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.
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?
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.
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.
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.
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.
The proposed review will follow the JBI methodology for umbrella reviews.23 This protocol has been registered in PROSPERO (CRD42022298877).
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.
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 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.
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.
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.
RAC was supported by the Flinders University Caring Futures Institute (Cardiac Focus Area Research Grant, 2021).
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
<1946 to Dec 16, 2021>
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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
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