Back to resultsExercise Tolerance in Patients With Decompensated Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
BiLevel
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Exercise tolerance, Noninvasive ventilation
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
Sites / Locations
- Hospitalsiriolibanes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bilevel
Arm Description
The intervention will be performed using BiLevel ventilation mode with EPAP=10 cmH2O and a IPAP which manages 6-8ml/kg tidal volume.
Outcomes
Primary Outcome Measures
Endurance time of exercise in cycle ergometer.
Secondary Outcome Measures
Dyspnea
Dyspnea will be evaluated by means of the modified Borg scale before and after exercise.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02122848
Brief Title
Exercise Tolerance in Patients With Decompensated Heart Failure
Official Title
Effects of Bilevel Positive Airway Pressure on Exercise Tolerance in Patients With Decompensated Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Exercise tolerance, Noninvasive ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilevel
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
BiLevel
Other Intervention Name(s)
BiPAP
Intervention Description
The intervention will be performed using BiLevel ventilation mode with EPAP=10 cmH2O and a IPAP which manages 6-8ml/kg tidal volume.
Primary Outcome Measure Information:
Title
Endurance time of exercise in cycle ergometer.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Dyspnea
Description
Dyspnea will be evaluated by means of the modified Borg scale before and after exercise.
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wellington Yamaguti
Organizational Affiliation
Hospital Sirio-Libanes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospitalsiriolibanes
City
São Paulo
ZIP/Postal Code
01308-050
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
27939229
Citation
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.
Results Reference
derived
Learn more about this trial
Exercise Tolerance in Patients With Decompensated Heart Failure
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