Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention and Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy

Conditions
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Angina, Unstable, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), ST-segment Elevation Myocardial Infarction (STEMI)

Intervention / Treatment
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* Device: telemonitoring
* Other: Centre-based cardiac rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac tele-rehabilitation<br>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. | Device: telemonitoring<br>* 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<br>|
| Active Comparator: Centre-based cardiac rehabilitation<br>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. | Other: Centre-based cardiac rehabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen uptake | Maximal oxygen uptake during the final 30 seconds of the cardiopulmonary exercise testing (CPET) (ml/kg/min ) | 10 months | 
| Maximal heart rate | Maximal heart rate at the end of the exercise testing (bpm) | 10 months | 
| Exercise time | stress test duration (minutes) | 10 months | 
| 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 | 10 months | 
| Glycosylated haemoglobin | Percentage | 10 months | 
| Weight | Kg | 4 and 10 months | 
| Waist circumference | waist circumference change (cm) | 4 and 10 months | 
| Visceral fat | Percentage | 4 and 10 months | 
| energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire | Kcal/week | 10 months | 
| High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire | Percentage | 10 months | 
| 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. | 10 months | 
| 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. | 10 months | 
| 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. | 10 months | 
| 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. | 10 months | 
| 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. | 10 months | 
| 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. | 10 months | 
| 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. | 10 months | 
| smoking cessation | percentage | 10 months | 
| Time to start the rehabilitation programme after discharge from hospital | days | 10 months | 
| Returning to work | days | 10 months | 
| Pulse wave velocity | m/s | 10 months | 
| User's experience from the System Usability Scale (SUS) score | Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome. | 10 months | 
| Cost-effectiveness analysis | net cost divided by changes in health outcomes | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile health, monitoring, cardiac rehabilitation, telerehabilitation, secondary prevention