Effectiveness of Home-Based Mobile Guided Cardiac Rehabilitation as Alternative Strategy for Nonparticipation in Clinic-Based Cardiac Rehabilitation among Elderly Patients in Europe: A Randomized Clinical Trial

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  • Johan A. Snoek
  • Prescott, Eva
  • Astrid E. Van Der Velde
  • Thijs M.H. Eijsvogels
  • Nicolai Mikkelsen
  • Leonie F. Prins
  • Wendy Bruins
  • Esther Meindersma
  • José R. González-Juanatey
  • Carlos Peña-Gil
  • Violeta González-Salvado
  • Feriel Moatemri
  • Marie Christine Iliou
  • Thimo Marcin
  • Prisca Eser
  • Matthias Wilhelm
  • Arnoud W.J. Van'T Hof
  • Ed P. De Kluiver

Importance: Although nonparticipation in cardiac rehabilitation is known to increase cardiovascular mortality and hospital readmissions, more than half of patients with coronary artery disease in Europe are not participating in cardiac rehabilitation. Objective: To assess whether a 6-month guided mobile cardiac rehabilitation (MCR) program is an effective therapy for elderly patients who decline participation in cardiac rehabilitation. Design, Setting, and Participants: Patients were enrolled in this parallel multicenter randomized clinical trial from November 11, 2015, to January 3, 2018, and follow-up was completed on January 17, 2019, in a secondary care system with 6 cardiac institutions across 5 European countries. Researchers assessing primary outcome were masked for group assignment. A total of 4236 patients were identified with a recent diagnosis of acute coronary syndrome, coronary revascularization, or surgical or percutaneous treatment for valvular disease, or documented coronary artery disease, of whom 996 declined to start cardiac rehabilitation. Subsequently, 179 patients who met the inclusion and exclusion criteria consented to participate in the European Study on Effectiveness and Sustainability of Current Cardiac Rehabilitation Programmes in the Elderly trial. Data were analyzed from January 21 to October 11, 2019. Interventions: Six months of home-based cardiac rehabilitation with telemonitoring and coaching based on motivational interviewing was used to stimulate patients to reach exercise goals. Control patients did not receive any form of cardiac rehabilitation throughout the study period. Main Outcomes and Measures: The primary outcome parameter was peak oxygen uptake (Vo2peak) after 6 months. Results: Among 179 patients randomized (145 male [81%]; median age, 72 [range, 65-87] years), 159 (89%) were eligible for primary end point analysis. Follow-up at 1 year was completed for 151 patients (84%). Peak oxygen uptake improved in the MCR group (n = 89) at 6 and 12 months (1.6 [95% CI, 0.9-2.4] mL/kg-1/min-1and 1.2 [95% CI, 0.4-2.0] mL/kg-1/min-1, respectively), whereas there was no improvement in the control group (n = 90) (+0.2 [95% CI, -0.4 to 0.8] mL/kg-1/min-1and +0.1 [95% CI, -0.5 to 0.7] mL/kg-1/min-1, respectively). Changes in Vo2peak were greater in the MCR vs control groups at 6 months (+1.2 [95% CI, 0.2 to 2.1] mL/kg-1/min-1) and 12 months (+0.9 [95% CI, 0.05 to 1.8] mL/kg-1/min-1). The incidence of adverse events was low and did not differ between the MCR and control groups. Conclusions and Relevance: These results suggest that a 6-month home-based MCR program for patients 65 years or older with coronary artery disease or a valvular intervention was safe and beneficial in improving Vo2peak when compared with no cardiac rehabilitation. Trial Registration: trialregister.nl Identifier: NL5168.

Original languageEnglish
JournalJAMA Cardiology
Volume6
Issue number4
Pages (from-to)463-468
ISSN2380-6583
DOIs
Publication statusPublished - 2021

Bibliographical note

Funding Information:
reported receiving grants from European Union’s Horizon 2020 Research and Innovation Programme during the conduct of the study. Dr van der Velde reported receiving grants from the European Union during the conduct of the study. Dr Eijsvogels reported receiving a personal grant from the Dutch Heart Foundation. Dr Prins reported receiving grants from the European Commission during the conduct of the study and outside the submitted work. Dr Bruins reported receiving grants from Isala Heart Centre during the conduct of the study. Dr Meindersma reported receiving grants from the European Commission during the conduct of the study. Dr Peña-Gil reported receiving grants from European Commission during the conduct of the study. Dr González-Salvado reported receiving grants from the European Union during the conduct of the study. Dr Iliou reported receiving personal fees and nonfinancial support from Servier Laboratories, nonfinancial support from Novartis International AG and Sanofi SA, and personal fees from AstraZeneca outside the submitted work. Dr Marcin reported receiving grants from the Swiss National Fond during the conduct of the study. Dr Van’t Hof reported receiving grants from the European Union during the conduct of the study and grants from Medtronic plc, AstraZeneca, and Abbott Laboratories outside the submitted work. Dr de Kluiver reported receiving grants from the European Union during the conduct of the study and having an indirect interest in HC@home/ Mobihealth, which provided the hardware and software for this study, outside the submitted work. No other disclosures were reported.

Funding Information:
Funding/Support: This study was supported by grant 634439 from the European Union’s Horizon 2020 Research and Innovation Programme and contract 15.0139 from the Swiss State Secretariat for Education, Research and Innovation.

Funding Information:
This study was supported by grant 634439 from the European Union's Horizon 2020 Research and Innovation Programme and contract 15.0139 from the Swiss State Secretariat for Education, Research and Innovation.

Publisher Copyright:
© 2021 American Medical Association. All rights reserved.

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