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

Shanghai Ruiwei Digital Technology Co. Ltd.

Status: Not yet enrolling

Conditions: Healthy Volunteers Only

Treatments: Behavioral: Multiple speed increments from 3km/h to 8km/h on a treadmill

Study type: Interventional

Funder types: Industry

Identifiers

NCT06952673

RW-H-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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270 participants in 1 patient group

Multiple speed increments on a treadmill for healthy individuals

Experimental group

Description:

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.

Treatment:

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