NCT04942977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

1.5 years

First QC Date

June 12, 2021

Last Update Submit

June 20, 2021

Conditions

Angina, UnstableNon-ST-Segment Elevation Myocardial Infarction (NSTEMI)ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

mobile healthmonitoringcardiac rehabilitationtelerehabilitationsecondary prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (23)

  • Maximal oxygen uptake

    10 months

  • Maximal heart rate

    10 months

  • Exercise time

    10 months

  • Lipid parameters

    10 months

  • Glycosylated haemoglobin

    10 months

  • +18 more secondary outcomes

Study Arms (2)

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.

Device: telemonitoring

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.

Other: Centre-based cardiac rehabilitation

Interventions

telemonitoringDEVICE

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

Cardiac tele-rehabilitation
Centre-based cardiac rehabilitationOTHER

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.

Centre-based cardiac rehabilitation

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ernesto Dalli Peydró

Valencia, 46008, Spain

Location

Hospital Politécnico Universitario La Fe

Valencia, 46008, Spain

Location

Related Publications (6)

  • 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.

    PMID: 33611446BACKGROUND

  • 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.

    PMID: 31082266BACKGROUND

  • 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.

    PMID: 25475219BACKGROUND

  • 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.

    PMID: 33623986BACKGROUND

  • 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.

    PMID: 30971111BACKGROUND

  • 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.

    PMID: 26206311BACKGROUND

MeSH Terms

Conditions

Angina, UnstableNon-ST Elevated Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial InfarctionInfarctionIschemiaPathologic ProcessesNecrosis

Study Officials

  • Ernesto Dalli Peydró, MD

    Hospital Arnau de Vilanova. Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Phase III clinical trial, feasibility, controlled and randomized, with two arms: cardiac telerehabilitation (intervention group) and centre-based cardiac rehabilitation (control group)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2021

First Posted

June 29, 2021

Study Start

May 28, 2019

Primary Completion

December 7, 2020

Study Completion

December 7, 2020

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)