coronary heart disease
Conditions
Interventions
Traditional Chinese Medicine Constitution Prescription+Form Spirit Harmony Rehabilitation Group:Qike Shuxin Formula Granules+Shape Spirit Harmony Rehabilitation Prescription
Traditional Chinese Medicine Constitution Prescription+Health Education Group:Qike Shuxin Formula Granules+Health Education
Form Spirit Harmony Rehabilitation Group:Placebo+physical and mental rehabilitation prescription
the health education group:Placebo+health education
Sponsors
Xiyuan hospital of CACMS
Eligibility
Sex/Gender
All
Age
65 Years to 79 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for coronary heart disease: confirmed by coronary angiography or coronary CTA that at least one main coronary artery has a stenosis degree of = 50%, or has a history of old myocardial infarction, or has undergone PCI or CABG surgery for more than 1 month; (2) Age between 65 and 79 years old, regardless of gender; (3) Those who meet the diagnostic criteria for both Qi deficiency, blood stasis, and liver qi stagnation in traditional Chinese medicine; (4) Individuals who meet the risk stratification of moderate to low-risk for coronary heart disease cardiac exercise rehabilitation; (5)LVEF=40%; (6) Canadian Angina Pectoris Classification I-III; (7) I have not previously practiced systematic Eight dan Brocade; (8) Informed consent and voluntary participation in this project.
Exclusion criteria
Exclusion criteria: (1) Patients with severe congestive heart failure, uncontrolled hypertension (resting blood pressure = 160/100mmHg), uncorrected severe bradycardia or tachyarrhythmia, severe heart valve disease, cardiomyopathy, active myocarditis or pericarditis; (2) Various diseases in the acute phase or severe functional failure phase, such as acute infection, acute cerebrovascular disease, gastrointestinal bleeding, respiratory failure, liver dysfunction, renal failure, etc; (3) Patients with malignant tumors or serious primary diseases in the blood system have an expected life expectancy of less than 1 year; (4) Those who have suffered from major illnesses or undergone major surgeries within the past six months and have not yet recovered; (5) Unable to cooperate in completing exercise training or evaluation, such as comorbidities of neurological disorders affecting movement such as cerebral hemorrhage, stroke, epilepsy, Parkinson's disease, etc; Or there may be serious muscle, bone, joint diseases or other contraindications to exercise; Or severe visual and auditory impairments that prevent normal communication; Or combined with serious mental and psychological disorders; (6) Individuals who have regularly engaged in daily physical exercise in the past three months; (7) Participants in other clinical trials in the past 3 months; (8) Individuals who are allergic to known components of the investigational drug; (9) The researcher believes that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in metabolic equivalents measured by Cardiopulmonary Exercise Test (CPET) after 3 months of treatment compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Record the incidence of major adverse cardiovascular events in each group during the 12 week treatment period and 24 week follow-up period: cardiovascular death, non fatal myocardial infarction, emergency revascularization, readmission due to unstable angina or heart failure, stroke, and other thrombotic events;;Changes in other indicators (peak kilogram oxygen uptake, oxygen pulse, etc.) measured by Cardiopulmonary Exercise Test (CPET) from baseline to 12 weeks of treatment;;Seattle Angina Questionnaire(SAQ);Traditional Chinese Medicine Syndrome Integral Scale(TCMSS);Fried Frailty Assessment Scale (FRAIL);European Five Dimensional Quality of Life Scale (EQ-5D-5L);Activities of Daily Living Scale (ADL);Anxiety and Depression Rating Scale (PHQ-9, GAD-7);LVEF and LVEDd measured by cardiac ultrasound; | — |
Countries
China
Contacts
Public ContactHuanna
Xiyuan hospital of CACMS
Outcome results
None listed