Ventilatory Support Associated With Exercise in Heart Failure

Study Overview
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Brief Summary
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Due to the symptoms of heart failure (HF), as dyspnea and fatigue, patients have a reduced functional capacity, evidenced during usual daily activities and exercises. The Cardiac Rehabilitation with emphasis on resistance and aerobic exercises performed in the same session (concurrent training), can be added to pharmacological treatment as improvement strategy in functional capacity and quality of life.

Detailed Description
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A randomized clinical trial, divided into two stages will be held. In step 1 the function will be assessed by the 6-minute walk test, spirometry, and questionnaires to evaluate quality of life. After fulfilled the series of assessments individuals will be randomly divided into two groups, with group 1 (control) will hold only one interval aerobic exercise program on treadmill and group 2 (intervention) will hold a combined exercise program for prior use of ventilatory support noninvasive. For both groups will be held an aerobic exercise program associated with resistance exercise for 12 weeks. The first two weeks will be considered in period. In the 10 weeks following both groups maintain the preset exercise program gradually. In the intervention group will be added before the exercise program the use of noninvasive ventilation for 30 minutes.

Official Title
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Noninvasive Ventilatory Support Associated With Concurrent Training in Improved Functional Capacity and Quality of Life in Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Other: noninvasive ventilatory support
* Other: interval training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Will be included 60 patients of both sexes, adults with medical diagnosis divided into two groups: Group A consisted of 30 patients use non-invasive ventilation added to interval training and group B consisted of 30 patients also only use interval training. Exclusion Criteria: Will be excluded from the study patients who have chest pain (angina), arrhythmias, spo2 ≤ 90%, hypertension or hypotension, neurological or osteoarticular disease preventing the ambulation of these individuals.
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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ventilatory support<br>noninvasive ventilatory support to 5cmH2O used before the session of interval training and resistance exercises performed three times a week for 12 weeks | Other: noninvasive ventilatory support<br>* noninvasive ventilatory support with 5-minute ramp and positive end expiratory pressure (PEEP) of 5 cm H2O for 30 minutes, then there will be the interval aerobic training on a treadmill added to resistance exercises<br>* Other names: CPAP of redmed brand;Other: interval training<br>* interval training<br>* Other names: concurrent training;|
| Active Comparator: interval training<br>sessions of interval training and resistance exercises performed three times a week for 12 weeks | Other: interval training<br>* interval training<br>* Other names: concurrent training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SIX MINUTES WALK TEST | Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction. | AFTER 12 WEEKS FOLLOW | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| double product | Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction. | AFTER 12 WEEKS FOLLOW | 
| spirometry | Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction. | AFTER 12 WEEKS FOLLOW | 
| minnesota questionnaire | Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction. | AFTER 12 WEEKS FOLLOW | 
| SF-36 questionnaire | Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction. | AFTER 12 WEEKS FOLLOW | 
| Functional Independence Measure questionnaire | Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction. | AFTER 12 WEEKS FOLLOW |