Acute Coronary SyndromeNCT04121702
Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center
A study testing Cardiac Rehabilitation in people with Acute Coronary Syndrome and Cardiac Rehabilitation, run by Juan Izquierdo García at 1 site in Spain.
Trial summary
The aim of this study is to establish an innovative Cardiac Tele-Rehabilitation (CTR) model. It could expands assistance resources through coordination with public administrations, developing a physical exercise program (PEP) assistance model in phase II that resolves the current situation of lack of adherence in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Cardiac Rehabilitation, Telerehabilitation
- What is being tested?
- Cardiac Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 8 May 2019to Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent ACS (1-12 months) of low / moderate risk for the realization of a PEP and without physical impediments for it
- Availability of a mobile phone with Android operating system where you can install the S-PATCH3-Cardio application
- Patients who recognize that they are trained to operate the S-PATCH3-Cardio device after being instructed in its operation and perform a 24-hour simulation.
- Signature of informed consent
Who cannot join
- Baseline ergospirometry that does not reach maximalist criteria (respiratory quotient> 1.1)
- Mental disability
- Associated comorbidity that prevents performing PEP
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Juan Izquierdo Garcia, Therapist, +34917792077, juan.izquierdo@salud.madrid.org
Guillermo Moreno Muñoz, Nurse, +34913908519, guimoren@ucm.es
About this study
Official title: Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center Versus Traditional Hospital Model
The aim of this study is to establish an innovative Cardiac Tele-Rehabilitation (CTR) model. It could expands assistance resources through coordination with public administrations, developing a physical exercise program (PEP) assistance model in phase II that resolves the current situation of lack of adherence in the PEP due in part to the long waiting time to start it. To sum up this study could improve adherence in Cardiac Rehabilitation Phase III. It represents an opportunity to validate an innovative model for the realization of the PEP for phase II that could be expanded to other centres.
Read the detailed description
Cardiac Rehabilitation (CR) programs show benefits in cardiovascular morbidity and mortality, exercise capacity, risk factors and quality of life. The use of new information and communication technologies (ICT) allows remote monitoring of activity and rhythm, defining a new model of cardiac tele-rehabilitation (CTR) and proving to be safe.
The investigators intend to evaluate a new model of CR in Phase II in acute coronary syndrome (ACS), based on the implementation of the physical exercise program (PEP) in a public sports centre (PSC) with tele-monitoring by means of a wearable electronic device, S-PATCH3-Cardio, to compare the adherence of a PEP based on a CTR-PSC model with the traditional in-hospital program (PEP-H) maintaining the efficacy and safety of the CR program.
Patients with recent stratified ACS of low and / or moderate risk will be included who will be randomly assigned to the PEP-H group who will perform 18 PEP sessions with strength training and cardiorespiratory resistance in a hospital, or a CTR-PSC group that performs the 18 sessions of the PEP with strength training and cardiorespiratory resistance in the PSC.
All patients will perform the rest of the CR program at the hospital that it includes: functional tests, consultations with nurse, cardiologist, rehabilitation doctor, and the educational program, with 10 Workshops in a Cardio-healthy Classroom.
- Conditions
- Acute Coronary Syndrome, Cardiac Rehabilitation, Telerehabilitation, Secondary Prevention, Wearable Electronic Devices, Exercise Therapy
- Being tested
- Cardiac Rehabilitation
- Keywords
- Cardiac Rehabilitation, Telerehabilitation, Secondary Prevention, Wearable Electronic Devices, Exercise Therapy
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac RehabilitationProcedure or surgery
Implementation of a physical exercise program (PEP) with tele-monitoring
| Study group | Role | What they receive |
|---|---|---|
| PEP-H | Active comparator | Physical exercise program at a hospital Receives: Procedure: Cardiac Rehabilitation |
| PEP-PSC | Experimental | Physical exercise program with tele-monitoring in a public sport centre Receives: Procedure: Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to physical exercise
Adherence to physical exercise measured by number of physical exercise sessions realized by each patient
Measured: At the end of the program (6 weeks)
Functional capacity
Change of functional capacity measured by cardiopulmonary exercise test
Measured: At the end of the program (6 weeks)
Secondary outcomes (12)
Glucose levels
Evaluate changes on the glucose metabolic profile (mg/dL)
Measured: At the end of the program (6 weeks)
Glycated hemoglobin levels (HbA1c)
Evaluate changes on the glycated hemoglobin (mg/dL)
Measured: At the end of the program (6 weeks)
Low-density lipoprotein (LDL) levels
Evaluate changes on the LDL metabolic profile (mg/dL)
Measured: At the end of the program (6 weeks)
High-density lipoprotein (HDL) levels
Evaluate changes on the HDL metabolic profile (mg/dL)
Measured: At the end of the program (6 weeks)
Total colesterol levels
Evaluate changes on the total colesterol metabolic profile (mg/dL)
Measured: At the end of the program (6 weeks)
Blood pressure levels
Evaluate changes on systolic and diastolic blood pressure levels (mmHg)
Measured: At the end of the program (6 weeks)
Smoking
Evaluate changes on smoking status (cessation of smoking)
Measured: At the end of the program (6 weeks)
Weight
Evaluate changes on weight (kg)
Measured: At the end of the program (6 weeks)
Abdominal perimeter
Evaluate changes on abdominal perimeter (cm)
Measured: At the end of the program (6 weeks)
Body Mass Index (BMI)
Evaluate changes on body mass index (weight in kg and height in meters will be combined to calculate BMI in kg/m˄2)
Measured: At the end of the program (6 weeks)
Adherence to Mediterranean Diet
Evaluate changes on mediterranean dietary habits measured ussing the Mediterranean Diet Assessment Scale (MEDAS) which is constituted by 14 ítems with questions concerning dietary habits related to the medditerranean dietary style. Minimum score: 0, maximum score: 14. Values over 9 are corresponded to good adherence to mediterranean diet, values under 9 are considered to be bad adherence.
Measured: At the end of the program (6 weeks)
Phisical exercise profile
Evaluate changes on level of physical activity measured ussing the International Physical Activity Questionnaire (IPAQ). It asks about three specific types of activity undertaken in the four domains: leisure time physical activity, domestic and gardening (yard) activities, work-related physical activity, transport-related physical activity. The specific types of activity that are assessed are walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Maximun value: the sum total of all Walking, Moderate and Vigorous time variables greater than 960 minutes (16 hours).
Mínimum value: Only values of 10 or more minutes of activity should be included in the calculation of summary scores. Responses of less than 10 minutes [and their associated days] should be re-coded to 'zero'
Measured: At the end of the program (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start8 May 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Izquierdo García
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Izquierdo García, Hospital Universitario 12 de Octubre
- Investigators
- Juan Izquierdo Garcia, Therapist, Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121702
- Sponsor's protocol ID
- e-CARCEX
- Status last verified
- Oct 2019
- First submitted
- 17 Jun 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center Versus Traditional Hospital Model
- ClinicalTrials.gov ID
- NCT04121702
- Acronym / sponsor ID
- e-CARCEX
- Conditions
- Acute Coronary Syndrome, Cardiac Rehabilitation, Telerehabilitation, Secondary Prevention, Wearable Electronic Devices, Exercise Therapy
- Keywords
- Cardiac Rehabilitation, Telerehabilitation, Secondary Prevention, Wearable Electronic Devices, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Juan Izquierdo GarcíaUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Oct 2019 (actual)
- 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 aim of this study is to establish an innovative Cardiac Tele-Rehabilitation (CTR) model. It could expands assistance resources through coordination with public administrations, developing a physical exercise program (PEP) assistance model in phase II that resolves the current situation of lack of adherence in the PEP due in part to the long waiting time to start it. To sum up this study could improve adherence in Cardiac Rehabilitation Phase III. It represents an opportunity to validate an innovative model for the realization of the PEP for phase II that could be expanded to other centres.
Detailed description
Cardiac Rehabilitation (CR) programs show benefits in cardiovascular morbidity and mortality, exercise capacity, risk factors and quality of life. The use of new information and communication technologies (ICT) allows remote monitoring of activity and rhythm, defining a new model of cardiac tele-rehabilitation (CTR) and proving to be safe.
The investigators intend to evaluate a new model of CR in Phase II in acute coronary syndrome (ACS), based on the implementation of the physical exercise program (PEP) in a public sports centre (PSC) with tele-monitoring by means of a wearable electronic device, S-PATCH3-Cardio, to compare the adherence of a PEP based on a CTR-PSC model with the traditional in-hospital program (PEP-H) maintaining the efficacy and safety of the CR program.
Patients with recent stratified ACS of low and / or moderate risk will be included who will be randomly assigned to the PEP-H group who will perform 18 PEP sessions with strength training and cardiorespiratory resistance in a hospital, or a CTR-PSC group that performs the 18 sessions of the PEP with strength training and cardiorespiratory resistance in the PSC.
All patients will perform the rest of the CR program at the hospital that it includes: functional tests, consultations with nurse, cardiologist, rehabilitation doctor, and the educational program, with 10 Workshops in a Cardio-healthy Classroom.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEP-H | Active comparator | Procedure: Cardiac RehabilitationPhysical exercise program at a hospital |
| PEP-PSC | Experimental | Procedure: Cardiac RehabilitationPhysical exercise program with tele-monitoring in a public sport centre |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recent ACS (1-12 months) of low / moderate risk for the realization of a PEP and without physical impediments for it
- Availability of a mobile phone with Android operating system where you can install the S-PATCH3-Cardio application
- Patients who recognize that they are trained to operate the S-PATCH3-Cardio device after being instructed in its operation and perform a 24-hour simulation.
- Signature of informed consent
Key exclusion criteria (3 listed)
- Baseline ergospirometry that does not reach maximalist criteria (respiratory quotient> 1.1)
- Mental disability
- Associated comorbidity that prevents performing PEP
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 |
|---|---|---|
| Cardiac RehabilitationImplementation of a physical exercise program (PEP) with tele-monitoring | Procedure or surgery | PEP-H, PEP-PSC |
Primary outcome
Adherence to physical exercise
Time frame: At the end of the program (6 weeks)
Adherence to physical exercise measured by number of physical exercise sessions realized by each patient
Functional capacity
Time frame: At the end of the program (6 weeks)
Change of functional capacity measured by cardiopulmonary exercise test
12 secondary outcomes
Glucose levels
Time frame: At the end of the program (6 weeks)
Glycated hemoglobin levels (HbA1c)
Time frame: At the end of the program (6 weeks)
Low-density lipoprotein (LDL) levels
Time frame: At the end of the program (6 weeks)
High-density lipoprotein (HDL) levels
Time frame: At the end of the program (6 weeks)
Total colesterol levels
Time frame: At the end of the program (6 weeks)
Blood pressure levels
Time frame: At the end of the program (6 weeks)
Smoking
Time frame: At the end of the program (6 weeks)
Weight
Time frame: At the end of the program (6 weeks)
Abdominal perimeter
Time frame: At the end of the program (6 weeks)
Body Mass Index (BMI)
Time frame: At the end of the program (6 weeks)
Adherence to Mediterranean Diet
Time frame: At the end of the program (6 weeks)
Phisical exercise profile
Time frame: At the end of the program (6 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Juan Izquierdo Garcia, Therapist principal investigator
Hospital Universitario 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation in people with Acute Coronary Syndrome and Cardiac Rehabilitation, run by Juan Izquierdo García at 1 site 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 4 inclusion and 3 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 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Juan Izquierdo Garcia, Therapist (+34917792077, juan.izquierdo@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to physical exercise (time frame: At the end of the program (6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2019.