Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease Clinical Trial
— NUUBOOfficial 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
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.
| Status | Recruiting |
| Enrollment | 148 |
| Est. completion date | June 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Mediterráneo | Almería | |
| Spain | Hospital Reina Sofía | Córdoba | |
| Spain | Hospital Universitario Virgen de la Victoria | Malaga |
| Lead Sponsor | Collaborator |
|---|---|
| Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | Yes |