Wearable Technology To Reduce Sedentary Behavior And CVD Risk In Older Adults: A Pilot Randomized Clinical Trial

Abstract

Background: Physical exercise is associated with decreased cardiovascular disease (CVD) risk, but recent large-scale trials suggest that exercise alone is insufficient to reduce CVD events in high-risk older adults.

Purpose: This pilot randomized clinical trial aimed to collect critical data on feasibility, safety, and protocol integrity necessary to design a fully powered randomized controlled trial (RCT) and evaluate the impact of combining structured exercise with an intervention designed to enhance non-exercise physical activity (EX+NEPA) compared to EX alone.

Methods: Forty participants aged ≥60 years with moderate-to-high risk of coronary heart disease events were randomly assigned to either the EX+NEPA or EX groups and followed for 20 weeks. Both groups underwent a twice-weekly, 8-week center-based exercise intervention with aerobic and resistance exercises. EX+NEPA group also received a wearable activity tracking device along with behavioral monitoring and feedback throughout the study. Study outcomes were evaluated at 8 and 20 weeks.

Results: Data are presented as adjusted mean change of the differences over time with 95% confidence intervals at 20 weeks. Relative to EX, the change in steps/day at 20 weeks was 1994 (-40.27, 4028) higher for EX+NEPA. For sedentary time at close-out, the EX+NEPA group was -6.8 (-45.2, 31.6) min/day relative to EX. The between-group differences for systolic and diastolic blood pressure were -9.9 (-19.6, -0.3) and -1.8 (-6.9, 3.3) mmHg, respectively.

Conclusion: The addition of wearable technology intervention appeared to positively influence daily activity patterns and changes in blood pressure - potentially improving risk factors for CVD. A fully powered randomized trial is needed to ultimately test this hypothesis.

Keywords: activity monitor; aging; cardiovascular; exercise; physical activity.

Conflict of interest statement

Dr Elizabeth Jackson is a paid consultant for McKesson as well as for UpToDate, Inc. and has served as an expert witness for DeBlase Brown Everly LLP, all relationships are modest. Dr Jackson also received research funding from NIH, Amgen for epidemiology, medication utilization. She also served at the editorial board for American Heart Association (AHA) and served as editor/consultant for American College of Cardiology. Dr Todd M Manini reports grants from NIH and AHA, during the conduct of the study and grants from NIH and Regeneron, outside the submitted work. The authors report no other conflicts of interest in this work.

© 2019 Roberts et al.

Figures

Figure 1

Intervention design characteristics. Exercise intensity was monitored with Borg’s category ration (CR) 10 subjective physical exertion scale and with a heart rate monitor (Polar Ft2, Lake Success, NY). Participants were instructed to walk at a 5–6 (CR10) with periods of 7–8 (CR10). Participants in the EX + NEPA group were instructed to remove Fitbit Zip® prior to exercise session during the intervention phase.

Figure 2

Flow diagram of study progress in the Consolidated Standards of Reporting Trials (CONSORT) Group.

Figure 3

Adjusted mean values from baseline to 20-week follow-up for measures of daily activity (A, B), blood pressure (C, D), aerobic capacity (E), and waist circumference (F). Data are expressed as adjusted mean±standard error. Steps per day and sedentary time are adjusted for wear time of the accelerometer. Mean values were adjusted for: age, sex, and baseline measures.

Figure 4

Adjusted mean values from baseline to 20-week follow-up for lipid (A–D) and fasting glucose (E, F). Data are expressed as adjusted mean change ± standard error. Mean values were adjusted for: age, sex, and baseline measures. Abbreviations: LDL cholesterol, low-density lipoprotein cholesterol; HDL cholesterol, high-density lipoprotein cholesterol.

Figure 5

Adjusted mean values from baseline to 20-week follow-up for biomarkers of inflammatory (A-D) and oxidative stress (E, F). Data are expressed as adjusted mean change±standard error. Log-transformation was used to normalize data distribution. Mean values were adjusted for: age, sex, and baseline measures. Abbreviations: TNF-α, tumor necrosis factor α; E-selectin, endothelium selectin; VCAM-1, vascular cell adhesion molecule-1; MPO, myeloperoxidase; oxLDL, oxidized low-density lipoprotein.