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Homebased Monitoring Cardiac Rehabilitation Program (NUUBO)

Primary Purpose

Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Homebased cardiac rehabilitation program
Traditional cardiac rehabilitation program
Sponsored by
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease focused on measuring home monitoring, cardiac monitoring

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital MediterráneoRecruiting
  • Hospital Reina SofíaRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Homebased cardiac rehabilitation program

Traditional cardiac rehabilitation

Arm Description

Homebased Cardiac rehabilitation program with monitoring vest and mixed surveillance.

Multidisciplinary program in a cardiac rehabilitation gym. Routine clinical practice

Outcomes

Primary Outcome Measures

Effectiveness measured by exercise testing and control of cardiovascular risk factors
functional capacity obtained by exercise testing and control of cardiovascular risk factors.

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
May 23, 2016
Last Updated
June 6, 2016
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT02796404
Brief Title
Homebased Monitoring Cardiac Rehabilitation Program
Acronym
NUUBO
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease
Keywords
home monitoring, cardiac monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Homebased cardiac rehabilitation program
Arm Type
Experimental
Arm Description
Homebased Cardiac rehabilitation program with monitoring vest and mixed surveillance.
Arm Title
Traditional cardiac rehabilitation
Arm Type
Other
Arm Description
Multidisciplinary program in a cardiac rehabilitation gym. Routine clinical practice
Intervention Type
Device
Intervention Name(s)
Homebased cardiac rehabilitation program
Intervention Description
homebased cardiac rehabilitation program with monitoring vest Nuubo
Intervention Type
Other
Intervention Name(s)
Traditional cardiac rehabilitation program
Intervention Description
multidisciplinary intervention in cardiac rehabilitation gym
Primary Outcome Measure Information:
Title
Effectiveness measured by exercise testing and control of cardiovascular risk factors
Description
functional capacity obtained by exercise testing and control of cardiovascular risk factors.
Time Frame
During 12 months
Secondary Outcome Measure Information:
Title
Results of homebased cardiac rehabilitation monitoring a traditional cardiac rehabilitation program
Description
comparing the results of functional capacity measured by exercise testing and control of cardiovascular risk factors between the two groups
Time Frame
During 12 months
Title
Adherence to these programs
Description
see adherence to these program at 3, 6 months and a year depending on the habit of exercise and control of cardiovascular risk factors.
Time Frame
3, 6 and 12 months
Title
Safety to these program
Description
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.
Time Frame
During 12 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raquel Bravo, MD
Phone
34951291977
Email
rbravoescobar@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel Bravo, MD
Organizational Affiliation
rbravoescobar@yahoo.es
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Mediterráneo
City
Almería
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Francisco Chiquero, MD
First Name & Middle Initial & Last Name & Degree
Jose Francisco Chiquero, MD
First Name & Middle Initial & Last Name & Degree
Jose Ramon Vicente, MD
First Name & Middle Initial & Last Name & Degree
Carlos Gómez, MD
First Name & Middle Initial & Last Name & Degree
Beatriz Vargas
First Name & Middle Initial & Last Name & Degree
Cristina Vicario
First Name & Middle Initial & Last Name & Degree
Ines Maillo
Facility Name
Hospital Reina Sofía
City
Córdoba
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Heredia, MD
First Name & Middle Initial & Last Name & Degree
Angela Heredia, MD
First Name & Middle Initial & Last Name & Degree
José López, MD
First Name & Middle Initial & Last Name & Degree
Pilar Cano, MD
First Name & Middle Initial & Last Name & Degree
Milagros Ramos
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gloria Luque, MD
Phone
34951291977
Email
gloria.luque@fimabis.org
First Name & Middle Initial & Last Name & Degree
Adela Gómez, MD
First Name & Middle Initial & Last Name & Degree
Angel Montiel, MD
First Name & Middle Initial & Last Name & Degree
Rafael Aguilar
First Name & Middle Initial & Last Name & Degree
Rosa Carrasco
First Name & Middle Initial & Last Name & Degree
Raquel Bravo, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33580174
Citation
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.
Results Reference
derived
PubMed Identifier
28219338
Citation
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.
Results Reference
derived

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Homebased Monitoring Cardiac Rehabilitation Program

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