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Enrolling by Invitation

NCT Number: NCT07330882

Health Behavior Management Program for Patients With Coronary Heart Disease

Coronary artery disease (CAD) is a major chronic condition severely impacting population health in China. Our previous cohort studies revealed a high comorbidity rate between CAD and frailty, suggesting their interrelated equivalence as clinical syndromes with shared risk factors. In recent years, pilot integrated health management initiatives in China have demonstrated promising outcomes, yet evidence remains scarce regarding patients with concurrent CAD and frailty-a critical gap needing urgent resolution to achieve the "Healthy China 2030" strategic goals.

Building on prior research, this project aims to systematically evaluate existing management models for patients with CAD and frailty, develop a tailored health management framework, and implement it in clinical settings through empirical studies. The model will be optimized according to regional and demographic variations, leveraging cardiac rehabilitation centers, exercise-based interventions, and internet-enabled technologies to enhance coordinated care. By improving exercise efficacy, mitigating frailty progression, and enhancing quality of life, this initiative seeks to establish a robust chronic disease management system. The findings will provide evidence for formulating regional health policy and insurance strategies in Anhui Province, ultimately improving standardized management rates for chronic diseases.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Coronary heart disease;
  • Proficiency in smartphone use;
  • Absence of visual, auditory, cognitive, or motor impairments.

Exclusion criteria

  • Inability or unwillingness to provide informed consent;
  • Physical or cognitive limitations preventing app operation;
  • Inability to attend in-person follow-up visits;
  • Concurrent severe comorbidities or malignancies, such as severe valvular heart disease, New York Heart Association class IV heart failure, severe aortic regurgitation, cancer, end-stage renal or liver disease;
  • Any other condition that could potentially impede exercise participation.

Treatment and study plan

Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology

Behavioral

The development, application and evaluation of an innovative health management model for patients with coronary heart disease and frailty based on the "cardiac rehabilitation center" framework, exercise rehabilitation, and new technologies such as "mobile health".

Primary outcomes

  1. 6MWD

    Time frame: 1month,3 months, 6 months

    Measuring the maximum distance within 6 minutes.

  2. The MOS item short from health survey

    Time frame: 1month,3 months, 6 months

    Quality of life was assessed using the 36-Item Short Form Health Survey questionnaire

Secondary outcomes

  1. Frailty

    Time frame: 1month,3 months, 6 months

    The FRAIL Scale

  2. Grip strength

    Time frame: 1month,3 months, 6 months

    Electronic grip device

  3. Gait speed

    Time frame: 1month,3 months, 6 months

    Stopwatch

  4. Physical activity level

    Time frame: 1month,3 months, 6 months

    The short version self-reported International Physical Activity Questionnaire.

  5. Systolic pressure/Diastolic pressure

    Time frame: 1month,3 months, 6 months

    Calibrated electronic blood pressure monitor

  6. Major cardiovascular adverse events

    Time frame: 1month,3 months, 6 months

    Major Adverse Cardiovascular Events (MACE) were defined as at least one of the following: heart failure, malignant arrhythmia, recurrent angina, recurrent myocardial infarction, cardiogenic shock, cardiac arrest, or sudden cardiac death.

  7. Changes in Blood Lipid Biomarkers

    Time frame: 1 month, 3 months, 6 months

    Changes in blood lipid biomarkers, including triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were assessed.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Bengbu Medical University

Other

Registry information

Official study title

Health Behavior Management Program for Patients With Coronary Heart Disease: A Clinical Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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