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      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

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          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).

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          Most cited references33

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          How many steps/day are enough? Preliminary pedometer indices for public health.

          Pedometers are simple and inexpensive body-worn motion sensors that are readily being used by researchers and practitioners to assess and motivate physical activity behaviours. Pedometer-determined physical activity indices are needed to guide their efforts. Therefore, the purpose of this article is to review the rationale and evidence for general pedometer-based indices for research and practice purposes. Specifically, we evaluate popular recommendations for steps/day and attempt to translate existing physical activity guidelines into steps/day equivalents. Also, we appraise the fragmented evidence currently available from associations derived from cross-sectional studies and a limited number of interventions that have documented improvements (primarily in body composition and/or blood pressure) with increased steps/day.A value of 10000 steps/day is gaining popularity with the media and in practice and can be traced to Japanese walking clubs and a business slogan 30+ years ago. 10000 steps/day appears to be a reasonable estimate of daily activity for apparently healthy adults and studies are emerging documenting the health benefits of attaining similar levels. Preliminary evidence suggests that a goal of 10000 steps/day may not be sustainable for some groups, including older adults and those living with chronic diseases. Another concern about using 10000 steps/day as a universal step goal is that it is probably too low for children, an important target population in the war against obesity. Other approaches to pedometer-determined physical activity recommendations that are showing promise of health benefit and individual sustainability have been based on incremental improvements relative to baseline values. Based on currently available evidence, we propose the following preliminary indices be used to classify pedometer-determined physical activity in healthy adults: (i). or=10000 steps/day indicates the point that should be used to classify individuals as 'active'. Individuals who take >12500 steps/day are likely to be classified as 'highly active'.
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            AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update: Consensus Panel Guide to Comprehensive Risk Reduction for Adult Patients Without Coronary or Other Atherosclerotic Vascular Diseases. American Heart Association Science Advisory and Coordinating Committee.

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              Validity of consumer-based physical activity monitors.

              Many consumer-based monitors are marketed to provide personal information on the levels of physical activity and daily energy expenditure (EE), but little or no information is available to substantiate their validity. This study aimed to examine the validity of EE estimates from a variety of consumer-based, physical activity monitors under free-living conditions. Sixty (26.4 ± 5.7 yr) healthy males (n = 30) and females (n = 30) wore eight different types of activity monitors simultaneously while completing a 69-min protocol. The monitors included the BodyMedia FIT armband worn on the left arm, the DirectLife monitor around the neck, the Fitbit One, the Fitbit Zip, and the ActiGraph worn on the belt, as well as the Jawbone Up and Basis B1 Band monitor on the wrist. The validity of the EE estimates from each monitor was evaluated relative to criterion values concurrently obtained from a portable metabolic system (i.e., Oxycon Mobile). Differences from criterion measures were expressed as a mean absolute percent error and were evaluated using 95% equivalence testing. For overall group comparisons, the mean absolute percent error values (computed as the average absolute value of the group-level errors) were 9.3%, 10.1%, 10.4%, 12.2%, 12.6%, 12.8%, 13.0%, and 23.5% for the BodyMedia FIT, Fitbit Zip, Fitbit One, Jawbone Up, ActiGraph, DirectLife, NikeFuel Band, and Basis B1 Band, respectively. The results from the equivalence testing showed that the estimates from the BodyMedia FIT, Fitbit Zip, and NikeFuel Band (90% confidence interval = 341.1-359.4) were each within the 10% equivalence zone around the indirect calorimetry estimate. The indicators of the agreement clearly favored the BodyMedia FIT armband, but promising preliminary findings were also observed with the Fitbit Zip.
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                Author and article information

                Contributors
                03 9594 6666 , jngoic@gmail.com
                paul.thein@monashhealth.org
                james.cameron@monash.edu
                sammirzaee@hotmail.com
                abdul.ihdayhid@monashhealth.org
                Arthur.nasis@monashhealth.org
                Journal
                BMC Cardiovasc Disord
                BMC Cardiovasc Disord
                BMC Cardiovascular Disorders
                BioMed Central (London )
                1471-2261
                29 December 2017
                29 December 2017
                2017
                : 17
                : 303
                Affiliations
                MonashHeart, Monash Health and Monash Cardiovascular Research Centre, 246 Clayton Road, Clayton, Melbourne, VIC 3168 Australia
                Author information
                http://orcid.org/0000-0002-5024-0729
                Article
                726
                10.1186/s12872-017-0726-8
                5747185
                29284402
                e4ca156b-e709-4255-923d-f17b641b9cc9
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 30 July 2017
                : 4 December 2017
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2017

                Cardiovascular Medicine
                fitbit,personal activity tracker,cardiac rehabilitation,acute coronary syndrome

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