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Clinical Trials/NCT02796404
NCT02796404
Unknown
Not Applicable

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

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud3 sites in 1 country148 target enrollmentAugust 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Enrollment
148
Locations
3
Primary Endpoint
Effectiveness measured by exercise testing and control of cardiovascular risk factors
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
June 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Eligibility Criteria

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).

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.

Outcomes

Primary Outcomes

Effectiveness measured by exercise testing and control of cardiovascular risk factors

Time Frame: During 12 months

functional capacity obtained by exercise testing and control of cardiovascular risk factors.

Secondary Outcomes

  • Adherence to these programs(3, 6 and 12 months)
  • Results of homebased cardiac rehabilitation monitoring a traditional cardiac rehabilitation program(During 12 months)
  • Safety to these program(During 12 months)

Study Sites (3)

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