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

April 22, 2026 updated by: Shanghai Ruiwei Digital Technology Co. Ltd.

Study on the 'Seismocardiography-Electrocardiography' Coupling Dynamics and Its Exercise-load Reactivity Model 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201105
        • Recruiting
        • Building 16, Lane 775, Hangdong Road, Shanghai
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multiple speed increments on a treadmill for healthy individuals
Healthy participants will undergo the following experimental protocol: After wearing microsensors and a respiratory/metabolic testing mask, they will rest quietly for 3 minutes, then begin walking at a speed of 3 km/h for 6 minutes, followed by a 3-minute quiet rest period. This will be followed by walking at 4 km/h for 6 minutes and another 3-minute rest. The protocol continues with subsequent stages at progressively increasing speeds of 5 km/h, 6 km/h, 7 km/h, and 8 km/h, each involving 6 minutes of walking followed by 3 minutes of rest.
Behavioral: Multiple 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The entire test will be completed in approximately 90 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The entire test will be completed in approximately 90 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Ruiwei Digital Technology Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 19, 2025

First Submitted That Met QC Criteria

April 29, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RW-H-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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