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Randomized Controlled Trial
. 2015 May 7:15:29.
doi: 10.1186/s12872-015-0021-5.

Telerehab III: a multi-center randomized, controlled trial investigating the long-term effectiveness of a comprehensive cardiac telerehabilitation program--rationale and study design

Ines Frederix  1   2 , Dominique Hansen  3 , Karin Coninx  4 , Pieter Vandervoort  5   6 , Emeline M Van Craenenbroeck  7 , Christiaan Vrints  8 , Paul Dendale  9   10
Affiliations
Randomized Controlled Trial

Telerehab III: a multi-center randomized, controlled trial investigating the long-term effectiveness of a comprehensive cardiac telerehabilitation program--rationale and study design

Ines Frederix et al. BMC Cardiovasc Disord. .

Abstract

Background: Telerehabilitation has been proposed as an adjunct/alternative to standard center-based cardiac rehabilitation. Two recent systematic reviews showed non-inferiority and/or superiority of this remote approach for cardiac rehabilitation. However, these trials focused only on one core component of cardiac rehabilitation and telemonitoring, rather than implementing a more comprehensive approach. The aim of Telerehab III is to investigate the long-term effectiveness of the addition of a patient-tailored, internet-based telerehabilitation program implementing multiple cardiac rehabilitation core components and using both telemonitoring and telecoaching strategies to standard cardiac rehabilitation.

Methods/design: In this prospective, multi-center randomized, controlled trial 140 patients with coronary artery disease and/or chronic heart failure patients will be recruited between February 2013 and February 2015. Patients will be randomized 1:1 to an intervention group (receiving an internet-based telerehabilitation program in addition to standard cardiac rehabilitation) or to standard cardiac rehabilitation alone. The mean follow-up is at least 6 months. The primary endpoint is peak oxygen consumption (VO2 peak). Secondary endpoints include measured and self-reported daily physical activity, cardiovascular risk factor control, health-related quality of life, days lost due to (non)cardiovascular rehospitalizations and time to first (non)cardiovascular rehospitalization. A clinical event committee blinded to treatment allocation assesses causes of rehospitalizations.

Discussion: Telerehab III will be one of the first studies to examine the added value of a more comprehensive cardiac telerehabilitation program, focusing on multiple cardiac rehabilitation core components. It has the potential to augment current standard center-based cardiac rehabilitation practices and to be used as a model for other disease prevention programs.

Trial registration: Current controlled trials ISRCTN29243064. Registration date 21 January 2015.

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Figures

Fig. 1
Fig. 1
Flow chart for patient inclusion and follow-up. Screening, inclusion and exclusion, randomization and tests at baseline and follow-up. CR: Cardiac Rehabilitation; IPAQ: International Physical Activity Questionnaire; HeartQol: quality of life questionnaire; EQ-5D: EuroQol questionnaire; CPET: CardioPulmonary Exercise Testing; TTE: TransThoracic Echocardiography
Fig. 2
Fig. 2
Algorithm defining intensity, frequency, duration and volume characteristics of exercise training protocols used in the telerehabilitation program
See this image and copyright information in PMC

References

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