The utility of personal activity trackers (Fitbit Charge 2) on exercise capacity in patients post acute coronary syndrome [UP-STEP ACS Trial]: a randomised controlled trial protocol

Jason Nogic, Paul Min Thein, James Cameron, Sam Mirzaee, Abdul Ihdayhid, Arthur Nasis, Jason Nogic, Paul Min Thein, James Cameron, Sam Mirzaee, Abdul Ihdayhid, Arthur Nasis

Abstract

Background: The benefits of physical activity and cardiovascular rehabilitation on the reduction of cardiovascular risk are well documented. Despite this, significant barriers and challenges remain in optimizing patient risk factors post acute coronary syndromes (ACS) and ensuring patient compliance. Consumer wearable personal activity trackers represent a cost effective and readily available technology that may aid in this endeavour.

Methods: UP-STEP ACS is a prospective single-blinded, two-arm, parallel, randomized control trial with an aim to enrol 200 patients all undertaking cardiac rehabilitation. It will assess the affect that personal activity monitors have on change in exercise capacity in patients post acute coronary syndromes primarily measured by a six-minute walk test (6MWT). Secondary end points will be the improvement in other cardiovascular risk factors, namely; blood lipid and glucose levels, weight, waist circumference, along with mood, quality of life and cardiac rehabilitation adherence. Patients will be randomized to either receive a personal activity tracker or standard post hospital care during their index event. After the 8- week intervention period, patients will return for a clinical review and repeat of baseline assessments including the 6MWT.

Discussion: The utility and impact on exercise capacity of personal activity trackers in patient's post-acute coronary syndrome has not been assessed. This study aims to add to the scientific evidence emerging regarding the clinical utility and validity of these devices in different patient population groups. If proven to be of benefit, these devices represent a cost effective, easily accessible technology that could aid in the reduction of cardiovascular events.

Trial registration: The trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR). The registration number is ACTRN12617000312347 (28/02/2017).

Keywords: Acute coronary syndrome; Cardiac rehabilitation; Fitbit; Personal activity tracker.

Conflict of interest statement

Ethics approval and consent to participate

The Monash Health Human Research and Ethics Committee, Melbourne, Australia has approved this trial. The reference number is LNR/17/MonH/62. It is the requirement of the trial that informed consent is obtained prior to the enrolment process.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Randomized control trial design and flow

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