Homebased Monitoring Cardiac Rehabilitation Program (NUUBO)

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Status: Unknown

Conditions: Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease

Treatments: Other: Traditional cardiac rehabilitation program; Device: Homebased cardiac rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT02796404

NUUBO

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 148 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Homebased cardiac rehabilitation program

Experimental group

Description:

Homebased Cardiac rehabilitation program with monitoring vest and mixed surveillance.

Treatment:

Other: Traditional cardiac rehabilitation program

Device: Homebased cardiac rehabilitation program

Traditional cardiac rehabilitation

Other group

Description:

Multidisciplinary program in a cardiac rehabilitation gym. Routine clinical practice

Treatment:

Other: Traditional cardiac rehabilitation program