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

NCT ID: NCT06952673

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-25
• Study Completion Date: 2025-08-30

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.

Conditions

Healthy Volunteers Only

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Ruiwei Digital Technology Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RW-H-001

Identifier Type: -

Identifier Source: org_study_id