ACS (Acute Coronary Syndrome), HF - Heart Failure
Conditions
Brief summary
This study investigates the effects of a sequential "lying-sitting-standing" Baduanjin intervention on patients with acute coronary syndrome complicated by heart failure. By evaluating cardiopulmonary function and quality of life through indicators such as echocardiography, NT-proBNP, 6MWT, NYHA classification, and SF-36, we aim to compare its efficacy with conventional treatment. The objective is to provide new insights for early cardiac rehabilitation strategies in patients with acute coronary syndrome complicated by heart failure
Interventions
BEHAVIORALstandard treatment and routine rehabilitation nursing guidance
standard treatment and routine rehabilitation nursing guidance
BEHAVIORAL"Lying-Sitting-Standing" Sequential Baduanjin
"Lying-Sitting-Standing" Sequential Baduanjin
Sponsors
Xiling Qi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients meeting the diagnostic criteria for ACS (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction) * Complicated by heart failure during hospitalization * Age ≤ 85 years * Muscle strength ≥ grade 3 * No history of mental illness, conscious and able to cooperate independently with this study * Voluntarily participate in this study and sign the informed consent form
Exclusion criteria
* Patients with persistent heart failure symptoms or NYHA functional class IV despite optimal pharmacological therapy; * Patients with contraindications to cardiac rehabilitation, such as uncontrolled hypertension, uncontrolled arrhythmias, or hemodynamic instability; * Patients with untreated structural heart disease, such as heart failure caused by valvular heart disease or congenital heart disease; * Patients in the acute phase of various diseases, such as severe infection, deep vein thrombosis, or severe hepatic or renal failure; * Patients with disabilities, bone or joint diseases, or neurological disorders that preclude participation in Baduanjin exercises; * Patients with a life expectancy of less than one year; * Patients currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients were stratified based on their 6-minute walk test distance | From enrollment to the end of the 12-week treatment | The 6-minute walk test is an objective indicator for evaluating exercise tolerance in patients with heart failure, representing the total distance a patient can walk in 6 minutes. The results are categorized into four grades based on the distance covered: \<300 m, 300-374.9 m, 375-449.9 m, and ≥450 m. |
| NYHA（New York Heart Association）classification of cardiac function | From enrollment to the end of the 12-week treatment | The New York Heart Association (NYHA) Functional Classification, proposed in 1928 and still in use today, categorizes patients into classes Ⅰ through Ⅳ, with class Ⅰ representing the best condition and class Ⅳ the worst. |
| Left ventricular ejection fraction (LVEF) on echocardiography | From enrollment to the end of the 12-week treatment | Ejection fraction is a ratio reflecting the efficiency of cardiac pumping, defined as the percentage of blood volume pumped out by the left ventricle during each contraction (stroke volume, SV) relative to its end-diastolic volume (EDV). It is measured using the Simpson's method on echocardiography. |
| C-reactive protein levels | From enrollment to the end of the 12-week treatment | Unit:mg/L |
| ＳＦ-３６（ShortForm36HealthSurvey） | From enrollment to the end of the 12-week treatment | The SF-36 is a generic scale developed by the Boston Health Research Institute in the United States in 1988, based on the Medical Outcomes Study Short-Form (MOS SF) originally devised by Stewart et al. It is used to assess health-related quality of life in populations. The scale contains 36 items and comprehensively evaluates health-related quality of life across eight dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Scores for each dimension are converted using specific formulas to a scale of 0 to 100, with higher scores indicating better health status. |
| NT-proBNP（N-terminal pro-B-type natriuretic peptide）levels | From enrollment to the end of the 12-week treatment | Unit:pg/ml |
| FMD（flow-mediated vasodilation） | From enrollment to the end of the 12-week treatment | Flow-mediated dilation (FMD) is a non-invasive method for assessing vascular endothelial function, based on the mechanism by which endothelial cells respond to changes in shear stress. It uses high-frequency ultrasound (7-12 MHz) to measure the inner diameter of the brachial artery at rest, record the peak blood flow velocity and changes in vessel diameter following reactive hyperemia, and calculate the maximum vasodilatory response. The calculation formula is: FMD = \[(post-reactive diameter - baseline diameter) / baseline diameter\] × 100%. |
| ADL（Activities of Daily Living Scale） | From enrollment to the end of the 12-week treatment | The ADL , which stands for the Activities of Daily Living Scale, was developed by Lawton and Brody in 1969. It is primarily used to assess an individual's ability to perform daily activities. The basic activities of daily living evaluated by this scale include ten items: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, bed-to-chair transfer, walking on level ground, and stair climbing. The total score is 100 points. Based on the score, functional status is classified into four levels: ≤40 indicates severe dependence; 41-60 indicates moderate dependence; 61-99 indicates mild dependence; and 100 indicates independence. |
Countries
China
Outcome results
None listed