临床试验雷达

Blood Pressure (office)

Auscultatory BP measurements will be obtained using a calibrated mercury sphygmomanometer and stethoscope applied to the participant's dominant arm. Systolic BP will be identified at the appearance of the first clear tapping sound (Korotkoff phase I), and diastolic BP will be identified at the disappearance of sounds (Korotkoff phase V). The same experienced evaluator, who remains blinded to condition allocation, will perform all auscultatory measurements throughout the study to minimise inter-observer variability.

pre intervention and 15, 30, 45 and 60 min post-intervention

Continuous beat-to-beat Blood Pressure

Continuous beat-to-beat BP will be measured using the Finapres NOVA non-invasive finger arterial pressure monitor. All measurements will be obtained with the participant in the supine position, with the measurement arm supported at heart level to ensure hydrostatic equivalence between the finger and the heart. A finger cuff will be placed on either the index or middle finger of the non-dominant arm, selected based on optimal signal quality, and a brachial calibration cuff will be positioned on the upper arm of the same limb. Data will be exported at a sampling frequency of 200 Hz, providing systolic, diastolic, and mean arterial pressures, pulse pressure, and heart rate for each cardiac cycle

pre-intervention and post-intervention (during all 60 min post-intervention)

Heart Rate and Heart Rate Variability

Heart rate will be monitored continuously using the Polar Unite optical sensor, which uses photoplethysmography to derive heart rate and inter-beat intervals from changes in wrist blood volume. The device will be worn on the dominant wrist and record second-by-second heart rate and high-resolution interval data. HRV analysis will use two stable resting segments: the final 10 minutes of baseline and minutes 50-60 of recovery. Inter-beat intervals will be exported to Kubios HRV Premium for processing. Data will be visually inspected, with artefacts detected at a 0.3-second threshold and corrected via cubic spline interpolation; segments with \>5% corrections or \<5 minutes of valid data will be excluded. HRV parameters will follow Task Force standards.

Pre-intervention and minutes 50-60 of post-intervention.

Cardiac Output

Cardiac output will be estimated using the Modelflow algorithm integrated into the Finapres NOVA system.

Pre-intervention and post-intervention (during all 60 min post-intervention)

Stroke Volume

Stroke volume will be calculated as cardiac output divided by heart rate, then multiplied by 1000 to express it in millilitres

Pre-intervention and post-intervention (during all 60 min post-intervention)

Total peripheral resistance

Total peripheral resistance will be calculated as mean arterial pressure divided by cardiac output, expressed in millilitres of mercury per minute per litre.

pre-intervention and post-intervention (during all 60 min post-intervention)

Baroreflex Sensitivity

Baroreflex sensitivity will be assessed during the same time periods used for heart rate variability analysis: the final 10 minutes of pre-intervention baseline and minutes 50 through 60 of post-intervention recovery. The baroreflex sensitivity will be assessed non-invasively using the sequence method applied to synchronised beat-to-beat BP and inter-beat interval data. This technique identifies spontaneous sequences of consecutive cardiac cycles in which progressive increases or decreases in systolic BP are coupled with corresponding changes in inter-beat interval duration, reflecting the baroreflex-mediated heart rate response to BP fluctuations. Data for this analysis will be obtained by synchronising the continuous systolic BP values from the Finapres system with the inter-beat interval data from the Polar Unite sensor.

Pre-intervention and minutes 50-60 of post-intervention.