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

doi:10.1177/20552076231152176

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

^*Corresponding author for this work

Aston Medical School

Institute of Health and Wellbeing, , Coventry, UK Coventry University (RINGGOLD: 2706)
School of Public Health Studies, Faculty of Education, Health and Wellbeing, University of Wolverhampton, Wolverhampton WV1 1LY, UK.; Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism (WISDEM), University Hospitals Coventry and Warwickshire NHS Trust, Coventry CV2 2DX, UK.; Centre for Sport, Exercise and Life Sciences, Research Institute for Health & Wellbeing, Coventry University, Coventry CV1 5FB, UK.
Research Institute of Sport and Exercise Sciences, , Liverpool, UK Liverpool John Moores University (RINGGOLD: 4589)
Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism (WISDEM), , Coventry, UK University Hospitals Coventry and Warwickshire NHS Trust (RINGGOLD: 2708)
Centre for Sport, Exercise and Life Sciences, Research Institute for Health Wellbeing, Coventry University, Coventry CV1 5FB, UK; Department of Cardiopulmonary Rehabilitation, Centre for Exercise Health, University Hospitals Coventry Warwickshire NHS Trust, Coventry CV2 2DX, UK; Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK
Warwick Medical School, 2707 University of Warwick , Coventry, UK

Research output: Contribution to journal › Article › peer-review

7 Citations (SciVal)

10 Downloads (Pure)

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 language	English
Pages (from-to)	1-13
Journal	Digital Health
Volume	9
Early online date	15 Feb 2023
DOIs	https://doi.org/10.1177/20552076231152176
Publication status	Published - 2023

Bibliographical note

Copyright © The Author(s), 2023. Creative Commons CC BY: 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).

Funding: This work is supported by Coventry University as part of a fully funded PhD within the Centre for Sport Exercise and Life Sciences, Research Institute of Health and Wellbeing.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

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

Access to Document

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Cite this

@article{31122e5088ac4533949368a63a61f0d4,

title = "Remote maintenance cardiac rehabilitation (MAINTAIN):: A protocol for a randomised feasibility study",

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",

keywords = "coronary heart disease, exercise maintenance, cardiac rehabilitation, wearable activity monitors, digital health, mHealth technology",

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

note = "Copyright {\textcopyright} The Author(s), 2023. Creative Commons CC BY: 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). Funding: This work is supported by Coventry University as part of a fully funded PhD within the Centre for Sport Exercise and Life Sciences, Research Institute of Health and Wellbeing.",

year = "2023",

doi = "10.1177/20552076231152176",

language = "English",

volume = "9",

pages = "1--13",

journal = "Digital Health",

issn = "2055-2076",

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TY - JOUR

T1 - Remote maintenance cardiac rehabilitation (MAINTAIN):

T2 - A protocol for a randomised feasibility study

AU - Denton, Francesca

AU - Waddell, Alexander

AU - Kite, Chris

AU - Hesketh, Katie

AU - Atkinson, Lou

AU - Cocks, Matthew

AU - Jones, Helen

AU - Randeva, Harpal

AU - Davenport, Nathan

AU - Powell, Richard

AU - Clark, Cain

AU - Kyrou, Ioannis

AU - Harwood, Amy E

AU - McGregor, Gordon

N1 - Copyright © The Author(s), 2023. Creative Commons CC BY: 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). Funding: This work is supported by Coventry University as part of a fully funded PhD within the Centre for Sport Exercise and Life Sciences, Research Institute of Health and Wellbeing.

PY - 2023

Y1 - 2023

N2 - 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

AB - 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

KW - coronary heart disease

KW - exercise maintenance

KW - cardiac rehabilitation

KW - wearable activity monitors

KW - digital health

KW - mHealth technology

UR - https://journals.sagepub.com/doi/10.1177/20552076231152176

UR - https://www.scopus.com/pages/publications/85148351594

U2 - 10.1177/20552076231152176

DO - 10.1177/20552076231152176

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SN - 2055-2076

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JO - Digital Health

JF - Digital Health

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