Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 26, 2021
Open Peer Review Period: May 26, 2021 - Jul 21, 2021
Date Accepted: Aug 18, 2021
Date Submitted to PubMed: Aug 19, 2021
(closed for review but you can still tweet)
Efficacy and safety of remote cardiac rehabilitation in the recovery phase of cardiovascular diseases: A protocol paper
ABSTRACT
Background:
Conventional group-based outpatient cardiac rehabilitation through monitoring and center-based approaches for patients in the recovery phase has shown strong evidence for the prevention of cardiovascular diseases. However, there are some cases in which maintaining attendance of center-based cardiac rehabilitation is difficult.
Objective:
This study aims to ascertain the safety and efficacy of remote cardiac rehabilitation (RCR) in the recovery phase in patients with cardiovascular disease.
Methods:
Patients satisfying the study criteria will be recruited from multiple institutions (approximately 30) across Japan. Seventy-five patients (approximately two or three patients from each institution) are proposed to be recruited. To patients enrolled in the RCR group, devices necessary for RCR (calibrated ergometers and tablets) will be lent. Patients will perform anaerobic exercise at home using ergometer for 30-40 minutes at least three times weekly. During exercise, an instructor will monitor the patient in real time (using interactive video tools and monitoring tools for various vital data). Moreover, educational instructions will be given three times weekly using e-learning methods.
Results:
The primary endpoint is the peak oxygen uptake 2–3 months from the start of exercise or 6 min walk test. The extracted data will be compared between RCR patients and controls without RCR. This study was funded in December 2020 and received ethical approval in January 2021, and recruitment began in January 2021. 59 study patients had been recruited by March 2021.
Conclusions:
The establishment of the system of RCR proposed in this study will lead to the development of more extensive applications, which have been insufficient with conventional interventions. Clinical Trial: Clinical Trials Registry (UMIN–CTR; UMIN000042942)
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