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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiopulmonary exercise testing | Experimental | Assess whether people who wore noninvasive ventilation during aerobic exercise have greater functional capacity than those who did not wear. |
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| ADL Glitre test | Experimental | 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. . |
|
| Minnesota Living with Heart Failure | Experimental | Check if people undergoing heart rehabilitation has improved quality of life. |
|
| Bioimpedance balance | Experimental | Check if people undergoing heart rehabilitation has improved the body composition. |
|
| Six-minute walk test | No Intervention | Compare a ventilatory metabolic response of the six-minute walk test with an ADL Glitre test. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilevel Positive Pressure Airway | Device | Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the Clinics Federal University of Pernambuco | Recife | Pernambuco | 50670-901 | Brazil | ||
| Cardiopulmonary Physiotherapy Laboratory |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| D000072038 | Cardiac Rehabilitation |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Metabolic ventilatory response | Experimental | 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. |
|
| Heart rehabilitation | Other | Heart rehabilitation, for 12 weeks, 3 times a week |
|
| Baseline and 12 weeks |
| Recife |
| Pernambuco |
| 50740-560 |
| Brazil |
| D012138 |
| Respiratory Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |