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NCT Number: NCT06952673

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Building 16, Lane 775, Hangdong Road, Shanghai

Shanghai, Shanghai Municipality, 201105, China

Location status: Recruiting

Location contact

SEN WANG, M.D., Ph. D.,

CONTACT

[email protected]

+86 13916165236

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

SEN WANG, M.D., Ph. D.,

CONTACT

[email protected]

+86 13916165236

Sponsors and collaborators

Lead sponsor

Shanghai Ruiwei Digital Technology Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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