Effects of HIIT in Tolerance to Exercise of Individuals With HF and Coexisting COPD

Study Overview
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Brief Summary
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INTRODUCTION: The complexity of the pathophysiology of heterogeneous diseases such as heart failure and obstructive pulmonary disease causes a different approach to these diseases or with a view as much as a better understanding of the same situations, with which the clinical profile of patients who are associated with an association is. It is known that regular physical training promotes progressive improvements in exercise tolerance, in the pulmonary ventilation / perfusion ratio and in respiratory function by strengthening. OBJECTIVE: To compare the effects of high-intensity interval training and continuous aerobic exercise, with peripheral endothelial function, brain natriuretic peptide levels, maximum exercise tolerance, distribution of lung volumes and quality of life of patients with obstructive pulmonary disease associated with heart failure. METHODS: This is a clinical, controlled, randomized and blinded trial. Peripheral endothelial function, tolerance to maximum and submaximal exercise, distribution of lung volumes, quality of life, presence of symptoms of depression and perception of clinical change will be evaluated. EXPECTED RESULTS: Incorporate into the care of these patients, new effective therapeutic approaches, of low cost and with greater technical and scientific evidence.

Official Title
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Heart Failure Associated With Chronic Obstructive Lung Disease and Maximum Exercise Tolerance: Evaluation of the Distribution and Pulmonary Deposition of Radioaerosol, Peripheral and Coronary Endothelial Function, Brain Natriuretic Peptide

Conditions
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Heart Failure, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: High-intensity interval training
* Other: Continuous aerobic training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sedentary individuals with Heart Failure of all etiologies; Diagnosed moderate and severe chronic obstructive pulmonary disease; Clinical stability; No change in the medication class within three months before the beginning of the research. Exclusion Criteria: Unstable angina; Myocardial infarction; Previous cardiac surgery up to three months before the beginning of the study; Hemodynamic instability; Orthopedic and neurological diseases; Psychological and/or mental impairment.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 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: Interval training<br>Interval training will consist of 10 minutes of warm-up between 40-50% of the peak oxygen consumption (VO2peak), followed by four to six repetitions of three-minute intervals between 80-90% of VO2peak and three minutes between 40-50% VO2peak and finally, five minutes of cooling down between 30-40% of VO2peak. | Other: High-intensity interval training<br>* Exercise with high-intensity intervals followed by active rest<br>|
| Active Comparator: Continuous training<br>The continuous aerobic training will consist of 10 minutes of warm-up with intensity between 40 and 50% of VO2peak, 20 minutes of conditioning between 60 and 70% of VO2peak and 5 minutes of cooling down between 30 and 40% of VO2peak. | Other: Continuous aerobic training<br>* Interval Moderate-intensity aerobic training without intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise tolerance | Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption. | 24 weeks | 
| Peripheral endothelial function | Evaluated by the peripheral arterial tonometry using the EndoPat 2000 device | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment: Short Form-36 questionnaire | Evaluated by the Short Form-36 questionnaire | 24 weeks | 
| Perception of clinical change | Evaluated by the Patient Global Impression of Change Scale which is a one-dimensional measure in which individuals can rate their associated improvement on a 7-item scale ranging from 1 = no changes to 7 = much better. | 24 weeks | 
| Distance covered in the six-minute walk test | Evaluated by the six-minute walk test | 24 weeks |