The MAINTAIN study is a protocol for a 12-month randomized feasibility trial evaluating a remotely monitored mHealth exercise program versus usual care in patients with coronary heart disease.
RCT (n=15)
randomized
Does a remotely prescribed and monitored mHealth maintenance exercise programme improve feasibility and adherence in people with CHD who have completed cardiac rehabilitation?
This protocol describes a feasibility RCT evaluating a remote, wearable-based cardiac rehabilitation maintenance program for patients with coronary heart disease.
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: = 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.
Denton et al. (Sun,) conducted a rct in Coronary heart disease (CHD) (n=15). Remotely prescribed and monitored mHealth maintenance exercise programme vs. Usual care was evaluated on Feasibility, including assessment of eligibility, recruitment, adherence, and acceptability. The MAINTAIN study is a protocol for a 12-month randomized feasibility trial evaluating a remotely monitored mHealth exercise program versus usual care in patients with coronary heart disease.