Previously submitted to: Journal of Medical Internet Research (no longer under consideration since Apr 18, 2025)
Date Submitted: Sep 6, 2024
Open Peer Review Period: Sep 9, 2024 - Nov 4, 2024
(closed for review but you can still tweet)
NOTE: This is an unreviewed Preprint
Warning: This is a unreviewed preprint (What is a preprint?). Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn (a note "no longer under consideration" will appear above).
Peer review me: Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period (in this case, a "Peer Review Me" button to sign up as reviewer is displayed above). All preprints currently open for review are listed here. Outside of the formal open peer-review period we encourage you to tweet about the preprint.
Citation: Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author).
Final version: If our system detects a final peer-reviewed "version of record" (VoR) published in any journal, a link to that VoR will appear below. Readers are then encourage to cite the VoR instead of this preprint.
Settings: If you are the author, you can login and change the preprint display settings, but the preprint URL/DOI is supposed to be stable and citable, so it should not be removed once posted.
Submit: To post your own preprint, simply submit to any JMIR journal, and choose the appropriate settings to expose your submitted version as preprint.
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Sustaining cardiac rehabilitation delivery throughout COVID-19 lock-down: results from the SCRAM telerehabilitation randomized controlled trial
ABSTRACT
Background:
Accessibility barriers contribute to low participation in center-based cardiac rehabilitation. We developed an innovative, comprehensive, dual-phase telerehabilitation program to address this gap (Smartphone Cardiac Rehabilitation Assisted Self-Management; SCRAM).
Objective:
To determine the effectiveness of SCRAM for increasing maximal aerobic exercise capacity (VO2max).
Methods:
A multi-center, parallel two-arm randomized controlled trial recruited clinically stable adults (aged 18+ years) with diagnosed coronary heart disease at three hospitals in Victoria, Australia (Melbourne, Geelong, Bendigo) from 2018-2021. Participants were randomized (1:1), stratified by sex and study site, to receive SCRAM plus usual cardiovascular care (intervention), or usual cardiovascular care alone (control). SCRAM intervention provided 24 weeks of remote exercise supervision, coaching, and behavior change support via smartphone. Usual cardiovascular care included standard medical care and advice to seek a referral to centre-based cardiac rehabilitation (CR), which was heavily impacted during the COVID-19 pandemic. Due to the nature of the treatments, participants were not blinded to allocation; primary outcome assessors and biostatisticians were blinded. The primary outcome was VO2max at 24 weeks, analyzed on the principle of intention-to-treat, using linear regression adjusted for baseline and stratification factors on multiple imputed data.
Results:
Recruitment and data collection were heavily impacted by COVID-19, although SCRAM delivery was sustained throughout. Of 220 required participants, only 123 (56%) were recruited and randomized (intervention n=63, control n=60); 45% had missing VO2max at 24 weeks—largely due to enforced COVID-19 restrictions. VO2max at 24 weeks favored SCRAM, but this was not statistically significant (mean difference=1.61 ml/kg/min; 95% CI [-1.38, 4.61], P=.28). Among secondary outcomes, patients receiving SCRAM had lower diastolic blood pressure at 24 weeks (mean difference=-5.54 mmHg; 95% CI [-10.01, -1.06]).
Conclusions:
SCRAM was resilient to COVID-19-related disruptions to CR delivery but, while findings were inconclusive, it did not lead to a clinically important difference in VO2max. Further research is needed to conclusively assess treatment effects and understand how virtual CR delivery models can be translated into routine practice. Clinical Trial: Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.