Exercise and Noninvasive Ventilation in Heart Failure Patients

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departamento de Fisioterapia da UFPE

Recife, Pernambuco, Brazil

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Noninvasive ventilation

Other

Ventilatory support with bilevel positive pressure was held for 30 minutes with the volunteer sitting comfortably. A fan with two pressure levels (Vivo 40 Bi-Level, General Electric Company), which was attached to the face of the individual through a face Macara ( Respironics), was initially adopted one of 15 cmH2O IPAP and EPAP was used 5 cmH2O, making admissible pressure of 10 cm H2O, where the IPAP would be increased, subject to the comfort of the patient until the patient reached a tidal volume of 6-8 ml / kg, not exceeding the maximum of 20 cmH2O for IPAP.

Primary outcomes

Cardiopulmonary Exercise Test

Time frame: 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) .

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

Impact of Noninvasive Ventilation With Two Levels of Pressure on Exercise Tolerance in Subjects With Heart Failure: Randomized and Controlled Clinical Trial.

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Mar 12, 2014
Registry last updated: Mar 12, 2014

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

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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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