Homebased Monitoring Cardiac Rehabilitation Program

NCT ID: NCT02796404

Last Updated: 2016-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Homebased cardiac rehabilitation program

Homebased Cardiac rehabilitation program with monitoring vest and mixed surveillance.

Group Type EXPERIMENTAL

Homebased cardiac rehabilitation program

Intervention Type DEVICE

homebased cardiac rehabilitation program with monitoring vest Nuubo

Traditional cardiac rehabilitation program

Intervention Type OTHER

multidisciplinary intervention in cardiac rehabilitation gym

Traditional cardiac rehabilitation

Multidisciplinary program in a cardiac rehabilitation gym. Routine clinical practice

Group Type OTHER

Traditional cardiac rehabilitation program

Intervention Type OTHER

multidisciplinary intervention in cardiac rehabilitation gym

Interventions

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Homebased cardiac rehabilitation program

homebased cardiac rehabilitation program with monitoring vest Nuubo

Intervention Type DEVICE

Traditional cardiac rehabilitation program

multidisciplinary intervention in cardiac rehabilitation gym

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raquel Bravo, MD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Hospital Mediterráneo

Almería, Almería, Spain

Site Status RECRUITING

Hospital Reina Sofía

Córdoba, Córdoba, Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Raquel Bravo, MD

Role: CONTACT

34951291977

Facility Contacts

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Jose Francisco Chiquero, MD

Role: primary

Angela Heredia, MD

Role: primary

Gloria Luque, MD

Role: primary

34951291977

References

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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.

Reference Type DERIVED
PMID: 37593110 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33580174 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28219338 (View on PubMed)

Other Identifiers

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NUUBO

Identifier Type: -

Identifier Source: org_study_id

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