Homebased Monitoring Cardiac Rehabilitation Program

Study Overview
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Brief Summary
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The current state of mobile communication and technology is a tool to support home programs for chronic disease management, useful to facilitate access to these types of programs, because the investigators could obtain telematics information about the parameters, reducing cardiovascular risk factors and cardiovascular morbidity and mortality.

Detailed Description
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The current state of mobile communication and technology is a tool to support home programs for chronic disease management, useful to facilitate access to these types of programs, because the investigators could obtain telematics information about the parameters, reducing cardiovascular risk factors and cardiovascular morbidity and mortality. Once the patient qualifies for inclusion in the study and has signed informed consent it is included in a list where randomized 7 patients in the experimental group (home-based cardiac rehabilitation Nuubo monitoring vest) and 7 patients are assigned to traditional cardiac rehabilitation group.

Official Title
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Effectiveness of a Homebased Cardiac Rehabilitation Program of Mixed Surveillance Using NUUBO Monitoring Vest in Patients With Ischemic Heart Disease at Moderate Cardiovascular Risk

Conditions
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Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease

Intervention / Treatment
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* Device: Homebased cardiac rehabilitation program
* Other: Traditional cardiac rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All of them: Age ≤ 80 years. Stable Ischemic heart disease, revascularized by angioplasty or underwent surgery by coronary bypass <= one year from the acute episode. Good cognitive level. Ability to perform aerobic exercise tape or cycle ergometer. Understand the use of a mobile Smartphone or Tablet. Signature of informed consent. And at least one of the following: Ventricular dysfunction by Ejection Fraction (FE) 40 - 50%. Functional capacity 5-7 metabolic equivalents (METS). Raising the blood pressure with the effort. Exclusion Criteria: Presence of malignant arrhythmias such as ventricular fibrillation outside the acute phase of Acute myocardial infarction (AMI) (> 24 h after AMI), ventricular tachycardia, Atrioventricular block of 2nd degree and 3rd degree, Atrial fibrilation (FA) in patients with Wolf Parkinson White, fibrillation or paroxysmal atrial flutter with response ventricular quickly and hemodynamic deterioration, premature ventricular contractions increases during exertion, paroxysmal supraventricular tachycardia uncontrolled. Previous infarcts. Hypotensive response to exercise. Myocardial Ischemia valued at exercise test. Unstable Angina. Nonrevascularizable disease. Poorly controlled hypertension baseline. Killip III and IV Killip. No collaborator. Valvular heart disease associated. Pacemaker or Implantable Cardioverter Defibrillator. Pathology of musculoskeletal, neurological or breathing that impair the ability of prolonged ambulation.

Ages Eligible for Study
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Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homebased cardiac rehabilitation program<br>Homebased Cardiac rehabilitation program with monitoring vest and mixed surveillance. | Device: Homebased cardiac rehabilitation program<br>* homebased cardiac rehabilitation program with monitoring vest Nuubo<br>Other: Traditional cardiac rehabilitation program<br>* multidisciplinary intervention in cardiac rehabilitation gym<br>|
| Other: Traditional cardiac rehabilitation<br>Multidisciplinary program in a cardiac rehabilitation gym. Routine clinical practice | Other: Traditional cardiac rehabilitation program<br>* multidisciplinary intervention in cardiac rehabilitation gym<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness measured by exercise testing and control of cardiovascular risk factors | functional capacity obtained by exercise testing and control of cardiovascular risk factors. | During 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of homebased cardiac rehabilitation monitoring a traditional cardiac rehabilitation program | comparing the results of functional capacity measured by exercise testing and control of cardiovascular risk factors between the two groups | During 12 months | 
| Adherence to these programs | see adherence to these program at 3, 6 months and a year depending on the habit of exercise and control of cardiovascular risk factors. | 3, 6 and 12 months | 
| Safety to these program | See the safety of home cardiac rehabilitation program of mixed surveillance compared to traditional cardiac rehabilitation program to checking the existence of adverse cardiac events. | During 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home monitoring, cardiac monitoring