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

NCT06952673 | Recruiting

• 1 other identifier: RW-H-001
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers Only

Keywords

Seismocardiography, ECG, Exercise Responsivity

Outcome Measures

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.

  The entire test will be completed in approximately 90 minutes.

Secondary Outcomes (1)

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

  The entire test will be completed in approximately 90 minutes.

Study Arms (1)

Multiple speed increments on a treadmill for healthy individuals

EXPERIMENTAL

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

Interventions

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.

Multiple speed increments on a treadmill for healthy individuals

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Ruiwei Digital Technology Co. Ltd.: lead

Study Sites (1)

Building 16, Lane 775, Hangdong Road, Shanghai

Shanghai, Shanghai Municipality, 201105, China

RECRUITING

Central Study Contacts

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

CONTACT

+86 13916165236; 13916165236@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: May 1, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)