NCT04942977|Completed
Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
Prevention and Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
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Prevention and Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
Sponsor study identifier
Secondary identifiers
OTHER · Other
interventional
67
1 country
2
Study Start
May 28, 2019
Actual (reported)Primary Completion
December 7, 2020
Actual (reported)Study Completion
December 7, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 7, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 28, 2019
Actual (reported)December 7, 2020
Actual (reported)December 7, 2020
Actual (reported)June 12, 2021
Actual (reported)June 29, 2021
Actual (reported)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
Maximal oxygen uptake
10 months
Maximal heart rate
10 months
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.
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
Ernesto Dalli Peydró
Valencia, 46008, Spain
Hospital Politécnico Universitario La Fe
Valencia, 46008, Spain
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.
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.
Ernesto Dalli Peydró, MD
Hospital Arnau de Vilanova. Valencia
67 participants (actual enrollment reported by the registry).
First Submitted
June 12, 2021
First Posted
June 29, 2021
Exercise time
10 months
Lipid parameters
10 months
Glycosylated haemoglobin
10 months
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
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.
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.
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.
Study Start
May 28, 2019
Actual (reported)Primary Completion
December 7, 2020
Actual (reported)Study Completion
December 7, 2020
Actual (reported)Last Updated
June 29, 2021
Record last verified: 2021-06
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