Remote maintenance cardiac rehabilitation (MAINTAIN): A protocol for a randomised feasibility study

Francesca Denton, Alexander Waddell, Chris Kite, Katie Hesketh, Lou Atkinson, Matthew Cocks, Helen Jones, Harpal Randeva, Nathan Davenport, Richard Powell, Cain Clark, Ioannis Kyrou, Amy E Harwood, Gordon McGregor

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    Abstract

    BACKGROUND: Long-term adherence to exercise is often poor for people with coronary heart disease (CHD) who have completed supervised, centre-based cardiac rehabilitation. The aim of this study is to assess the feasibility of a remotely prescribed, delivered and monitored cardiac rehabilitation intervention using a wearable device to support long-term adherence to exercise and physical activity during maintenance of cardiac rehabilitation.

    METHODS: After completing cardiac rehabilitation, 30 participants with CHD, will be randomised (1:1) to an intervention ( n  = 15) or a usual care group ( n  = 15) in a 12-month feasibility randomised controlled trial (RCT). The intervention will comprise of an exercise consultation, personalised exercise prescription delivered via a wearable activity monitor using biometric feedback, regular monitoring via check-ins, and feedback text-messages for 6-months. Participants will be assessed at baseline (following completion of cardiac rehabilitation) and at three-, six-, and 12-months post-randomisation. The primary outcome will be feasibility, including assessment of eligibility, recruitment, adherence, and acceptability. Secondary outcomes will include exercise capacity, physical activity behaviours, cardiovascular disease risk and quality of life. Semi-structured interviews will be conducted at three-, six-, and 12-months post-randomisation (and with those who drop-out) to explore the acceptability of the study intervention and procedures. A questionnaire will be offered to those who decline participation.

    DISCUSSION: The MAINTAIN study will evaluate the feasibility of conducting a future definitive multi-centre RCT testing a remotely prescribed and monitored long-term mHealth maintenance exercise programme, versus usual care, for people with CHD who have completed cardiac rehabilitation.

    TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT05292287. Registered on 22/03/2022.

    Original languageEnglish
    Number of pages13
    JournalDigital Health
    Volume9
    Early online date15 Feb 2023
    DOIs
    Publication statusE-pub ahead of print - 15 Feb 2023

    Bibliographical note

    This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).

    Keywords

    • coronary heart disease
    • exercise maintenance
    • cardiac rehabilitation
    • wearable activity monitors
    • digital health
    • mHealth technology

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