Heart Failure
Conditions
Keywords
Heart Failure, Noninvasive Ventilation, Positive- Pressure Respiration
Brief summary
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
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.
Interventions
DEVICEBilevel Positive Pressure Airway
Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week
OTHERHeart rehabilitation
Heart rehabilitation, for 12 weeks, 3 times a week
Sponsors
Universidade Federal de Pernambuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary exercise testing | Baseline and 12 weeks | Change in functional capacity |
| Glittre-ADL Test | Baseline and 12 weeks | Change in submaximal functional capacity |
| Six-Minute Walk Test | Baseline | Change in submaximal functional capacity |
| Ventilatory metabolic response during the 6-minute walk test (6MWT) and Glittre-ADL Test | Baseline and 12 weeks | Compare the ventilatory metabolic response of the six-minute walk test and Glittre-ADL Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minnesota Living with Heart Failure | Baseline and 12 weeks | Improved in quality of life |
| Bioimpedance scale | Baseline and 12 weeks | Change in the body composition |
Countries
Brazil
Outcome results
None listed