Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
- Conditions
- Angina, UnstableNon-ST-Segment Elevation Myocardial Infarction (NSTEMI)ST-segment Elevation Myocardial Infarction (STEMI)
- Interventions
- Device: telemonitoringOther: Centre-based cardiac rehabilitation
- Registration Number
- NCT04942977
- Lead Sponsor
- Catcronic Salut SL
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cardiac tele-rehabilitation telemonitoring 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. Centre-based cardiac rehabilitation Centre-based cardiac rehabilitation 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.
- Primary Outcome Measures
Name Time Method Physical activity derived from the International Physical Activity questionnaire (IPAQ) 10 months 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
Name Time Method Visceral fat 4 and 10 months Percentage
Returning to work 10 months days
Pulse wave velocity 10 months m/s
Maximal oxygen uptake 10 months Maximal oxygen uptake during the final 30 seconds of the cardiopulmonary exercise testing (CPET) (ml/kg/min )
Glycosylated haemoglobin 10 months Percentage
Weight 4 and 10 months Kg
Maximal heart rate 10 months Maximal heart rate at the end of the exercise testing (bpm)
Exercise time 10 months stress test duration (minutes)
Lipid parameters 10 months 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
Waist circumference 4 and 10 months waist circumference change (cm)
energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire 10 months Kcal/week
Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED). 10 months 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) 10 months percentage. Minimum value: 0%, maximum value: 100%. Higher scores mean a better outcome.
High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire 10 months Percentage
Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS) 10 months 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) 10 months 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) 10 months Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
User's experience from the System Usability Scale (SUS) score 10 months Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D) 10 months 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) 10 months Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
smoking cessation 10 months percentage
Time to start the rehabilitation programme after discharge from hospital 10 months days
Cost-effectiveness analysis 10 months net cost divided by changes in health outcomes
Trial Locations
- Locations (2)
Ernesto Dalli Peydró
🇪🇸Valencia, Spain
Hospital Politécnico Universitario La Fe
🇪🇸Valencia, Spain