Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure

Study Overview
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Brief Summary
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The study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.

Detailed Description
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BACKGROUND: Heart failure (HF) is a cardiovascular syndrome with enormous impact on public health by high morbidity and mortality rates that are associated. Studies show that changes in striated skeletal muscle of those individuals, possibly caused by progressive physical inactivity, contribute to the construction of the pathophysiology of this disease, emphasizing the importance of exercise for these patients. Exercise programs can be traced safer and related form the actual functional capacity thereof. Cardiac rehabilitation it is a set of activities that aims to ensure that patients with heart disease the best conditions, especially physical. In this context, non-invasive ventilation (NIV) is an alternative to provide an improved tolerance during exercise in patients with HF. GOALS: Evaluate the effectiveness of the use of NIV association to aerobic exercise in exercise programs supervised during cardiac rehabilitation exercise tolerance and quality of life in patients with heart failure when compared to performing these exercises without ventilatory support. METHODS: This is a clinical trial, controlled, randomized and blind to be developed with patients arising out of the main Recife reference centers in the care of patients with heart failure. It will be conducted assessments of functional capacity made by cardiopulmonary exercise testing (CPET), the Glittre-ADL test and through the questionnaire Duke Activity Status Index (DASI), assessment of quality of life using the questionnaire Minnesota Living with Heart Failure (MLWHF), and finally, in order to determine a clinical change, will be used to Patient Global Impression of Change Scale (PGIS). EXPECTED RESULTS: This study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Bilevel Positive Pressure Airway
* Other: Heart rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sedentary adults diagnosed with heart failure of ischemic hypertensive or alcoholic etiology; Ejection fraction of the left ventricle smaller than 50% (LVEF <50%) assessed by echocardiography simple; Recent and functional class II and III by the New York Heart Association (NYHA); FEV1 <80% predicted and / or FEV1 / FVC> 70% predicted; Clinical stability; Ex-smokers for more than five years; No change in the class of drugs within three months prior to the beginning of the study. Exclusion Criteria: Patients with unstable angina; Myocardial infarction or heart surgery up to three months before the survey; FEV1 / FVC <70% predicted characterizing obstructive respiratory disorder; Respiratory diseases; Smoking; Hemodynamic instability; Trauma of recent face; Nausea and vomiting; Orthopedic and neurological diseases; Psychic changes that restrict them to respond to the questionnaire.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiopulmonary exercise testing<br>Assess whether people who wore noninvasive ventilation during aerobic exercise have greater functional capacity than those who did not wear. | Device: Bilevel Positive Pressure Airway<br>* Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week<br>Other: Heart rehabilitation<br>* Heart rehabilitation, for 12 weeks, 3 times a week<br>|
| Experimental: ADL Glitre test<br>Check that people who wore noninvasive ventilation during aerobic exercise have greater submaximal functional capacity than those who did not wear. Compare a ventilatory metabolic response of the ADL Glitre test with an six-minute walk test. . | Device: Bilevel Positive Pressure Airway<br>* Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week<br>Other: Heart rehabilitation<br>* Heart rehabilitation, for 12 weeks, 3 times a week<br>|
| Experimental: Minnesota Living with Heart Failure<br>Check if people undergoing heart rehabilitation has improved quality of life. | Device: Bilevel Positive Pressure Airway<br>* Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week<br>Other: Heart rehabilitation<br>* Heart rehabilitation, for 12 weeks, 3 times a week<br>|
| Experimental: Bioimpedance balance<br>Check if people undergoing heart rehabilitation has improved the body composition. | Device: Bilevel Positive Pressure Airway<br>* Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week<br>Other: Heart rehabilitation<br>* Heart rehabilitation, for 12 weeks, 3 times a week<br>|
| No Intervention: Six-minute walk test<br>Compare a ventilatory metabolic response of the six-minute walk test with an ADL Glitre test. | |
| Experimental: Metabolic ventilatory response<br>To verify if non-invasive ventilation during aerobic exercise modifies the ventilatory metabolic response in patients with heart failure. Check the metabolic ventilatory response during the Glittre ADL test and six-minute walk test. | Device: Bilevel Positive Pressure Airway<br>* Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week<br>Other: Heart rehabilitation<br>* Heart rehabilitation, for 12 weeks, 3 times a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary exercise testing | Change in functional capacity | Baseline and 12 weeks | 
| Glittre-ADL Test | Change in submaximal functional capacity | Baseline and 12 weeks | 
| Six-Minute Walk Test | Change in submaximal functional capacity | Baseline | 
| Ventilatory metabolic response during the 6-minute walk test (6MWT) and Glittre-ADL Test | Compare the ventilatory metabolic response of the six-minute walk test and Glittre-ADL Test | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minnesota Living with Heart Failure | Improved in quality of life | Baseline and 12 weeks | 
| Bioimpedance scale | Change in the body composition | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Noninvasive Ventilation, Positive- Pressure Respiration