Exercise and Noninvasive Ventilation in Heart Failure Patients
Impact of Noninvasive Ventilation With Two Levels of Pressure on Exercise Tolerance in Subjects With Heart Failure: Randomized and Controlled Clinical Trial.
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Mar 2013
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 10, 2014
CompletedFirst Posted
Study publicly available on registry
March 12, 2014
CompletedMarch 12, 2014
December 1, 2013
Same day
March 10, 2014
March 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Cardiopulmonary Exercise Test
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) .
Seven days
Study Arms (2)
noninvasive ventilation
EXPERIMENTALControl Group
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departamento de Fisioterapia da UFPE
Recife, Pernambuco, Brazil
Related Publications (2)
Olson TP, Johnson BD. Influence of cardiomegaly on disordered breathing during exercise in chronic heart failure. Eur J Heart Fail. 2011 Mar;13(3):311-8. doi: 10.1093/eurjhf/hfq177. Epub 2010 Oct 16.
PMID: 20952768RESULTCarvalho LA, Brandao DC, Campos SL, Vidal TMS, Remigio MI, Martins SM, Dornelas de Andrade A. Noninvasive Ventilation Before Maximum Exercise Test Increases Exercise Tolerance in Subjects With Heart Failure: A Crossover Study. Arch Phys Med Rehabil. 2017 May;98(5):849-855. doi: 10.1016/j.apmr.2016.09.129. Epub 2016 Oct 26.
PMID: 27794485DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Adjunto
Study Record Dates
First Submitted
March 10, 2014
First Posted
March 12, 2014
Study Start
March 1, 2013
Primary Completion
March 1, 2013
Study Completion
December 1, 2013
Last Updated
March 12, 2014
Record last verified: 2013-12