Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy

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

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.

Study Overview

• Status: Completed
• Conditions: Angina, Unstable; ST-segment Elevation Myocardial Infarction (STEMI); Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
• Intervention / Treatment: Device: telemonitoring; Other: Centre-based cardiac rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46008
    • Ernesto Dalli Peydró
  • Valencia, Spain, 46008
    • Hospital Politécnico Universitario la Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac tele-rehabilitation; 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.	Device: telemonitoring; The system consists of the following elements: Professional website at the hospital, which allows:To set up an individualised care planTo establish the patient's risk profile and targets for improvement.Long-term monitoring of the evolution of cardiovascular risk factors and events that occurredAdvise the patient on self-management strategies.; Mobile application software with the following functions:Scheduled exercise sessionsMedication reminderMeasurement 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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Catcronic Salut SL
• Investigators: Principal Investigator: Ernesto Dalli Peydró, MD, Hospital Arnau de VIlanova. Valencia

Publications and helpful links

General Publications

• 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.
• Ambrosetti M, Abreu A, Corra 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 7:2047487320913379. doi: 10.1177/2047487320913379. Online ahead of print.
• 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 record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): December 7, 2020
• Study Completion (Actual): December 7, 2020

Study Registration Dates

• First Submitted: June 12, 2021
• First Submitted That Met QC Criteria: June 20, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 20, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: mobile health; secondary prevention; telerehabilitation; cardiac rehabilitation; monitoring
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable
• Other Study ID Numbers: TSB2014; 484/14/EC (Other Identifier: Other)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No