Effectiveness of activity-monitoring devices in patients with cardiovascular disease participating in cardiac rehabilitation programs: an umbrella review protocol : JBI Evidence Synthesis

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Effectiveness of activity-monitoring devices in patients with cardiovascular disease participating in cardiac rehabilitation programs: an umbrella review protocol

Dafny, Hila Ariela1,2; Champion, Stephanie1,2; Gebremichael, Lemlem G.1,2; Pearson, Vincent1; Nesbitt, Katie1,2; Pinero de Plaza, Maria Alejandra1,2,3; Bulto, Lemma N.1,2; Noonan, Sara1; Hines, Sonia2,4; Hendriks, Jeroen M.1,2,5; Clark, Robyn A.1,2; Beleigoli, Alline1,2

Author Information
doi: 10.11124/JBIES-22-00011
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Abstract

Introduction

Cardiovascular disease (CVD) is a broad term encompassing a range of conditions that affect the heart and blood vessels, including coronary heart disease, stroke, heart failure, arrhythmias, and vascular diseases.1 Several known, modifiable risk factors contribute to the likelihood of an individual developing CVD, including physical inactivity, unhealthy diets, obesity, diabetes, and alcohol and tobacco consumption.2

Globally, CVD is the most common cause of death, contributing to approximately 31% of all deaths in 2016.2,3 The proportion of global deaths resulting from CVD has declined since 1978, mainly owing to early diagnosis improvements, prevention, and early intervention and disease management.4 Emerging evidence demonstrates that decline in coronary heart disease mortality rates has slowed, especially in high-income countries, but may be rising in some populations because of the increasing prevalence of obesity and diabetes.5

Cardiovascular mortality and morbidity are preventable with early diagnosis, intervention, and appropriate management.2 Secondary prevention in exercise-based cardiac rehabilitation programs following a diagnosis with CVD is key to reducing mortality and morbidity of people living with coronary artery disease.6

Cardiac rehabilitation is any medically supervised exercise and education program offered with the intent of secondary CVD prevention, to support recovery after a cardiac event, and to minimize the impact of the disease and minimize the risk of future heart problems. Cardiac rehabilitation can reduce the likelihood of an individual having a further cardiac event, improve patients’ quality of life,7 and potentially reduce health care costs through prevention and early detection.8

Recommended cardiac rehabilitation programs include several key components, including education and activities to promote healthy lifestyles, improve quality of life, and increase physical activity; education about cardiovascular symptoms and risk factors; dietary advice; psychological support; and facilitating a return to work and normal daily living activities.5 The physical activity component is considered critical for enabling lifelong behavior change and supporting long-term health of cardiac rehabilitation patients.9 International guidelines for exercise-based cardiac rehabilitation recommend patients achieve 20 to 60 minutes of moderate-intensity exercise, incorporating strength- and endurance-building exercises, on at least three days each week for the duration of a cardiac rehabilitation program.6

Exercise-based cardiac rehabilitation is often offered in supervised, clinic-based settings.6 For patients unable to attend cardiac rehabilitation in a clinic, telehealth rehabilitation programs are an effective alternate model of care.10 Telehealth rehabilitation programs deliver health care remotely using communication technologies, such as telephone; video; sensors; wearable activity monitoring devices; and smart phone applications, such as text messaging and apps.11 Telehealth overcomes many accessibility barriers preventing the uptake and adherence to cardiac rehabilitation programs, but often cannot include supervised exercise coaching.12 Mobile health technologies using mobile communication devices, text messaging, and smartphone apps to collect health information and provide health services to patients13,14 may offer a way to collect physical activity data to enable remote monitoring of patient physical activity within telehealth rehabilitation programs.12

Wearable activity monitoring devices, combined with smartphone apps, have been used effectively to monitor activity remotely and provide personalized physical activity coaching to cardiac rehabilitation patients.15,16 There are numerous devices and apps used in cardiac health services.17 Wearable mobile applications, such as physical activity–monitoring devices, include pedometers, accelerometers, activity monitors, and step-counting smart phone apps using in-device sensors to provide patients with objective feedback for self-monitoring their physical activity.18 Contemporary wearable devices collect a wide range of physiological movement and energy expenditure measures, including duration, frequency, and intensity of physical activity; heart rate; and step count.19 Activity-tracking apps most commonly collect data on step count, distance traveled, and time spent in activity.20

Globally, activity-monitoring devices are worn by over 10% of adults and are growing in popularity.21 Almost 20% of smartphone users already use a health-related app on their smartphone.14 Apps to promote physical activity in cardiac patients have been found to increase cardiac rehabilitation engagement.14 Text messages and mobile apps (as part of the health-service delivery) are effective in improving outcomes for cardiac rehabilitation patients,15 and wearable technology has been found to increase the amount of physical activity cardiac patients engage in, as well as their adherence to activity recommendations.21

A preliminary search of PROSPERO, MEDLINE, the Cochrane Database of Systematic Reviews, and JBI Evidence Synthesis was conducted, and several recent systematic reviews on the effectiveness of exercise-based cardiac rehabilitation, with and without wearables and apps, were identified.6,9,12,21 These recent systematic reviews of the effectiveness of wearables and apps when included in exercise-based cardiac rehabilitation have noted the need for more extensive studies with greater sample sizes, and participant follow-up for more extended periods.12,21 One umbrella review of randomized controlled trials and experimental systematic reviews investigating the effectiveness of fitness trackers as tools for physical activity interventions is currently in progress.22 This umbrella review differs from the one proposed here as the central focus of the identified umbrella review is not patients with CVD participating in cardiac rehabilitation programs.

This review will capture the broad scope of potential benefits and limitations related to the use of monitoring devices and apps on physical activity behaviors and clinical health outcomes of patients with CVD participating in cardiac rehabilitation programs. There are multiple reviews on different monitoring devices and applications,12,21 and bringing them together in a single review will help answer questions about their effectiveness. This review will summarize the evidence on the effectiveness of activity-monitoring devices and mobile applications as intervention tools. It will focus on the effect of the use of monitoring devices and applications, versus non-use of monitoring devices and mobile applications, on physical activity and health clinical outcomes restricted to patients with CVD participating in cardiac rehabilitation programs.

Review questions

What is the effect of activity-monitoring devices and mobile applications on physical activity levels (including, but not limited to, steps per day, heart rate, energy expenditure, sedentary time, activity intensity, minutes of activity per day) in patients participating in cardiac rehabilitation programs?

What is the effect of activity-monitoring devices and mobile applications on clinical outcomes (mortality rate, incidence of myocardial infarction, revascularizations, and hospital admissions) in patients participating in cardiac rehabilitation programs?

Inclusion criteria

Participants

This umbrella review will consider systematic reviews that include patients of all ages who have CVD, independent of the degree of severity of the disease, in an outpatient cardiac rehabilitation program.

Interventions

This umbrella review will consider systematic reviews that compare interventions that utilized activity-monitoring devices and mobile applications to encourage patients to increase their physical activity level within cardiac rehabilitation programs. Furthermore, systematic reviews that utilized activity-monitoring devices and mobile applications to assess the health outcomes of an activity intervention within cardiac rehabilitation programs will be considered. Activity-monitoring devices and mobile applications may include pedometers, accelerometers, wrist-worn monitors (such as Fitbit, Garmin), smart watches (such as Apple Watch, Samsung Watch), smartphone applications (such as Strava, MyFitnessPal), and text messaging programs. Physical activity interventions may include supervised or unsupervised outpatient, community, home-based, telehealth, or web-based interventions that include training with patients alone or in conjunction with other heart health education. All modes of cardiac rehabilitation delivery, including center-based, home-based, telehealth, web-based, and hybrid programs, will be included regardless of the duration, frequency, or intensity of the program.

Comparator

This umbrella review will consider systematic reviews that compare the effect of physical activity interventions utilizing activity-monitoring devices or mobile applications to non-use of the monitoring devices and mobile applications on physical activity and health outcome of patients with CVD participating in cardiac rehabilitation programs.

Outcomes

This umbrella review will consider systematic reviews that include both physical activity outcomes and clinical health outcomes. Systematic reviews that include at least one outcome measure evaluating physical activity outcomes assessed using activity-monitoring devices or mobile applications monitoring steps per day, heart rate, energy expenditure, sedentary time, activity intensity, or minutes of activity per day will be considered. This umbrella review will also consider systematic reviews that include patient clinical health outcomes, including mortality rate, incidence of myocardial infarction (based on clinical diagnosis and troponin levels), revascularizations, and hospital admissions (longer than 24 hours).

Types of studies

This umbrella review will consider systematic reviews and/or meta-analyses of randomized controlled trials.

Methods

The proposed review will follow the JBI methodology for umbrella reviews.23 This protocol has been registered in PROSPERO (CRD42022298877).

Search strategy

The search strategy will aim to locate both published and unpublished systematic reviews. An initial limited search of MEDLINE (Ovid) and the Cochrane Database of Systematic Reviews was undertaken to identify articles on the topic. The search strategy, including all identified keywords and index terms, will be adapted for each included information source. The preliminary search strategy using the MEDLINE (Ovid) database is presented in Appendix I. The reference lists of all studies selected for critical appraisal will be screened for additional systematic reviews.

Systematic reviews published in any language will be included. Systematic reviews published from inception to the present will be included to capture all systematic reviews on this topic. The search strategy, including all identified keywords and index terms, will be adapted for the bibliographic databases MEDLINE (Ovid), Embase (Ovid), Sport Discus, Cochrane Database of Systematic Reviews, Scopus (Elsevier), CINAHL (EBSCO), the International Network of Agencies for Health Technology Assessment, Epistemonikos, and the Web of Science. PROSPERO will be searched for potentially relevant protocols of unpublished systematic reviews.

Study selection

Following the search, all identified citations will be collated and uploaded into EndNote v.20 (Clarivate Analytics, PA, USA) and duplicates removed. Following a pilot test, titles and abstracts will then be screened by two independent reviewers for assessment against the inclusion criteria for the review. Potentially relevant systematic reviews will be retrieved in full and their citation details imported into the JBI System for the Unified Management, Assessment and Review of Information (JBI SUMARI; JBI, Adelaide, Australia).24 The full text of selected citations will be assessed in detail against the inclusion criteria by two independent reviewers. The systematic review will record and report reasons for exclusion of full-text studies that do not meet the inclusion criteria. Any disagreements that arise between the reviewers at each stage of the study selection process will be resolved through discussion or with a third reviewer. The results of the search and study selection and inclusion process will be reported in full in the final systematic review and presented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram.25

Assessment of methodological quality

Two independent reviewers will critically appraise eligible systematic reviews at the study level for methodological quality in the review using the JBI critical appraisal instrument for systematic reviews.23 Authors of papers will be contacted to request missing or additional data for clarification, where required. Any disagreements that arise between the reviewers will be resolved through discussion or with a third reviewer. The critical appraisal results will be reported in a table with an accompanying narrative. All systematic reviews, regardless of the results of their methodological quality, will undergo data extraction and synthesis (where possible), as the results may assist with data interpretation.

Data extraction

Data will be extracted from included systematic reviews by two independent reviewers using the standardized JBI data extraction tool available in JBI SUMARI.26 The data extracted will include specific details about the populations, study methods, interventions, and outcomes of significance to the review question. From each eligible systematic review, the following information will be extracted: name of the first author and year of publication, physical activity outcomes (including, but not limited to, steps per day, heart rate, energy expenditure, sedentary time, activity intensity, minutes of activity per day), and patient clinical health outcomes (including mortality rate, incidence of myocardial infarction, revascularizations, and hospital admissions), number of systematic reviews included, total population, number of people who received the intervention, effect sizes (risk ratio, odds ratio, hazard ratio, or standardized weighted difference), and mode of measurement of physical activity using monitoring devices and apps. Any disagreements that arise between the reviewers will be resolved through discussion or with a third reviewer. Authors of papers will be contacted to request missing or additional data, where required.

Data synthesis

Findings will be presented in a narrative format, including summary tables and figures to aid in data presentation, where appropriate. Subgroup analyses will be conducted where there are sufficient data to investigate thematic areas of interest, such as outcomes by dose and frequency of cardiac rehabilitation programs and modes of service deliveries. Meta-analysis results from individual systematic reviews will be reported, but findings will not be pooled or reanalyzed.23 Health outcomes will be categorized as improved, negative, and no difference. Where meta-analysis was performed in the included review, effect sizes (risk ratio, odds ratio, hazard ratio, or standardized weighted difference) for outcome measures and tests of quality will be presented. A summary of existing research syntheses or meta-analyses from the included reviews will be reported.

Assessing certainty in the findings

The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach for grading the certainty of evidence will be followed,27 and a Summary of Findings will be created using GRADEpro 2021 (McMaster University, ON, Canada). The Summary of Findings will present the following information where appropriate: absolute risks for the treatment and control, estimates of relative risk, and a ranking of the quality of the evidence based on the risk of bias, directness, heterogeneity, precision, and risk of publication bias of the review results. The outcomes reported in the Summary of Findings will be steps per day, energy expenditure, sedentary time, minutes of activity per day, the ratio of physically active patients or sedentary patients, patient mortality, and hospital admissions.

Acknowledgments

Flinders University Caring Futures Institute, Better Care (College of Nursing and Health Sciences) and clinical leaders, Professor Alison Kitson and Professor Raymond Chan, for founding and facilitating the systematic review group. Flinders University librarians, Mrs Shannon Brown and Ms Josephine McGill, for supporting the development of our search strategy and providing feedback on the content of this protocol.

Funding

RAC was supported by the Flinders University Caring Futures Institute (Cardiac Focus Area Research Grant, 2021).

Author contributions

HD and SC designed the study, developed the protocol, and performed the search strategy. All authors (AB, LG, MAPP, KN, LB, VP, SN, SH, JH, RC) critically reviewed, revised, and approved the submission of the protocol. RC supervised the project.

Appendix I: Search strategy

MEDLINE (Ovid)

<1946 to Dec 16, 2021>

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References

1. Australian Institute of Health and Welfare. Heart, stroke and vascular disease—Australian facts [internet]. Canberra: Australian Institute of Health and Welfare; 2021 [cited 2021 Dec 15]. Available from: https://www.aihw.gov.au/reports/heart-stroke-vascular-diseases/hsvd-facts/contents/about.
2. World Health Organization. Cardiovascular diseases (CVDs) [internet]. Geneva: WHO; 2021 [cited 2021 Dec 15]. Available from: https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).
3. Australian Bureau of Statistics. Heart, stroke and vascular disease [internet]. ABS; 2018 [cited 2021 Dec 15]. Available from: https://www.abs.gov.au/statistics/health/health-conditions-and-risks/heart-stroke-and-vascular-disease/latest-release.
4. Mensah GA, Wei GS, Sorlie PD, Fine LJ, Rosenberg Y, Kaufmann PG, et al. Decline in cardiovascular mortality: possible causes and implications. Circ Res 2017; 120 (2):366–380.
5. Price KJ, Gordon BA, Bird SR, Benson AC. A review of guidelines for cardiac rehabilitation exercise programmes: is there an international consensus? Eur J Prev Cardiol 2016; 23 (16):1715–1733.
6. Powell R, McGregor G, Ennis S, Kimani PK, Underwood M. Is exercise-based cardiac rehabilitation effective? A systematic review and meta-analysis to re-examine the evidence. BMJ Open 2018; 8 (3):e019656.
7. Oldridge NB, Guyatt GH, Fischer ME, Rimm AA. Cardiac rehabilitation after myocardial infarction: combined experience of randomized clinical trials. JAMA 1988; 260 (7):945–950.
8. Muzny M, Henriksen A, Giordanengo A, Muzik J, Grøttland A, Blixgård H, et al. Wearable sensors with possibilities for data exchange: Analyzing status and needs of different actors in mobile health monitoring systems. Int J Med Inform 2020; 133:104017.
9. Lawler PR, Filion KB, Eisenberg MJ. Efficacy of exercise-based cardiac rehabilitation post–myocardial infarction: A systematic review and meta-analysis of randomized controlled trials. Am Heart J 2011; 162 (4):571–584. e2.
10. Clark RA, Conway A, Poulsen V, Keech W, Tirimacco R, Tideman P. Alternative models of cardiac rehabilitation: a systematic review. Eur J Prev Cardiol 2015; 22 (1):35–74.
11. Wade V, Stocks N. The use of telehealth to reduce inequalities in cardiovascular outcomes in Australia and New Zealand: a critical review. Heart Lung Circ 2017; 26 (4):331–337.
12. Rawstorn JC, Gant N, Direito A, Beckmann C, Maddison R. Telehealth exercise-based cardiac rehabilitation: a systematic review and meta-analysis. Heart 2016; 102 (15):1183–1192.
13. Chatterjee A, Gerdes MW, Martinez S. eHealth initiatives for the promotion of healthy lifestyle and allied implementation difficulties. 2019 International Conference on Wireless and Mobile Computing, Networking and Communications (WiMob); 2019. IEEE; 1-8 p.
14. Chow CK, Ariyarathna N, Islam SMS, Thiagalingam A, Redfern J. mHealth in cardiovascular health care. Heart Lung Circ 2016; 25 (8):802–807.
15. Villarreal V, Berbey-Alvarez A. Evaluation of mHealth applications related to cardiovascular diseases: a systematic review. Acta Inform Med 2020; 28 (2):130.
16. Meinhart F, Stütz T, Sareban M, Kulnik ST, Niebauer J. Mobile technologies to promote physical activity during cardiac rehabilitation: a scoping review. Sensors 2021; 21 (1):65.
17. Redfern J. Can older adults benefit from smart devices, wearables, and other digital health options to enhance cardiac rehabilitation? Clin Geriatr Med 2019; 35 (4):489–497.
18. McCallum C, Rooksby J, Gray CM. Evaluating the impact of physical activity apps and wearables: interdisciplinary review. JMIR mHealth uHealth 2018; 6 (3):e9054.
19. Butte NF, Ekelund U, Westerterp KR. Assessing physical activity using wearable monitors: measures of physical activity. Med Sci Sports Exerc 2012; 44 (1S):S5–S12.
20. Simões P, Silva AG, Amaral J, Queirós A, Rocha NP, Rodrigues M. Features, behavioral change techniques, and quality of the most popular mobile apps to measure physical activity: systematic search in app stores. JMIR mHealth uHealth 2018; 6 (10):e11281.
21. Hannan AL, Harders MP, Hing W, Climstein M, Coombes JS, Furness J. Impact of wearable physical activity monitoring devices with exercise prescription or advice in the maintenance phase of cardiac rehabilitation: systematic review and meta-analysis. BMC Sports Sci Med Rehabil 2019; 11 (1):1–21.
22. Maher C, Olds T, Curtis R, Ferguson T, Crozier A, Daikiw K, et al. The effectiveness of fitness tracker interventions: an umbrella review [internet]. PROSPERO 2021.
23. Aromataris E, Fernandez R, Godfrey C, Holly C, Khalil H, Tungpunkom P. Aromataris E, Munn Z. Chapter 10: Umbrella reviews. JBI, JBI Manual for Evidence Synthesis [internet]. Adelaide:2020.
24. Munn Z, Aromataris E, Tufanaru C, Stern C, Porritt K, Farrow J, et al. The development of software to support multiple systematic review types: the Joanna Briggs Institute System for the Unified Management, Assessment and Review of Information (JBI SUMARI). JBI Evid Implement 2019; 17 (1):36–43.
25. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372:n71.
26. Aromataris E, Fernandez R, Godfrey CM, Holly C, Khalil H, Tungpunkom P. Summarizing systematic reviews: methodological development, conduct and reporting of an umbrella review approach. Int J Evid Based Healthc 2015; 13 (3):132–140.
27. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336 (7650):924–926.
Keywords:

activity monitoring; cardiac rehabilitation; physical activity; systematic review; wearables

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