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Cardiopulmonary Exercise Active Health Cohort Study (CEAHCS)

7 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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:

  1. To verify the agreement between wearable-device-estimated VO₂max and CPET measurements.
  2. To assess the association between continuously monitored wearable metrics and Major Adverse Cardiovascular Events (MACE), and develop a long-term risk prediction model.
  3. 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.
  4. 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.

Type d'étude

Observationnel

Inscription (Estimé)

10000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100191
        • Recrutement
        • Peking University Third Hospital
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Major Adverse Cardiovascular Events (MACE)
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Peking University Third Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 mai 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

19 octobre 2026

Première soumission répondant aux critères de contrôle qualité

7 novembre 2026

Première publication (Réel)

13 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 novembre 2026

Dernière vérification

1 mars 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • M20260266

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data (IPD) will not be shared with other researchers to protect participant privacy and confidentiality, in compliance with local ethical and data governance requirements.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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