Exercise and Noninvasive Ventilation in Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: noninvasive ventilation

• Registration Number: NCT02085122
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

Introduction: Dyspnea and fatigue determine exercise intolerance in heart failure (HF) subjects, hampering performance in activities of daily living. In this context, noninvasive ventilation (NIV) has been used to minimize such impairment, increasing functional capacity Aim: To evaluate the impact of NIV on exercise performance in HF individuals. Methods: A randomized crossover clinical trial with allocation concealment consisted of two experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30 minutes of bi-level ventilation was performed. Any type of ventilator support was offered during control phase. Functional capacity was assessed by cardiopulmonary exercise test on a treadmill.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-03
• Status Verified: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-11
• Last Update Submitted: 2014-03-11
• Study First Posted: 2014-03-12
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Both sexes, 18-60 years
• body mass index (BMI) <30 kg/m2
• functional class II-III according to the New York Heart Association
• of the echocardiogram últiimos 6 months showing ejection fraction (LVEF) ≤ 45% - echocardiogram of six months showing cardiac hypertrophy (left Ventricular Diastolic Diameter (LVDD)> 55mm
• Diameter Systolic left Ventricular (LVSD)> 45mm )
• optimized from the point of view of drug and (6) clinical stability

Exclusion Criteria

• (1) unstable angina, myocardial infarction or heart surgery three months before the beginning of the research

  (2) chronic orthopedic, infectious or metabolic diseases

  (3) FEV1/FVC <70% predicted characterizing obstructive respiratory disorder; (4) active smokers

  (5) Limitation on the use of NIV: claustrophobia, inability to remain with their mouths closed, abdominal distention, hemodynamic instability, heart rate (HR) <60 bpm, recent trauma, nausea and vomiting face

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
noninvasive ventilation	noninvasive ventilation	-

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary Exercise Test	Seven days	Cardiopulmonary exercise testing ( CPET ) was performed with symptom-limited ramp protocol (Silva et al . , 2003 ) treadmill ( Centurium 300 Micromed, Brazil ) through ErgoPC Elite ® software associated with electrocardiogram ( Micromed , Brazil ) with 12 channels . The test was performed under standard conditions of temperature, pressure and humidity ( STPD ) , breath-by - breath, being voluntary breathing in a face mask leak during exercise . Before each test the calibration of the equipment for pressure and gas volume was carried out. To ensure that patients reached the maximum effort during the examination were considered tests where patients present a respiratory exchange ratio ( R) ≥ 1.1 ( ARENA , et al 2011) .

Trial Locations

Locations (1)

Departamento de Fisioterapia da UFPE; 🇧🇷 Recife, Pernambuco, Brazil