exercise in Patients With Decompensated Heart Failure. Am J Cardiol. 2017 Feb 1;119(3):423-427. doi: 10.1016/j.amjcard.2016.10.025. Epub 2016 Nov 1.

Reference Type: DERIVED

PMID: 27939229 (View on PubMed)

Other Identifiers

hsl 2013-48

Identifier Type: -

Identifier Source: org_study_id