Study design and population
This prospective observational study was conducted between January 2024 and January 2025 to evaluate whether smartwatch-derived exercise and autonomic parameters could predict incident hypertension among normotensive adults. A total of 230 participants aged 30–60 years were enrolled from outpatient cardiology and preventive medicine clinics. All participants provided written informed consent, and the study protocol was approved by the institutional ethics committee (Approval No: B.30.2.ATA.0.01.00/737) in accordance with the Declaration of Helsinki.
Inclusion criteria: age 30–60 years, baseline systolic BP < 140 mmHg and diastolic BP < 90 mmHg, continuous smartwatch use ≥ 20 days per month during follow-up, willingness to attend scheduled visits, and provision of written informed consent.
Exclusion criteria: known hypertension, coronary artery disease, heart failure or arrhythmia (including atrial fibrillation), current use of antihypertensive, antiarrhythmic, β-blocker, calcium-channel blocker, or ACE inhibitor therapy within 3 months before enrollment, diabetes mellitus, chronic kidney disease (eGFR < 60 mL/min/1.73 m²), thyroid dysfunction, autonomic neuropathy, BMI ≥ 35 kg/m², heavy smoking (> 20 cigarettes/day) or alcohol consumption (> 20 g/day), shift work or irregular sleep–wake patterns, sleep apnea syndrome, missing or incomplete smartwatch data (> 15% missing), technical incompatibility preventing data synchronization, pregnancy, lactation, hormonal therapy, or inability/unwillingness to attend the 12-month follow-up visit.
Smartwatch-derived parameters
Participants wore a validated smartwatch (Apple Watch Series 9 or equivalent) continuously for 12 months. The following parameters were automatically recorded and extracted through the device’s health API: resting heart rate (RHR, bpm), heart rate variability (HRV, RMSSD, ms), moderate-to-vigorous physical activity (MVPA, min/day), sedentary time (min/day), estimated VO₂max (ml/kg/min), sleep efficiency (% of time asleep/time in bed), and stress index (0–100). Monthly mean values and 30-day changes (ΔHRV, ΔRHR, ΔMVPA) were computed. Interaction indices (HRV×MVPA, RHR×Sedentary time) were derived to explore autonomic–activity relationships.
Clinical evaluation
Blood pressure (BP) was measured at baseline and at 12 months using a calibrated oscillometric device after 5 minutes of rest. The mean of the last two of three readings was recorded. Incident hypertension was defined according to the 2023 ESC/ESH guidelines as systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg, or initiation of antihypertensive therapy during follow-up.
Statistical analysis
All analyses were performed using Python 3.12 (pandas, statsmodels, xgboost, lightgbm, shap). Continuous variables were expressed as mean ± SD and categorical variables as percentages. Normality was assessed using the Shapiro–Wilk test. Group comparisons were made with the Student’s t-test or Mann–Whitney U test for continuous variables, and the χ² or Fisher’s exact test for categorical data.
Multivariable logistic regression
Independent predictors of incident hypertension were identified using multivariable logistic regression including age, sex, BMI, HRV, RHR, MVPA, sedentary time, VO₂max, sleep efficiency, and interaction terms (HRV×MVPA, RHR×Sedentary). Adjusted odds ratios (ORs) with 95% confidence intervals (CIs) were calculated. Model calibration was assessed using the Hosmer–Lemeshow test, and discrimination using the area under the ROC curve (AUC).
Machine learning analysis
To complement traditional inference, predictive modeling was performed using Extreme Gradient Boosting (XGBoost) and Light Gradient Boosting Machine (LightGBM) with 10-fold stratified cross-validation. Feature importance was determined via SHAP (Shapley Additive Explanations) analysis. Performance metrics included ROC–AUC, F1-score, accuracy, and average precision, with cross-validated mean AUC and 95% CI reported.
Exploratory and interaction analyses
Restricted cubic spline regression was applied to assess non-linear associations. A partial dependence analysis illustrated the joint effect of HRV and MVPA, demonstrating the highest predicted risk among individuals with both low HRV (< 45 ms) and low MVPA (< 40 min/day). All tests were two-tailed, and a p < 0.05 was considered statistically significant.