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Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center

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ClinicalTrials.gov Identifier: NCT04121702
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Juan Izquierdo García, Hospital Universitario 12 de Octubre

Brief 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 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Cardiac Rehabilitation Telerehabilitation Secondary Prevention Wearable Electronic Devices Exercise Therapy Procedure: Cardiac Rehabilitation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center Versus Traditional Hospital Model
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PEP-H
Physical exercise program at a hospital
Procedure: Cardiac Rehabilitation
Implementation of a physical exercise program (PEP) with tele-monitoring

Experimental: PEP-PSC
Physical exercise program with tele-monitoring in a public sport centre
Procedure: Cardiac Rehabilitation
Implementation of a physical exercise program (PEP) with tele-monitoring




Primary Outcome Measures :
  1. 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

  2. Functional capacity [ Time Frame: At the end of the program (6 weeks) ]
    Change of functional capacity measured by cardiopulmonary exercise test


Secondary Outcome Measures :
  1. Glucose levels [ Time Frame: At the end of the program (6 weeks) ]
    Evaluate changes on the glucose metabolic profile (mg/dL)

  2. Glycated hemoglobin levels (HbA1c) [ Time Frame: At the end of the program (6 weeks) ]
    Evaluate changes on the glycated hemoglobin (mg/dL)

  3. Low-density lipoprotein (LDL) levels [ Time Frame: At the end of the program (6 weeks) ]
    Evaluate changes on the LDL metabolic profile (mg/dL)

  4. High-density lipoprotein (HDL) levels [ Time Frame: At the end of the program (6 weeks) ]
    Evaluate changes on the HDL metabolic profile (mg/dL)

  5. Total colesterol levels [ Time Frame: At the end of the program (6 weeks) ]
    Evaluate changes on the total colesterol metabolic profile (mg/dL)

  6. Blood pressure levels [ Time Frame: At the end of the program (6 weeks) ]
    Evaluate changes on systolic and diastolic blood pressure levels (mmHg)

  7. Smoking [ Time Frame: At the end of the program (6 weeks) ]
    Evaluate changes on smoking status (cessation of smoking)

  8. Weight [ Time Frame: At the end of the program (6 weeks) ]
    Evaluate changes on weight (kg)

  9. Abdominal perimeter [ Time Frame: At the end of the program (6 weeks) ]
    Evaluate changes on abdominal perimeter (cm)

  10. Body Mass Index (BMI) [ Time Frame: At the end of the program (6 weeks) ]
    Evaluate changes on body mass index (weight in kg and height in meters will be combined to calculate BMI in kg/m˄2)

  11. Adherence to Mediterranean Diet [ Time Frame: At the end of the program (6 weeks) ]
    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.

  12. Phisical exercise profile [ Time Frame: At the end of the program (6 weeks) ]

    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'




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Baseline ergospirometry that does not reach maximalist criteria (respiratory quotient> 1.1)
  • Mental disability
  • Associated comorbidity that prevents performing PEP

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121702


Contacts
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Contact: Juan Izquierdo Garcia, Therapist +34917792077 juan.izquierdo@salud.madrid.org
Contact: Guillermo Moreno Muñoz, Nurse +34913908519 guimoren@ucm.es

Locations
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Spain
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Juan Izquierdo Garcia, Therapist    +34917792077    juan.izquierdo@salud.madrid.org   
Contact: Guillermo Moreno Muñoz, Nurse    +34913908519    guimoren@ucm.es   
Sponsors and Collaborators
Juan Izquierdo García
Investigators
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Principal Investigator: Juan Izquierdo Garcia, Therapist Hospital Universitario 12 de Octubre

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Responsible Party: Juan Izquierdo García, Juan Izquierdo García, Physical Therapist, Principal Investigator, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT04121702     History of Changes
Other Study ID Numbers: e-CARCEX
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan Izquierdo García, Hospital Universitario 12 de Octubre:
Cardiac Rehabilitation
Telerehabilitation
Secondary Prevention
Wearable Electronic Devices
Exercise Therapy
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases