Author(s): MCNAMARA, C., PAOLI, M., Institution: CONSENSUS HEALTH, Country: UNITED STATES, Abstract-ID: 127

INTRODUCTION:
Sedentary behavior and persistent fatigue increase cardiometabolic and mental-health risk. Brief daily exercise prescriptions can improve outcomes but adherence is poor. MOVe tests whether adding nightly heart rate variability (HRV) biofeedback to an 11-min/day brisk-walking prescription accelerates physiologic and symptomatic improvement and increases early adherence in primary care.
METHODS:
Pragmatic, two-arm, parallel, single-blinded (outcome assessor) randomized controlled trial. Adults 18–75 who are sedentary (<150 min/wk MVPA) with Fatigue Assessment Scale (FAS) >=22 are randomized 1:1 (stratified by clinic and baseline FAS) to: (1) standardized counseling + 11-min/day brisk walking (control) or (2) same plus nightly 5-min resting HRV recording with Polar H10 and daily RMSSD feedback via a consumer wrist activity device and clinician dashboard (intervention). Exclusions: unstable cardiovascular disease, arrhythmia precluding HRV analysis, current structured exercise, pregnancy. HRV processing uses R-R extraction, automated artifact detection and interpolation, with RMSSD and SDNN calculated from artifact-corrected 5-min windows. Assessments at baseline, 1, 3, and 6 months. Primary endpoints at 3 months: device-measured exercise adherence (minutes/day and proportion achieving >=11 min/day) and change in fatigue (FAS). Secondary endpoints: time to RMSSD increase >=10 ms, continuous RMSSD/SDNN change, sleep (PSQI), EQ-5D, and 6-month maintenance. Primary analysis by intention-to-treat using mixed-effects models (participant and clinic random effects), adjusted for baseline covariates; hierarchical testing (adherence then FAS). Mediation analysis will assess whether early HRV change (1 month) mediates adherence and fatigue at 3 months. Sample size: N=224 (allowing 15% attrition) to detect a 20% absolute increase in adherence (40% vs 60%) with 80% power, alpha=0.05.
RESULTS:
Planned primary outcomes are device-measured minutes/day of brisk walking and proportion achieving >=11 min/day at 3 months, plus mean change in FAS score at 3 months. Secondary outcomes include time-to-RMSSD improvement, RMSSD/SDNN trajectories, PSQI and EQ-5D changes, and retention at 6 months. Recruitment is planned across primary-care clinics with target sample N=224; analysis will report between-arm differences (effect sizes, 95% CIs, p-values) for primary and secondary endpoints.
CONCLUSION:
The MOVe trial evaluates a scalable HRV biofeedback adjunct to brief exercise prescriptions in routine primary care. If the intervention increases early adherence and reduces fatigue via rapid autonomic improvement, it offers a pragmatic pathway to translate short daily exercise prescriptions into sustained health behavior change and clinical benefit.

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