Coronary DiseaseNCT07330882
Health Behavior Management Program for Patients With Coronary Heart Disease
A study testing Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology in people with Coronary Disease, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Coronary heart disease;
- Proficiency in smartphone use;
- Absence of visual, auditory, cognitive, or motor impairments.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Health Behavior Management Program for Patients With Coronary Heart Disease: A Clinical Study
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.
- Conditions
- Coronary Disease
- Being tested
- Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology
- Keywords
- Myocardial Ischemia, Cardiac rehabilitation, Quality of life, Frailty
- Medical subject headings
- Coronary Disease, Myocardial Ischemia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technologyBehavioural
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".
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention consists of two parts: Health management model: Establish a "hospital-home" full-process health management service chain based on mobile health. Firstly, cardiac specialist nurses conduct a comprehensive assessment of each patient's cardiac rehabilitation status and implement individualized interventions. The specific intervention procedures are: "Assess the patient's current condition and capabilities - Promote the patient's awareness of the current situation - Develop and revise the cardiac rehabilitation plan - Supervise the implementation of the cardiac rehabilitation plan." Receives: Behavioral: Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology |
| Control group | Active comparator | During the patient's hospital stay and after discharge, cardiovascular internal medical staff provide them with routine medical,nursing services and health education. In terms of basic drug treatment, the principles of secondary prevention for coronary heart disease should be followed. Routine nursing care and health education were delivered through verbal instruction and the "317 Nursing Education Platform." They were also advised to maintain a healthy lifestyle and participate in appropriate physical activities. Receives: Behavioral: Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWD
Measuring the maximum distance within 6 minutes.
Measured: 1month,3 months, 6 months
The MOS item short from health survey
Quality of life was assessed using the 36-Item Short Form Health Survey questionnaire
Measured: 1month,3 months, 6 months
Secondary outcomes (7)
Frailty
The FRAIL Scale
Measured: 1month,3 months, 6 months
Grip strength
Electronic grip device
Measured: 1month,3 months, 6 months
Gait speed
Stopwatch
Measured: 1month,3 months, 6 months
Physical activity level
The short version self-reported International Physical Activity Questionnaire.
Measured: 1month,3 months, 6 months
Systolic pressure/Diastolic pressure
Calibrated electronic blood pressure monitor
Measured: 1month,3 months, 6 months
Major cardiovascular adverse events
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.
Measured: 1month,3 months, 6 months
Changes in Blood Lipid Biomarkers
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.
Measured: 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start20 Oct 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou,Tong, The First Affiliated Hospital of Bengbu Medical University
- Investigators
- Tong Zhou, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330882
- Sponsor's protocol ID
- FirstAHBBMC
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Behavior Management Program for Patients With Coronary Heart Disease: A Clinical Study
- ClinicalTrials.gov ID
- NCT07330882
- Acronym / sponsor ID
- FirstAHBBMC
- Conditions
- Coronary Disease
- Keywords
- Myocardial Ischemia, Cardiac rehabilitation, Quality of life, Frailty
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technologyThe intervention consists of two parts: Health management model: Establish a "hospital-home" full-process health management service chain based on mobile health. Firstly, cardiac specialist nurses conduct a comprehensive assessment of each patient's cardiac rehabilitation status and implement individualized interventions. The specific intervention procedures are: "Assess the patient's current condition and capabilities - Promote the patient's awareness of the current situation - Develop and revise the cardiac rehabilitation plan - Supervise the implementation of the cardiac rehabilitation plan." |
| Control group | Active comparator | Behavioral: Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technologyDuring the patient's hospital stay and after discharge, cardiovascular internal medical staff provide them with routine medical,nursing services and health education. In terms of basic drug treatment, the principles of secondary prevention for coronary heart disease should be followed. Routine nursing care and health education were delivered through verbal instruction and the "317 Nursing Education Platform." They were also advised to maintain a healthy lifestyle and participate in appropriate physical activities. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Coronary heart disease;
- Proficiency in smartphone use;
- Absence of visual, auditory, cognitive, or motor impairments.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technologyThe 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". | Behavioural | Control group, Intervention group |
Primary outcome
6MWD
Time frame: 1month,3 months, 6 months
Measuring the maximum distance within 6 minutes.
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
7 secondary outcomes
Frailty
Time frame: 1month,3 months, 6 months
Grip strength
Time frame: 1month,3 months, 6 months
Gait speed
Time frame: 1month,3 months, 6 months
Physical activity level
Time frame: 1month,3 months, 6 months
Systolic pressure/Diastolic pressure
Time frame: 1month,3 months, 6 months
Major cardiovascular adverse events
Time frame: 1month,3 months, 6 months
Changes in Blood Lipid Biomarkers
Time frame: 1 month, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tong Zhou principal investigator
The First Affiliated Hospital of Bengbu Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology in people with Coronary Disease, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWD (time frame: 1month,3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.