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BackgroundAlternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. ObjectiveThe aim of this study is to compare the effects and costs of the innovative Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) intervention with usual care CR. MethodsIn this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. ResultsThe trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. ConclusionsThe innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. Trial RegistrationAustralian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. International Registered Report Identifier (IRRID)DERR1-10.2196/15022

BackgroundBlood pressure (BP) is an important modifiable cardiovascular risk factor, yet its long-term monitoring remains problematic. Wearable cuffless devices enable the capture of multiple BP measures during everyday activities and could improve BP monitoring, but little is known about their validity or acceptability. ObjectiveThis study aimed to validate a wrist-worn cuffless wearable BP device (Model T2; TMART Technologies Limited) and assess its acceptability among users and health care professionals. MethodsA mixed methods study was conducted to examine the validity and comparability of a wearable cuffless BP device against ambulatory and home devices. BP was measured simultaneously over 24 hours using wearable and ambulatory devices and over 7 days using wearable and home devices. Pearson correlation coefficients compared the degree of association between the measures, and limits of agreement (LOA; Bland-Altman plots) were generated to assess measurement bias. Semistructured interviews were conducted with users and 10 health care professionals to assess acceptability, facilitators, and barriers to using the wearable device. Interviews were audio recorded, transcribed, and analyzed. ResultsA total of 9090 BP measurements were collected from 20 healthy volunteers (mean 20.3 years, SD 5.4; N=10 females). Mean (SD) systolic BP (SBP)/diastolic BP (DBP) measured using the ambulatory (24 hours), home (7 days), and wearable (7 days) devices were 126 (SD 10)/75 (SD 6) mm Hg, 112 (SD 10)/71 (SD 9) mm Hg and 125 (SD 4)/77 (SD 3) mm Hg, respectively. Mean (LOA) biases and precision between the wearable and ambulatory devices over 24 hours were 0.5 (−10.1 to 11.1) mm Hg for SBP and 2.24 (−17.6 to 13.1) mm Hg for DBP. The mean biases (LOA) and precision between the wearable and home device over 7 days were −12.7 (−28.7 to 3.4) mm Hg for SBP and −5.6 (−20.5 to 9.2) mm Hg for DBP. The wearable BP device was well accepted by participants who found the device easy to wear and use. Both participants and health care providers agreed that the wearable cuffless devices were easy to use and that they could be used to improve BP monitoring. ConclusionsWearable BP measures compared well against a gold-standard ambulatory device, indicating potential for this user-friendly method to augment BP management, particularly by enabling long-term monitoring that could improve treatment titration and increase understanding of users’ BP response during daily activity and stressors.

BackgroundThe use of embedded smartphone sensors offers opportunities to measure physical activity (PA) and human movement. Big data—which includes billions of digital traces—offers scientists a new lens to examine PA in fine-grained detail and allows us to track people’s geocoded movement patterns to determine their interaction with the environment. ObjectiveThe objective of this study was to examine the validity of the Movn smartphone app (Moving Analytics) for collecting PA and human movement data. MethodsThe criterion and convergent validity of the Movn smartphone app for estimating energy expenditure (EE) were assessed in both laboratory and free-living settings, compared with indirect calorimetry (criterion reference) and a stand-alone accelerometer that is commonly used in PA research (GT1m, ActiGraph Corp, convergent reference). A supporting cross-validation study assessed the consistency of activity data when collected across different smartphone devices. Global positioning system (GPS) and accelerometer data were integrated with geographical information software to demonstrate the feasibility of geospatial analysis of human movement. ResultsA total of 21 participants contributed to linear regression analysis to estimate EE from Movn activity counts (standard error of estimation [SEE]=1.94 kcal/min). The equation was cross-validated in an independent sample (N=42, SEE=1.10 kcal/min). During laboratory-based treadmill exercise, EE from Movn was comparable to calorimetry (bias=0.36 [−0.07 to 0.78] kcal/min, t82=1.66, P=.10) but overestimated as compared with the ActiGraph accelerometer (bias=0.93 [0.58-1.29] kcal/min, t89=5.27, P

Females with type 2 diabetes (T2D) have a 25–50% greater risk of developing cardiovascular disease compared with males. While aerobic exercise training is effective for improving cardiometabolic health outcomes, there is limited sex-segregated evidence on the feasibility of aerobic training in adults with T2D. A secondary analysis of a 12-week randomized controlled trial examining aerobic training in inactive adults with T2D was conducted. Feasibility outcomes were recruitment, retention, treatment fidelity, and safety. Sex differences and intervention effects were assessed using two-way analyses of variances. Thirty-five participants (14 females) were recruited. The recruitment rate was significantly lower among females (9% versus 18%; p = 0.022). Females in the intervention were less adherent (50% versus 93%; p = 0.016), and experienced minor adverse events more frequently (0.08% versus 0.03%; p = 0.003). Aerobically trained females experienced clinically meaningful reductions in pulse wave velocity (−1.25 m/s, 95%CI [−2.54, 0.04]; p = 0.648), and significantly greater reductions in brachial systolic pressure (−9 mmHg, 95%CI (3, 15); p = 0.011) and waist circumference (−3.8 cm, 95%CI (1.6, 6.1); p < 0.001) than males. To enhance the feasibility of future trials, targeted strategies to improve female recruitment and adherence are needed. Females with T2D may experience greater cardiometabolic health improvements from aerobic training than males. [ABSTRACT FROM AUTHOR]

Objective: Compare the effects and costs of remotely monitored exercise-based cardiac telerehabilitation (REMOTE-CR) with centre-based programmes (CBexCR) in adults with coronary heart disease (CHD).Methods: Participants were randomised to receive 12 weeks of telerehabilitation or centre-based rehabilitation. REMOTE-CR provided individualised exercise prescription, real-time exercise monitoring/coaching and theory-based behavioural strategies via a bespoke telerehabilitation platform; CBexCR provided individualised exercise prescription and coaching via established rehabilitation clinics. Outcomes assessed at baseline, 12 and/or 24 weeks included maximal oxygen uptake (V̇O2max, primary) modifiable cardiovascular risk factors, exercise adherence, motivation, health-related quality of life and programme delivery, hospital service utilisation and medication costs. The primary hypothesis was a non-inferior between-group difference in V̇O2max at 12 weeks (inferiority margin=-1.25 mL/kg/min); inferiority margins were not set for secondary outcomes.Results: 162 participants (mean 61±12.7 years, 86% men) were randomised. V̇O2 max was comparable in both groups at 12 weeks and REMOTE-CR was non-inferior to CBexCR (REMOTE-CR-CBexCR adjusted mean difference (AMD)=0.51 (95% CI -0.97 to 1.98) mL/kg/min, p=0.48). REMOTE-CR participants were less sedentary at 24 weeks (AMD=-61.5 (95% CI -117.8 to -5.3) min/day, p=0.03), while CBexCR participants had smaller waist (AMD=1.71 (95% CI 0.09 to 3.34) cm, p=0.04) and hip circumferences (AMD=1.16 (95% CI 0.06 to 2.27) cm, p=0.04) at 12 weeks. No other between-group differences were detected. Per capita programme delivery (NZD1130/GBP573 vs NZD3466/GBP1758) and medication costs (NZD331/GBP168 vs NZD605/GBP307, p=0.02) were lower for REMOTE-CR. Hospital service utilisation costs were not statistically significantly different (NZD3459/GBP1754 vs NZD5464/GBP2771, p=0.20).Conclusion: REMOTE-CR is an effective, cost-efficient alternative delivery model that could-as a complement to existing services-improve overall utilisation rates by increasing reach and satisfying unique participant preferences. [ABSTRACT FROM AUTHOR]