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Establishment and evaluation of a novel cardiac rehabilitation system based on “medicine-sports integration” + “medicine-engineering cooperation” in chronic coronary disease

Establishment and evaluation of a novel cardiac rehabilitation system based on “medicine-sports integration” + “medicine-engineering cooperation” in chronic coronary disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112487
Enrollment
Unknown
Registered
2025-11-14
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic coronary disease

Interventions

Part 1:Establishment of a Rehabilitation Program for Chronic Coronary Artery Disease via the Delphi Method:None
Part 2: Cross-Sectional Study Evaluating the Effectiveness of Wearable Devices (Observation Group):None
New rehabilitation Group (Experimental Group):New rehabilitation program
Traditional rehabilitation group (control group):Traditional rehabilitation program

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Engagement in the fields of coronary heart disease, cardiac rehabilitation, or sports science for 10 years or more(part 1); 2.Possession of a postgraduate degree or higher(part 1); 3.Holding an associate senior title or higher(part 1); 4.Employment across different levels of healthcare institutions(part 1); 5.Demonstrated interest in this study, ability to provide valuable insights, and willingness to participate in the entire consultation process(part 1); 6.The patient was diagnosed with coronary artery disease by coronary angiography, and the clinical ischemia symptoms were stable for >2 months(part 2?3);

Exclusion criteria

Exclusion criteria: 1.Experts who rated themselves as "very unfamiliar" with cardiac rehabilitation or sports-related content or provided suboptimal quality responses in the first round of the Delphi survey(part 1); 2.Experts who did not return the first-round Delphi survey questionnaire(part 1); 3.Patients with severe heart failure (LVEF50% (part 2?3); 5.Patients with angina pectoris that cannot be controlled by medication(part 2?3); 6.Patients with acute coronary syndrome within the last 2 months(part 2?3); 7.Patients with skin lesions or infections on the wrist and chest that prevent them from wearing wearable devices(part 2?3); 8.Patients with serious disease, such as tumor, immune disease, and blood disease, affecting life expectancy(part 2?3); 9.Patients with serious bone and joint diseases such as recent fractures(part 2?3); 10.Combined with mental illness, Alzheimer's disease and other cognitive dysfunction patients(part 2?3); 11.Patients cannot be followed up regularly(part 2?3); 12.Patients who refused to participate in the study(part 2?3); 13.Pregnant, pregnant or lactating women(part 2?3); 14.Patients who is unable to participate in exercise rehabilitation for other reasons(part 2?3);

Design outcomes

Primary

MeasureTime frame
Peak VO2;Expert Representativeness (part 1);Expert Enthusiasm (part 1);Expert Authority Level (part 1);Expert Consistency Level (part 1);Expert Opinion Concentration (part 1);During the exercise rehabilitation process, the following indicators will be simultaneously collected: (1) hospital-based professional monitoring devices: heart rate, ECG, blood pressure, respiratory rate, and peripheral capillary oxygen saturation; (2) novel wearable devices: primary indicators including heart rate, ECG, blood pressure, respiratory rate, and peripheral capillary oxygen saturation, as well as additional indicators such as physical activity level, posture, and position. (part 2);Adverse event recording during device use (including: Material safety — number of allergic reactions and severity level to skin-contact materials of the wearable device, as well as skin irritation; Hardware reliability — incidence rate of wearable device malfunctions). (part 2);

Secondary

MeasureTime frame
Adherence of patients;Satisfaction degree of rehabilitation experience;Systolic function and diastolic function of left ventricle;Major adverse cardiac event;Other indices of cardiopulmonary exercise test;The proportion of improvement of quality of life;Any adverse events or non-cardiovascular re-hospitalizations during exercise rehabilitation;Indicators of health economics;

Countries

China

Contacts

Public ContactRen Jingyi

China-Japan Friendship Hospital

renjingyi1213@163.com+86 10 84206809

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026