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临床试验/NCT07486791
NCT07486791招募中不适用

A Clinical Study on the Effect of Cardiopulmonary Function and Quality of Life in Patients With Acute Coronary Syndrome Complicated by Heart Failure by "Lying-Sitting-Standing" Sequential Baduanjin

Xiling Qi1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2026年3月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
65
试验地点
1
主要终点
C-reactive protein levels

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

standard treatment and routine rehabilitation nursing guidance

Placebo Comparator

干预措施: standard treatment and routine rehabilitation nursing guidance (Behavioral)

"Lying-Sitting-Standing" Sequential Baduanjin

Experimental

干预措施: "Lying-Sitting-Standing" Sequential Baduanjin (Behavioral)

结局指标

主要结局

C-reactive protein levels

时间窗: From enrollment to the end of the 12-week treatment

Unit:mg/L

Patients were stratified based on their 6-minute walk test distance

时间窗: 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

时间窗: 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

时间窗: 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.

SF-36(ShortForm36HealthSurvey)

时间窗: 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

时间窗: From enrollment to the end of the 12-week treatment

Unit:pg/ml

FMD(flow-mediated vasodilation)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Xiling Qi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiling Qi

assistant director physician

Second Hospital of Shanxi Medical University

研究点 (1)

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