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

Study on the 'Seismocardiography-Electrocardiography' Coupling Dynamics and Its Exercise-load Reactivity Model in Healthy Individuals

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06952673
Enrollment
270
Registered
2025-05-01
Start date
2025-04-25
Completion date
2026-12-31
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers Only

Keywords

Seismocardiography, ECG, Exercise Responsivity

Brief summary

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.

Detailed description

The heart adapts to varying exercise loads primarily by augmenting heart rate and contractility to achieve matching increases in cardiac output. However, whether there exists an intrinsic triaxial regulatory mechanism governing the interdependencies among 'exercise load - heart rate response - contractility response' remains unknown. In this study, participants performed treadmill exercise at multiple speed gradients (3-8 km/h). Seismocardiography (SCG) signals were captured via an inertial measurement unit (IMU) positioned on the precordium and were used to characterize mechanical cardiac contractility. Single-lead precordial ECG provided heart rate dynamics, while CPET-derived oxygen uptake (VO₂) indexed exercise intensity. The primary objectives were to delineate SCG-ECG responsivity patterns under graded exercise intensities and quantify potential intrinsic laws linking exercise load, heart rate adaptation, and contractility modulation.

Interventions

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

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

Sponsors

Shanghai Ruiwei Digital Technology Co. Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-60 years * Healthy individuals with no significant medical history * Signed informed consent as an acceptance to participate to the trial

Exclusion criteria

* 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 * Moderate to severe obesity (BMI ≥32.5 kg/m²) * Pregnant or lactating women * Any other conditions deemed ineligible for participation per investigator's discretion

Design outcomes

Primary

MeasureTime frameDescription
Changes in Seismocardiography (SCG) Signal Amplitude (m/s²)The entire test will be completed in approximately 90 minutes.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.

Secondary

MeasureTime frameDescription
Changes in Electrocardiogram (ECG) R-R Intervals (ms)The entire test will be completed in approximately 90 minutes.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.

Countries

China

Contacts

CONTACTSEN WANG, M.D., Ph. D.,
13916165236@163.com+86 13916165236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026