Back to resultsRehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
Primary Purpose
Angina, Unstable, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), ST-segment Elevation Myocardial Infarction (STEMI)
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
telemonitoring
Centre-based cardiac rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Angina, Unstable focused on measuring mobile health, monitoring, cardiac rehabilitation, telerehabilitation, secondary prevention
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent
- Patients after uncomplicated acute coronary syndrome of both sexes.
- Patients completing a maximal or symptom-limited CPET without angina or electrical ischaemia.
- Age equal to or less than 72 years.
Exclusion Criteria:
- Refusal of informed consent
- Advanced biological age.
- Kidney failure (GFR < 30ml/min/1.73 m2).
- Liver failure (GOT >2 times normal value).
- Ejection fraction less than 50%.
- Uncontrolled blood pressure (>140/90 mmHg).
- Uncontrolled heart failure.
- Dissecting aortic aneurysm.
- Uncontrolled ventricular tachycardia or other dangerous ventricular arrhythmias.
- Aortic or mitral valve disease.
- Recent systemic or pulmonary embolism.
- Active or recent thrombophlebitis.
- Acute infectious diseases.
- Uncontrolled supraventricular arrhythmias or tachycardia.
- Repeated or frequent ventricular ectopic activity.
- Moderate pulmonary hypertension.
- Ventricular aneurysm.
- Uncontrolled diabetes, thyrotoxicosis, myxedema,
- Conduction disorders such as: complete atrioventricular block. Left bundle branch block.
- Wolf-Parkinson-White syndrome.
- Fixed rate pacing.
- Severe anaemia.
- Psychoneurotic disorders.
- Neuromuscular, musculoskeletal and arthritic disorders that may limit activity. may limit activity.
Sites / Locations
- Ernesto Dalli Peydró
- Hospital Politécnico Universitario La Fe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cardiac tele-rehabilitation
Centre-based cardiac rehabilitation
Arm Description
Patients in the Intervention Group will come to the hospital 4 times during two consecutive weeks, undergoing physical exercise sessions and the same educational talks as in the control group. Subsequently, they will follow the scheduled physical activities and adherence to the risk factor management according to individualised guidelines in their App, until the end of the study period. All data generated are recorded on the professional website. The degree of compliance with the objectives set is monitored by means of 7 coloured icons, which vary according to the target achievement.
Patients in the control group will come to the hospital 16 times during eight weeks for cycling and muscle strengthening exercises. Educational talks will be given. At the end of the hospital phase, a conventional outpatient follow-up by primary care and the corresponding specialist will be carried out.
Outcomes
Primary Outcome Measures
Physical activity derived from the International Physical Activity questionnaire (IPAQ)
self-reported physical activity measured in metabolic equivalents (MET-min/week) Minimum value: 0, maximum value 19,278. Higher scores mean a better outcome.
Secondary Outcome Measures
Maximal oxygen uptake
Maximal oxygen uptake during the final 30 seconds of the cardiopulmonary exercise testing (CPET) (ml/kg/min )
Maximal heart rate
Maximal heart rate at the end of the exercise testing (bpm)
Exercise time
stress test duration (minutes)
Lipid parameters
Total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), Non-HDL cholesterol (mg/dL), Triglycerides (mg/dL), Apolipoprotein B/Apolipoprotein A-I ratio
Glycosylated haemoglobin
Percentage
Weight
Kg
Waist circumference
waist circumference change (cm)
Visceral fat
Percentage
energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire
Kcal/week
High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire
Percentage
Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED).
Units. Minimum value: 0, maximum value: 14. Higher scores mean a better outcome.
High level of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED)
percentage. Minimum value: 0%, maximum value: 100%. Higher scores mean a better outcome.
Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
Units. Minimum value: 0, maximum value: 14. Lower scores mean a better outcome.
Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D)
Units. Minimum value: 0, maximum value: 1. Higher scores mean a better outcome.
Health status obtained from the European Quality of Life questionnaire (EuroQol-5D)
Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
smoking cessation
percentage
Time to start the rehabilitation programme after discharge from hospital
days
Returning to work
days
Pulse wave velocity
m/s
User's experience from the System Usability Scale (SUS) score
Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
Cost-effectiveness analysis
net cost divided by changes in health outcomes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04942977
Brief Title
Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
Official Title
Prevention and Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catcronic Salut SL
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
Cardiac rehabilitation after an acute coronary syndrome is recognised in the latest guidelines and recommendations published by the major scientific societies as a class I indication. Despite this evidence, the number of patients entering such programmes in Europe is still around 30%. The present study aims to validate a new comprehensive Telerehabilitation System to provide support for cardiac rehabilitation, to optimize it and to test its usefulness in terms of improving adherence to physical exercise and cardiovascular risk parameters.
Detailed Description
To validate this approach, a clinical trial was designed to compare a 10-month program of cardiac telerehabilitation with a conventional 8-week centre-based cardiac rehabilitation. Seventy patients will be randomized 1:1 to cardiac telemonitoring or centre-based cardiac rehabilitation. The characteristics of the interventions do not allow the study to be blinded to the patient or the professional. However, the analyses, stress tests and questionaires will be carried out in a masked form without the assigned group being identified by the researchers carrying out the examinations. Assessment for primary and main secondary outcomes will be performed at baseline and at ten months of follow-up, and will include self-reported physical activity (IPAQ), VO2max, blood test, general emotional distress, Adherence to the Mediterranean Diet, quality of life, vital signs, returning to work. The hypothesis is that patients randomised to prolonged telemonitoring will demonstrate higher levels of physical activity at 10-month follow-up, compared to patients in the centre-based cardiac rehabilitation programme, as well other positive changes in the cardiovascular risk profile.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina, Unstable, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), ST-segment Elevation Myocardial Infarction (STEMI)
Keywords
mobile health, monitoring, cardiac rehabilitation, telerehabilitation, secondary prevention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Phase III clinical trial, feasibility, controlled and randomized, with two arms: cardiac telerehabilitation (intervention group) and centre-based cardiac rehabilitation (control group)
Masking
Care Provider
Masking Description
The characteristics of the interventions do not allow the study to be blinded either for the patient or for the professional. However, the analyses, stress tests and shuttle tests will be performed in a masked manner without the assigned group being identified by the investigators who carry out the examinations.
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac tele-rehabilitation
Arm Type
Experimental
Arm Description
Patients in the Intervention Group will come to the hospital 4 times during two consecutive weeks, undergoing physical exercise sessions and the same educational talks as in the control group. Subsequently, they will follow the scheduled physical activities and adherence to the risk factor management according to individualised guidelines in their App, until the end of the study period. All data generated are recorded on the professional website. The degree of compliance with the objectives set is monitored by means of 7 coloured icons, which vary according to the target achievement.
Arm Title
Centre-based cardiac rehabilitation
Arm Type
Active Comparator
Arm Description
Patients in the control group will come to the hospital 16 times during eight weeks for cycling and muscle strengthening exercises. Educational talks will be given. At the end of the hospital phase, a conventional outpatient follow-up by primary care and the corresponding specialist will be carried out.
Intervention Type
Device
Intervention Name(s)
telemonitoring
Intervention Description
The system consists of the following elements:
Professional website at the hospital, which allows:
To set up an individualised care plan
To establish the patient's risk profile and targets for improvement.
Long-term monitoring of the evolution of cardiovascular risk factors and events that occurred
Advise the patient on self-management strategies.
Mobile application software with the following functions:
Scheduled exercise sessions
Medication reminder
Measurement reminder (weight, blood pressure, heart rate, waist circumference, etc.)
Messages: Inbox folder for system messages and messages generated by professionals for a specific patient or video conference.
Training monitor: guides the patient in the performance of their exercise.
Access to certified health information for patients
Intervention Type
Other
Intervention Name(s)
Centre-based cardiac rehabilitation
Intervention Description
The physical activity consisted of a workout routine and aerobic cycling training. Patients are instructed to perform 150 minutes per week of moderate physical activity when the hospital phase finishes.
Primary Outcome Measure Information:
Title
Physical activity derived from the International Physical Activity questionnaire (IPAQ)
Description
self-reported physical activity measured in metabolic equivalents (MET-min/week) Minimum value: 0, maximum value 19,278. Higher scores mean a better outcome.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Maximal oxygen uptake
Description
Maximal oxygen uptake during the final 30 seconds of the cardiopulmonary exercise testing (CPET) (ml/kg/min )
Time Frame
10 months
Title
Maximal heart rate
Description
Maximal heart rate at the end of the exercise testing (bpm)
Time Frame
10 months
Title
Exercise time
Description
stress test duration (minutes)
Time Frame
10 months
Title
Lipid parameters
Description
Total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), Non-HDL cholesterol (mg/dL), Triglycerides (mg/dL), Apolipoprotein B/Apolipoprotein A-I ratio
Time Frame
10 months
Title
Glycosylated haemoglobin
Description
Percentage
Time Frame
10 months
Title
Weight
Description
Kg
Time Frame
4 and 10 months
Title
Waist circumference
Description
waist circumference change (cm)
Time Frame
4 and 10 months
Title
Visceral fat
Description
Percentage
Time Frame
4 and 10 months
Title
energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire
Description
Kcal/week
Time Frame
10 months
Title
High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire
Description
Percentage
Time Frame
10 months
Title
Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED).
Description
Units. Minimum value: 0, maximum value: 14. Higher scores mean a better outcome.
Time Frame
10 months
Title
High level of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED)
Description
percentage. Minimum value: 0%, maximum value: 100%. Higher scores mean a better outcome.
Time Frame
10 months
Title
Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
Description
Units. Minimum value: 0, maximum value: 14. Lower scores mean a better outcome.
Time Frame
10 months
Title
Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
Description
Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
Time Frame
10 months
Title
Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
Description
Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
Time Frame
10 months
Title
Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D)
Description
Units. Minimum value: 0, maximum value: 1. Higher scores mean a better outcome.
Time Frame
10 months
Title
Health status obtained from the European Quality of Life questionnaire (EuroQol-5D)
Description
Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
Time Frame
10 months
Title
smoking cessation
Description
percentage
Time Frame
10 months
Title
Time to start the rehabilitation programme after discharge from hospital
Description
days
Time Frame
10 months
Title
Returning to work
Description
days
Time Frame
10 months
Title
Pulse wave velocity
Description
m/s
Time Frame
10 months
Title
User's experience from the System Usability Scale (SUS) score
Description
Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
Time Frame
10 months
Title
Cost-effectiveness analysis
Description
net cost divided by changes in health outcomes
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent
Patients after uncomplicated acute coronary syndrome of both sexes.
Patients completing a maximal or symptom-limited CPET without angina or electrical ischaemia.
Age equal to or less than 72 years.
Exclusion Criteria:
Refusal of informed consent
Advanced biological age.
Kidney failure (GFR < 30ml/min/1.73 m2).
Liver failure (GOT >2 times normal value).
Ejection fraction less than 50%.
Uncontrolled blood pressure (>140/90 mmHg).
Uncontrolled heart failure.
Dissecting aortic aneurysm.
Uncontrolled ventricular tachycardia or other dangerous ventricular arrhythmias.
Aortic or mitral valve disease.
Recent systemic or pulmonary embolism.
Active or recent thrombophlebitis.
Acute infectious diseases.
Uncontrolled supraventricular arrhythmias or tachycardia.
Repeated or frequent ventricular ectopic activity.
Moderate pulmonary hypertension.
Ventricular aneurysm.
Uncontrolled diabetes, thyrotoxicosis, myxedema,
Conduction disorders such as: complete atrioventricular block. Left bundle branch block.
Wolf-Parkinson-White syndrome.
Fixed rate pacing.
Severe anaemia.
Psychoneurotic disorders.
Neuromuscular, musculoskeletal and arthritic disorders that may limit activity. may limit activity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernesto Dalli Peydró, MD
Organizational Affiliation
Hospital Arnau de Vilanova. Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ernesto Dalli Peydró
City
Valencia
ZIP/Postal Code
46008
Country
Spain
Facility Name
Hospital Politécnico Universitario La Fe
City
Valencia
ZIP/Postal Code
46008
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33611446
Citation
Ambrosetti M, Abreu A, Corra U, Davos CH, Hansen D, Frederix I, Iliou MC, Pedretti RFE, Schmid JP, Vigorito C, Voller H, Wilhelm M, Piepoli MF, Bjarnason-Wehrens B, Berger T, Cohen-Solal A, Cornelissen V, Dendale P, Doehner W, Gaita D, Gevaert AB, Kemps H, Kraenkel N, Laukkanen J, Mendes M, Niebauer J, Simonenko M, Zwisler AO. Secondary prevention through comprehensive cardiovascular rehabilitation: From knowledge to implementation. 2020 update. A position paper from the Secondary Prevention and Rehabilitation Section of the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2021 May 14;28(5):460-495. doi: 10.1177/2047487320913379.
Results Reference
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PubMed Identifier
31082266
Citation
Thomas RJ, Beatty AL, Beckie TM, Brewer LC, Brown TM, Forman DE, Franklin BA, Keteyian SJ, Kitzman DW, Regensteiner JG, Sanderson BK, Whooley MA. Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology. Circulation. 2019 Jul 2;140(1):e69-e89. doi: 10.1161/CIR.0000000000000663. Epub 2019 May 13.
Results Reference
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PubMed Identifier
25475219
Citation
Frederix I, Vanhees L, Dendale P, Goetschalckx K. A review of telerehabilitation for cardiac patients. J Telemed Telecare. 2015 Jan;21(1):45-53. doi: 10.1177/1357633X14562732. Epub 2014 Dec 4.
Results Reference
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PubMed Identifier
33623986
Citation
Scherrenberg M, Falter M, Dendale P. Providing comprehensive cardiac rehabilitation during and after the COVID-19 pandemic. Eur J Prev Cardiol. 2021 May 14;28(5):520-521. doi: 10.1093/eurjpc/zwaa107. No abstract available.
Results Reference
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PubMed Identifier
30971111
Citation
Reibis R, Salzwedel A, Abreu A, Corra U, Davos C, Doehner W, Doherty P, Frederix I, Hansen D, Christine Iliou M, Vigorito C, Voller H; Secondary Prevention and Rehabilitation of the European Association of Preventive Cardiology (EAPC). The importance of return to work: How to achieve optimal reintegration in ACS patients. Eur J Prev Cardiol. 2019 Sep;26(13):1358-1369. doi: 10.1177/2047487319839263. Epub 2019 Apr 10.
Results Reference
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Citation
Frederix I, Hansen D, Coninx K, Vandervoort P, Vandijck D, Hens N, Van Craenenbroeck E, Van Driessche N, Dendale P. Medium-Term Effectiveness of a Comprehensive Internet-Based and Patient-Specific Telerehabilitation Program With Text Messaging Support for Cardiac Patients: Randomized Controlled Trial. J Med Internet Res. 2015 Jul 23;17(7):e185. doi: 10.2196/jmir.4799.
Results Reference
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Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
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