Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy

Angina, Unstable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942977
• Other study ID #: TSB2014
• Secondary ID: 484/14/EC
• Status: Completed
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: December 7, 2020

Study information

• Verified date: June 2021
• Source: Catcronic Salut SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)

Intervention

Device:
• telemonitoring
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

Other:
• Centre-based cardiac rehabilitation
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.

Locations

Country	Name	City	State
Spain	Ernesto Dalli Peydró	Valencia
Spain	Hospital Politécnico Universitario La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Catcronic Salut SL

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Ambrosetti M, Abreu A, Corrà U, Davos CH, Hansen D, Frederix I, Iliou MC, Pedretti RF, 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. 2020 Apr 7. pii: 2047487320913379. doi: 10.1177/2047487320913379. [Epub ahead of print] — View Citation

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. — View Citation

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. Review. — View Citation

Reibis R, Salzwedel A, Abreu A, Corra U, Davos C, Doehner W, Doherty P, Frederix I, Hansen D, Christine Iliou M, Vigorito C, Völler 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximal oxygen uptake	Maximal oxygen uptake during the final 30 seconds of the cardiopulmonary exercise testing (CPET) (ml/kg/min )	10 months
Secondary	Maximal heart rate	Maximal heart rate at the end of the exercise testing (bpm)	10 months
Secondary	Exercise time	stress test duration (minutes)	10 months
Secondary	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
Secondary	Glycosylated haemoglobin	Percentage	10 months
Secondary	Weight	Kg	4 and 10 months
Secondary	Waist circumference	waist circumference change (cm)	4 and 10 months
Secondary	Visceral fat	Percentage	4 and 10 months
Secondary	energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire	Kcal/week	10 months
Secondary	High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire	Percentage	10 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	smoking cessation	percentage	10 months
Secondary	Time to start the rehabilitation programme after discharge from hospital	days	10 months
Secondary	Returning to work	days	10 months
Secondary	Pulse wave velocity	m/s	10 months
Secondary	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
Secondary	Cost-effectiveness analysis	net cost divided by changes in health outcomes	10 months