Homebased Cardiac Rehabilitation Program After Ischemic Heart DiseaseNUUBONCT02796404
Homebased Monitoring Cardiac Rehabilitation Program
A study testing Homebased cardiac rehabilitation program and Traditional cardiac rehabilitation program in people with Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease
- What is being tested?
- Homebased cardiac rehabilitation program and Traditional cardiac rehabilitation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesSpain
- Study dates
- Aug 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Mediterráneo
Almería, Almería
Jose Francisco Chiquero, MD
Jose Francisco Chiquero, MD
- Recruiting
Hospital Reina Sofía
Córdoba, Córdoba
Angela Heredia, MD
Angela Heredia, MD
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, 29010
Gloria Luque, MD, 34951291977, gloria.luque@fimabis.org
Adela Gómez, MD
About this study
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
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.
Read the 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.
- Being tested
- Homebased cardiac rehabilitation program, Traditional cardiac rehabilitation program
- Keywords
- home monitoring, cardiac monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homebased cardiac rehabilitation programDevice
homebased cardiac rehabilitation program with monitoring vest Nuubo
Traditional cardiac rehabilitation programOther
multidisciplinary intervention in cardiac rehabilitation gym
| Study group | Role | What they receive |
|---|---|---|
| Homebased cardiac rehabilitation program | Experimental | Homebased Cardiac rehabilitation program with monitoring vest and mixed surveillance. Receives: Device: Homebased cardiac rehabilitation program; Other: Traditional cardiac rehabilitation program |
| Traditional cardiac rehabilitation | Other | Multidisciplinary program in a cardiac rehabilitation gym. Routine clinical practice Receives: Other: Traditional cardiac rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness measured by exercise testing and control of cardiovascular risk factors
functional capacity obtained by exercise testing and control of cardiovascular risk factors.
Measured: During 12 months
Secondary outcomes (3)
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
Measured: During 12 months
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.
Measured: 3, 6 and 12 months
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.
Measured: During 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Homebased Cardiac Rehabilitation Program After Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raquel Bravo, MD, Principal investigator, rbravoescobar@yahoo.es
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796404
- Sponsor's protocol ID
- NUUBO
- Acronym
- NUUBO
- Status last verified
- May 2016
- First submitted
- 23 May 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37593110Bravo-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.
PubMed 33580174Bravo-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.
PubMed 28219338
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02796404
- Acronym / sponsor ID
- NUUBO / NUUBO
- Keywords
- home monitoring, cardiac monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homebased cardiac rehabilitation program | Experimental | Device: Homebased cardiac rehabilitation program, Other: Traditional cardiac rehabilitation programHomebased Cardiac rehabilitation program with monitoring vest and mixed surveillance. |
| Traditional cardiac rehabilitation | Other | Other: Traditional cardiac rehabilitation programMultidisciplinary program in a cardiac rehabilitation gym. Routine clinical practice |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homebased cardiac rehabilitation programhomebased cardiac rehabilitation program with monitoring vest Nuubo | Device | Homebased cardiac rehabilitation program |
| Traditional cardiac rehabilitation programmultidisciplinary intervention in cardiac rehabilitation gym | Other | Homebased cardiac rehabilitation program, Traditional cardiac rehabilitation |
Primary outcome
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.
3 secondary outcomes
Results of homebased cardiac rehabilitation monitoring a traditional cardiac rehabilitation program
Time frame: During 12 months
Adherence to these programs
Time frame: 3, 6 and 12 months
Safety to these program
Time frame: During 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Derived from this study: PubMed 37593110Yang 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.
- Derived from this study: PubMed 33580174Bravo-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.
- Derived from this study: PubMed 28219338Bravo-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel Bravo, MD principal investigator
rbravoescobar@yahoo.es
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homebased cardiac rehabilitation program and Traditional cardiac rehabilitation program in people with Homebased Cardiac Rehabilitation Program After Ischemic Heart Disease, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raquel Bravo, MD (34951291977, rbravoescobar@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness measured by exercise testing and control of cardiovascular risk factors (time frame: During 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02796404, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.