Back to resultsExercise and Noninvasive Ventilation in Heart Failure Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
noninvasive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- Departamento de Fisioterapia da UFPE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
noninvasive ventilation
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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) .
Secondary Outcome Measures
Full Information
NCT ID
NCT02085122
First Posted
March 10, 2014
Last Updated
March 11, 2014
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT02085122
Brief Title
Exercise and Noninvasive Ventilation in Heart Failure Patients
Official Title
Impact of Noninvasive Ventilation With Two Levels of Pressure on Exercise Tolerance in Subjects With Heart Failure: Randomized and Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
noninvasive ventilation
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
noninvasive ventilation
Intervention Description
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 Outcome Measure Information:
Title
Cardiopulmonary Exercise Test
Description
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) .
Time Frame
Seven days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Departamento de Fisioterapia da UFPE
City
Recife
State/Province
Pernambuco
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
20952768
Citation
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.
Results Reference
result
PubMed Identifier
27794485
Citation
Carvalho 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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/
Description
Related Info
Learn more about this trial
Exercise and Noninvasive Ventilation in Heart Failure Patients
We'll reach out to this number within 24 hrs