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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
67
The system consists of the following elements: 1. 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. 2. 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
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.
Ernesto Dalli Peydró
Valencia, Spain
Hospital Politécnico Universitario La Fe
Valencia, Spain
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.
Time frame: 10 months
Maximal oxygen uptake
Maximal oxygen uptake during the final 30 seconds of the cardiopulmonary exercise testing (CPET) (ml/kg/min )
Time frame: 10 months
Maximal heart rate
Maximal heart rate at the end of the exercise testing (bpm)
Time frame: 10 months
Exercise time
stress test duration (minutes)
Time frame: 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
Time frame: 10 months
Glycosylated haemoglobin
Percentage
Time frame: 10 months
Weight
Kg
Time frame: 4 and 10 months
Waist circumference
waist circumference change (cm)
Time frame: 4 and 10 months
Visceral fat
Percentage
Time frame: 4 and 10 months
energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire
Kcal/week
Time frame: 10 months
High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire
Percentage
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 months
smoking cessation
percentage
Time frame: 10 months
Time to start the rehabilitation programme after discharge from hospital
days
Time frame: 10 months
Returning to work
days
Time frame: 10 months
Pulse wave velocity
m/s
Time frame: 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.
Time frame: 10 months
Cost-effectiveness analysis
net cost divided by changes in health outcomes
Time frame: 10 months
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