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Personal activity intelligence e-health program in people with type 2 diabetes: a pilot randomized controlled trial
Coombes JS, Keating SE, Mielke GI, Fassett RG, Coombes BK, O' Leary KP, Cox ER, Burton NW
Medicine and Science in Sports and Exercise 2022 Jan;54(1):18-27
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

INTRODUCTION: Innovative strategies are needed to enable people with type 2 diabetes (T2D) to self-manage physical activity (PA). Personal Activity Intelligence (PAI) is a new metric that uses the heart rate response to PA to inform the user as to whether they are doing enough PA to reduce the risk of premature mortality. The PAI score reflects PA over the previous 7 d with the goal to maintain a score >= 100. The aim of this study was to investigate the feasibility, acceptability, and efficacy of the PAI e-Health Program in people with T2D. METHODS:Thirty participants with T2D who were not meeting PA guidelines were randomly assigned to 12 week of either (1) PAI e-Health Program or (2) PA attention control. The PAI e-Health Program consisted of receiving a wrist-worn heart rate monitor and an app with the PAI metric, and attending 4 x 2 h per week sessions of exercise and counseling. Feasibility and acceptability of the program were evaluated by achievement of a PAI score >= 100 and participant feedback. Efficacy was determined from changes in glycemic control, cardiorespiratory fitness, exercise capacity (time-on-test), body composition, sleep time, and health-related quality of life. RESULTS: Program participants in the PAI e-Health Program had a mean +/- SD PAI score of 119.7 +/- 60.6 and achieved >= 100 PAI on 56.4% of the days. The majority of participants (80%) intended to continue to use PAI monitoring. Compared with control, the PAI group significantly improved their exercise capacity (mean difference, 95% confidence interval) (63 s, 17.9 to 108.0 s), sleep time (67.2 min, 7.2 to 127.1 min), total percent body fat (-1.3%, -2.6% to -0.1%), and gynoid fat percent (-1.5%, -2.6 to -0.5). CONCLUSIONS: The PAI e-Health Program is feasible, acceptable, and efficacious in people with T2D.

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