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| ID | Type | Description | Link |
|---|---|---|---|
| 484/14/EC | Other Identifier | Other |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac tele-rehabilitation | Experimental | 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. |
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| Centre-based cardiac rehabilitation | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telemonitoring | Device | The system consists of the following elements:
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernesto Dalli Peydró, MD | Hospital Arnau de Vilanova. Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ernesto Dalli Peydró | Valencia | 46008 | Spain | |||
| Hospital Politécnico Universitario La Fe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33611446 | Background | 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. | |
| 31082266 |
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| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Phase III clinical trial, feasibility, controlled and randomized, with two arms: cardiac telerehabilitation (intervention group) and centre-based cardiac rehabilitation (control group)
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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.
|
| Centre-based cardiac rehabilitation | Other | 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. |
|
| 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 |
| Valencia |
| 46008 |
| Spain |
| Background |
| 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. |
| 25475219 | Background | 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. |
| 33623986 | Background | 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. |
| 30971111 | Background | 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. |
| 26206311 | Background | 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. |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |