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

Digit Health. 2023 Feb 15:9:20552076231152176. doi: 10.1177/20552076231152176. eCollection 2023 Jan-Dec.

Authors

Francesca Denton¹, Alexander Waddell¹, Chris Kite^{1

2

3}, Katie Hesketh⁴, Lou Atkinson⁵, Matthew Cocks⁴, Helen Jones⁴, Harpal Randeva², Nathan Davenport⁶, Richard Powell^{1

6}, Cain Clark^{1

2}, Ioannis Kyrou^{1

2

7

8

9}, Amy E Harwood¹, Gordon McGregor^{1

6

9}

Affiliations

¹ Institute of Health and Wellbeing, Coventry University, Coventry, UK.
² Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism (WISDEM), University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
³ School of Public Health Studies, Faculty of Education, Health and Wellbeing, University of Wolverhampton, Wolverhampton, UK.
⁴ Research Institute of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.
⁵ School of Psychology, College of Health and Life Sciences, Aston University, Birmingham, UK.
⁶ UK Department of Cardiopulmonary Rehabilitation, Centre for Exercise & Health, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK.
⁷ Aston Medical School, College of Health and Life Sciences, Aston University, Birmingham, UK.
⁸ Laboratory of Dietetics and Quality of Life, School of Food and Nutritional Sciences, Department of Food Science & Human Nutrition, Agricultural University of Athens, Athens, Greece.
⁹ Warwick Medical School, University of Warwick, Coventry, UK.

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

Associated data

ClinicalTrials.gov/NCT05292287

Grants and funding

MR/T032189/1/MRC_/Medical Research Council/United Kingdom