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Homebased Monitoring Cardiac Rehabilitation Program (NUUBO)

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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

Tracking Information
First Submitted Date  ICMJE May 23, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date June 10, 2016
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Homebased Monitoring Cardiac Rehabilitation Program
Official Title  ICMJE Effectiveness of a Homebased Cardiac Rehabilitation Program of Mixed Surveillance Using NUUBO Monitoring Vest in Patients With Ischemic Heart Disease at Moderate Cardiovascular Risk
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease
Intervention  ICMJE
  • Device: Homebased cardiac rehabilitation program
    homebased cardiac rehabilitation program with monitoring vest Nuubo
  • Other: Traditional cardiac rehabilitation program
    multidisciplinary intervention in cardiac rehabilitation gym
Study Arms  ICMJE
  • Experimental: Homebased cardiac rehabilitation program
    Homebased Cardiac rehabilitation program with monitoring vest and mixed surveillance.
    Interventions:
    • Device: Homebased cardiac rehabilitation program
    • Other: Traditional cardiac rehabilitation program
  • Traditional cardiac rehabilitation
    Multidisciplinary program in a cardiac rehabilitation gym. Routine clinical practice
    Intervention: Other: Traditional cardiac rehabilitation program
Publications * Bravo-Escobar R, González-Represas A, Gómez-González AM, Montiel-Trujillo A, Aguilar-Jimenez R, Carrasco-Ruíz R, Salinas-Sánchez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
148
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796404
Other Study ID Numbers  ICMJE NUUBO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study Sponsor  ICMJE Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raquel Bravo, MD rbravoescobar@yahoo.es
PRS Account Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP