Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center
Primary Purpose
Acute Coronary Syndrome, Cardiac Rehabilitation, Telerehabilitation
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cardiac Rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Coronary Syndrome focused on measuring Cardiac Rehabilitation, Telerehabilitation, Secondary Prevention, Wearable Electronic Devices, Exercise Therapy
Eligibility 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
Sites / Locations
- Hospital Universitario 12 de OctubreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
PEP-H
PEP-PSC
Arm Description
Physical exercise program at a hospital
Physical exercise program with tele-monitoring in a public sport centre
Outcomes
Primary Outcome Measures
Adherence to physical exercise
Adherence to physical exercise measured by number of physical exercise sessions realized by each patient
Functional capacity
Change of functional capacity measured by cardiopulmonary exercise test
Secondary Outcome Measures
Glucose levels
Evaluate changes on the glucose metabolic profile (mg/dL)
Glycated hemoglobin levels (HbA1c)
Evaluate changes on the glycated hemoglobin (mg/dL)
Low-density lipoprotein (LDL) levels
Evaluate changes on the LDL metabolic profile (mg/dL)
High-density lipoprotein (HDL) levels
Evaluate changes on the HDL metabolic profile (mg/dL)
Total colesterol levels
Evaluate changes on the total colesterol metabolic profile (mg/dL)
Blood pressure levels
Evaluate changes on systolic and diastolic blood pressure levels (mmHg)
Smoking
Evaluate changes on smoking status (cessation of smoking)
Weight
Evaluate changes on weight (kg)
Abdominal perimeter
Evaluate changes on abdominal perimeter (cm)
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)
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.
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'
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04121702
Brief Title
Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center
Official Title
Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center Versus Traditional Hospital Model
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan Izquierdo García
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Cardiac Rehabilitation, Telerehabilitation, Secondary Prevention, Wearable Electronic Devices, Exercise Therapy
Keywords
Cardiac Rehabilitation, Telerehabilitation, Secondary Prevention, Wearable Electronic Devices, Exercise Therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEP-H
Arm Type
Active Comparator
Arm Description
Physical exercise program at a hospital
Arm Title
PEP-PSC
Arm Type
Experimental
Arm Description
Physical exercise program with tele-monitoring in a public sport centre
Intervention Type
Procedure
Intervention Name(s)
Cardiac Rehabilitation
Intervention Description
Implementation of a physical exercise program (PEP) with tele-monitoring
Primary Outcome Measure Information:
Title
Adherence to physical exercise
Description
Adherence to physical exercise measured by number of physical exercise sessions realized by each patient
Time Frame
At the end of the program (6 weeks)
Title
Functional capacity
Description
Change of functional capacity measured by cardiopulmonary exercise test
Time Frame
At the end of the program (6 weeks)
Secondary Outcome Measure Information:
Title
Glucose levels
Description
Evaluate changes on the glucose metabolic profile (mg/dL)
Time Frame
At the end of the program (6 weeks)
Title
Glycated hemoglobin levels (HbA1c)
Description
Evaluate changes on the glycated hemoglobin (mg/dL)
Time Frame
At the end of the program (6 weeks)
Title
Low-density lipoprotein (LDL) levels
Description
Evaluate changes on the LDL metabolic profile (mg/dL)
Time Frame
At the end of the program (6 weeks)
Title
High-density lipoprotein (HDL) levels
Description
Evaluate changes on the HDL metabolic profile (mg/dL)
Time Frame
At the end of the program (6 weeks)
Title
Total colesterol levels
Description
Evaluate changes on the total colesterol metabolic profile (mg/dL)
Time Frame
At the end of the program (6 weeks)
Title
Blood pressure levels
Description
Evaluate changes on systolic and diastolic blood pressure levels (mmHg)
Time Frame
At the end of the program (6 weeks)
Title
Smoking
Description
Evaluate changes on smoking status (cessation of smoking)
Time Frame
At the end of the program (6 weeks)
Title
Weight
Description
Evaluate changes on weight (kg)
Time Frame
At the end of the program (6 weeks)
Title
Abdominal perimeter
Description
Evaluate changes on abdominal perimeter (cm)
Time Frame
At the end of the program (6 weeks)
Title
Body Mass Index (BMI)
Description
Evaluate changes on body mass index (weight in kg and height in meters will be combined to calculate BMI in kg/m˄2)
Time Frame
At the end of the program (6 weeks)
Title
Adherence to Mediterranean Diet
Description
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.
Time Frame
At the end of the program (6 weeks)
Title
Phisical exercise profile
Description
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'
Time Frame
At the end of the program (6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Izquierdo Garcia, Therapist
Phone
+34917792077
Email
juan.izquierdo@salud.madrid.org
First Name & Middle Initial & Last Name or Official Title & Degree
Guillermo Moreno Muñoz, Nurse
Phone
+34913908519
Email
guimoren@ucm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Izquierdo Garcia, Therapist
Organizational Affiliation
Hospital Universitario 12 de Octubre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Izquierdo Garcia, Therapist
Phone
+34917792077
Email
juan.izquierdo@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Guillermo Moreno Muñoz, Nurse
Phone
+34913908519
Email
guimoren@ucm.es
12. IPD Sharing Statement
Plan to Share IPD
No
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Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center
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