Study on Multi-Modality Models of Cardiac Function in Healthy Individuals

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai Ruiwei Digital Technology Co. Ltd.

About this trial

In this study, wearable multi-modal microsensors were deployed to simultaneously capture seismocardiography (SCG) and electrocardiography (ECG) signals, delineating the exercise-load-dependent responsiveness of SCG-ECG dynamic coupling during graded-speed treadmill protocols.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-60 years

Healthy individuals with no significant medical history

Signed informed consent as an acceptance to participate to the trial

Disqualifiers

History of severe cardiovascular, cerebrovascular, pulmonary, hepatic, renal, psychiatric, or other critical systemic disorders

Peripheral vascular diseases, musculoskeletal disorders, or other conditions limiting physical mobility

Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg)

History of anemia

Trial design

Design model

Single group

Treatments tested in this trial

  • Multiple speed increments from 3km/h to 8km/h on a treadmill

    Behavioral

    Healthy participants will undergo a fixed experimental protocol of multi-stage treadmill speed walking/running wearing microsensors and a respiratory/metabolic testing mask.

Treatment groups

270 Participants
are divided into 1 treatment group
Group A: Multiple speed increments on a treadmill for healthy individualsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Seismocardiography (SCG) Signal Amplitude (m/s²)

Peak-to-peak amplitudes of Seismocardiography (SCG) signals will be measured using a triaxial accelerometer (sampling rate: 500 Hz). The primary parameter assessed is the signal amplitude in meters per second squared (m/s²) per cardiac cycle. Values will be averaged over 30-second artifact-free epochs during rest and exercise stages.

Time frame
The entire test will be completed in approximately 90 minutes.

Secondary outcomes

1

Changes in Electrocardiogram (ECG) R-R Intervals (ms)

R-R intervals, measured in milliseconds (ms), will be derived from a single-lead Electrocardiogram (ECG) recording (sampling rate: 250 Hz). The specific parameter assessed is the time duration between consecutive R-waves. R-peaks will be auto-detected and confirmed by amplitude and slope thresholds. Data will be averaged over 30-second epochs synchronized with SCG signals.

Time frame
The entire test will be completed in approximately 90 minutes.

Other outcomes

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