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Cardiopulmonary Exercise Active Health Cohort Study (CEAHCS)

2026년 11월 7일 업데이트: Peking University Third Hospital

This is a multicenter, prospective, observational cohort study. Study participants will first be enrolled into the general population main cohort, and some eligible subjects will be invited to participate in a validation study for the consistency of estimated VO₂max. The overall study consists of the establishment of the main cohort and three major research modules: cardiovascular endpoint risk prediction, early warning of exercise-related cardiovascular event risk, and health reminder and behavioral feedback. In addition, a substudy is designed to enroll 300 patients with stable metabolic cardiovascular disease, aiming to verify the consistency between wearable-device-estimated maximal oxygen uptake (VO₂max) and the gold standard of Cardiopulmonary Exercise Testing (CPET), so as to evaluate the applicability and error structure of the device-estimated parameters in clinical populations.

연구 개요

상태

모병

정황

상세 설명

To establish a prospective cardiopulmonary exercise and active health cohort based on wearable devices, systematically integrate continuous dynamic physiological and behavioral data as well as standardized clinical outcome information, and evaluate the application value of wearable-device-derived metrics in dynamic cardiovascular risk assessment and exercise-related risk identification. Specific objectives are as follows:

To verify the agreement between wearable-device-estimated VO₂max and CPET measurements.
To assess the association between continuously monitored wearable metrics and Major Adverse Cardiovascular Events (MACE), and develop a long-term risk prediction model.
To evaluate the relationship between short-term physiological change features during exercise or physical activity and exercise-related cardiovascular events, and explore methods for dynamic identification of exercise risk.
To assess the association between health prompts delivered via wearable feedback and individual behavioral and risk changes, and explore the feasibility of active health management.

연구 유형

관찰

등록 (추정된)

10000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

중국
- Beijing Municipality
  - Beijing, Beijing Municipality, 중국, 100191
    - 모병
    - Peking University Third Hospital
    - 연락하다:
      
      YiDa Tang
      
      전화번호: +86-10-82265820
      
      이메일: shentao90@bjmu.edu.cn
    - 연락하다:
      
      Tao Shen
      
      전화번호: +86-18201648870
      
      이메일: shentao90@bjmu.edu.cn

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Recruited from volunteers in the general population or health check-up attendees.

설명

Inclusion Criteria:

Voluntarily participate in the study and sign the informed consent form; agree to continuously wear the wearable device during follow-up; able to complete scheduled follow-up visits
Enrolled in the main cohort; having stable metabolic cardiovascular diseases (such as hypertension, type 2 diabetes mellitus (T2DM), or dyslipidemia); voluntarily sign the supplementary informed consent for the CPET substudy

Exclusion Criteria:

Severe mental disorder or cognitive impairment, unable to understand the study content; individuals who cannot or are unsuitable to wear the device
Presence of contraindications to CPET (e.g., uncontrolled acute coronary syndrome, acute heart failure, severe arrhythmia, etc.); functional impairment that substantially limits exercise capacity; pregnancy or lactation

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: COHORT
시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
general healthy population This group consists of generally healthy individuals without chronic diseases such as hypertension, dyslipidemia, diabetes mellitus, coronary artery disease, and chronic obstructive pulmonary disease (COPD)
Participants with metabolic cardiovascular risk The exposure factors of this group are hypertension, dyslipidemia, diabetes mellitus, coronary artery disease (CAD), heart failure (HF), and chronic obstructive pulmonary disease (COPD). All of these chronic diseases have been diagnosed in the participants.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Major Adverse Cardiovascular Events (MACE) 기간: From the date of baseline enrollment until the date of first MACE or censoring, assessed up to 12 months.	Cardiovascular endpoint events: defined as major events meeting the criteria for MACE (including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke), extended to other clinically significant adverse cardiovascular events such as heart failure hospitalization, unstable angina visit, and revascularization.All events will be adjudicated by at least two cardiologists based on device recordings, medical documentation and self-reported symptoms. Any disagreements will be resolved by a third-party adjudicator.	From the date of baseline enrollment until the date of first MACE or censoring, assessed up to 12 months.
Exercise-Related Cardiovascular Events 기간: From the date of baseline enrollment until the date of first exercise-related cardiovascular event or censoring, assessed up to 12 months.	Definition of Exercise-Related Cardiovascular Events: Cardiovascular symptoms or events closely induced by exercise that occur during exercise or in the post-exercise recovery period, including but not limited to: (1) Myocardial infarction or angina attack; (2) Tachyarrhythmias: ventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation, paroxysmal supraventricular tachycardia occurring during exercise or recovery; (3) Bradyarrhythmias: newly developed sinus arrest, atrioventricular block, left/right bundle branch block; (4) Abnormal exercise blood pressure: systolic blood pressure ≥210 mmHg (male) or ≥190 mmHg (female) during exercise, abrupt blood pressure drop >10 mmHg with evidence of ischemia during exercise; (5) Syncope, sudden cardiac death, cardiac arrest; (6) Other cardiovascular events resulting in exercise termination. Wearable devices will be used to identify exercise episodes and analyze dynamic physiological characteristics during exercise and recov	From the date of baseline enrollment until the date of first exercise-related cardiovascular event or censoring, assessed up to 12 months.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Peking University Third Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 11일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 10월 19일

QC 기준을 충족하는 최초 제출

2026년 11월 7일

처음 게시됨 (실제)

2026년 11월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)