Homebased Monitoring Cardiac Rehabilitation Program (NUUBO)

June 6, 2016 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain
        • Recruiting
        • Hospital Mediterráneo
        • 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
      • Córdoba, Spain
        • Recruiting
        • Hospital Reina Sofia
        • Contact:
          • Angela Heredia, MD
        • Principal Investigator:
          • Angela Heredia, MD
        • Sub-Investigator:
          • José López, MD
        • Sub-Investigator:
          • Pilar Cano, MD
        • Sub-Investigator:
          • Milagros Ramos
      • Malaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
        • Sub-Investigator:
          • Adela Gómez, MD
        • Sub-Investigator:
          • Angel Montiel, MD
        • Sub-Investigator:
          • Rafael Aguilar
        • Sub-Investigator:
          • Rosa Carrasco
        • Principal Investigator:
          • Raquel Bravo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During 12 months
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, 6 and 12 months
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.
During 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Raquel Bravo, MD, rbravoescobar@yahoo.es

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Estimate)

June 10, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUUBO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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