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Homebased Monitoring Cardiac Rehabilitation Program (NUUBO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02796404
Recruitment Status : Unknown
Verified May 2016 by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
Recruitment status was:  Recruiting
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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.

Condition or disease Intervention/treatment Phase
Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease Device: Homebased cardiac rehabilitation program Other: Traditional cardiac rehabilitation program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Homebased cardiac rehabilitation program
Homebased Cardiac rehabilitation program with monitoring vest and mixed surveillance.
Device: Homebased cardiac rehabilitation program
homebased cardiac rehabilitation program with monitoring vest Nuubo

Other: Traditional cardiac rehabilitation program
multidisciplinary intervention in cardiac rehabilitation gym

Traditional cardiac rehabilitation
Multidisciplinary program in a cardiac rehabilitation gym. Routine clinical practice
Other: Traditional cardiac rehabilitation program
multidisciplinary intervention in cardiac rehabilitation gym




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Results of homebased cardiac rehabilitation monitoring a traditional cardiac rehabilitation program [ Time Frame: During 12 months ]
    comparing the results of functional capacity measured by exercise testing and control of cardiovascular risk factors between the two groups

  2. Adherence to these programs [ Time Frame: 3, 6 and 12 months ]
    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. Safety to these program [ Time Frame: During 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796404


Contacts
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Contact: Raquel Bravo, MD 34951291977 rbravoescobar@yahoo.es

Locations
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Spain
Hospital Mediterráneo Recruiting
Almería, Spain
Contact: Jose Francisco Chiquero, MD         
Principal Investigator: Jose Francisco Chiquero, MD         
Sub-Investigator: Jose Ramon Vicente, MD         
Sub-Investigator: Carlos Gómez, MD         
Sub-Investigator: Beatriz Vargas         
Sub-Investigator: Cristina Vicario         
Sub-Investigator: Ines Maillo         
Hospital Reina Sofía Recruiting
Córdoba, Spain
Contact: Angela Heredia, MD         
Principal Investigator: Angela Heredia, MD         
Sub-Investigator: José López, MD         
Sub-Investigator: Pilar Cano, MD         
Sub-Investigator: Milagros Ramos         
Hospital Universitario Virgen de la Victoria Recruiting
Malaga, Spain, 29010
Contact: Gloria Luque, MD    34951291977    gloria.luque@fimabis.org   
Sub-Investigator: Adela Gómez, MD         
Sub-Investigator: Angel Montiel, MD         
Sub-Investigator: Rafael Aguilar         
Sub-Investigator: Rosa Carrasco         
Principal Investigator: Raquel Bravo, MD         
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Investigators
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Principal Investigator: Raquel Bravo, MD rbravoescobar@yahoo.es

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT02796404     History of Changes
Other Study ID Numbers: NUUBO
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
home monitoring
cardiac monitoring

Additional relevant MeSH terms:
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Ischemia
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases