Homebased Monitoring Cardiac Rehabilitation Program

NCT02796404 | Unknown

• 1 other identifier: NUUBO
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 3

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.

Conditions

Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease

Keywords

home monitoring; cardiac monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Results of homebased cardiac rehabilitation monitoring a traditional cardiac rehabilitation program

  During 12 months

• Adherence to these programs

  3, 6 and 12 months

• Safety to these program

  During 12 months

Study Arms (2)

Homebased cardiac rehabilitation program

EXPERIMENTAL

Homebased Cardiac rehabilitation program with monitoring vest and mixed surveillance.

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

Traditional cardiac rehabilitation

OTHER

Multidisciplinary program in a cardiac rehabilitation gym. Routine clinical practice

Other: Traditional cardiac rehabilitation program

Interventions

Homebased cardiac rehabilitation program DEVICE

homebased cardiac rehabilitation program with monitoring vest Nuubo

Homebased cardiac rehabilitation program

Traditional cardiac rehabilitation program OTHER

multidisciplinary intervention in cardiac rehabilitation gym

Homebased cardiac rehabilitation program; Traditional cardiac rehabilitation

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Hospital Mediterráneo

Almería, Almería, Spain

RECRUITING

Hospital Reina Sofía

Córdoba, Córdoba, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, 29010, Spain

RECRUITING

Related Publications (3)

• Yang Z, Jia X, Li J, Mei Z, Yang L, Yan C, Han Y. Efficacy and Safety of Hybrid Comprehensive Telerehabilitation (HCTR) for Cardiac Rehabilitation in Patients with Cardiovascular Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Occup Ther Int. 2023 Aug 9;2023:5147805. doi: 10.1155/2023/5147805. eCollection 2023.

  PMID: 37593110 DERIVED

• 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.

  PMID: 33580174 DERIVED

• 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.

  PMID: 28219338 DERIVED

Study Officials

• Raquel Bravo, MD

  rbravoescobar@yahoo.es

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel Bravo, MD

CONTACT

34951291977; rbravoescobar@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 10, 2016
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 10, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)