Clinical trial NCT02811146: Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Noninvasive Ventilation
Positive- Pressure Respiration
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiopulmonary exercise testing
timeFrame: Baseline and 12 weeks
measure: Glittre-ADL Test
timeFrame: Baseline and 12 weeks
measure: Six-Minute Walk Test
timeFrame: Baseline
measure: Ventilatory metabolic response during the 6-minute walk test (6MWT) and Glittre-ADL Test
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Minnesota Living with Heart Failure
timeFrame: Baseline and 12 weeks
measure: Bioimpedance scale
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Cardiopulmonary Physiotherapy Laboratory
state: Pernambuco
city: Recife
country: Brazil
facility: Hospital of the Clinics Federal University of Pernambuco
state: PE
Study officials:
References: