Clinical trial NCT02796404: Homebased Monitoring Cardiac Rehabilitation Program
Official title: Effectiveness of a Homebased Cardiac Rehabilitation Program of Mixed Surveillance Using NUUBO Monitoring Vest in Patients With Ischemic Heart Disease at Moderate Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease
Keywords: home monitoring
cardiac monitoring
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 148
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).
* 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.

Primary outcomes:
measure: Effectiveness measured by exercise testing and control of cardiovascular risk factors
timeFrame: During 12 months
Secondary outcomes:
measure: Results of homebased cardiac rehabilitation monitoring a traditional cardiac rehabilitation program
timeFrame: During 12 months
measure: Adherence to these programs
timeFrame: 3, 6 and 12 months
measure: Safety to these program
timeFrame: During 12 months
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Hospital Mediterráneo
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
Study officials:
affiliation: rbravoescobar@yahoo.es
name: Raquel Bravo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bravo-Escobar R, Gonzalez-Represas A, Gomez-Gonzalez AM, Heredia-Torres A. Effectiveness of e-Health cardiac rehabilitation program on quality of life associated with symptoms of anxiety and depression in moderate-risk patients. Sci Rep. 2021 Feb 12;11(1):3760. doi: 10.1038/s41598-021-83231-y.
citation: Bravo-Escobar R, Gonzalez-Represas A, Gomez-Gonzalez AM, Montiel-Trujillo A, Aguilar-Jimenez R, Carrasco-Ruiz R, Salinas-Sanchez P. Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: A randomised, controlled clinical trial. BMC Cardiovasc Disord. 2017 Feb 20;17(1):66. doi: 10.1186/s12872-017-0499-0.