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

NCT07486791 | Recruiting

• 1 other identifier: SecondShanxiMU01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Conditions

ACS (Acute Coronary Syndrome); HF - Heart Failure

Outcome Measures

Primary Outcomes (8)

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

  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.

  From enrollment to the end of the 12-week treatment

• NYHA（New York Heart Association）classification of cardiac function

  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.

  From enrollment to the end of the 12-week treatment

• Left ventricular ejection fraction (LVEF) on echocardiography

  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.

  From enrollment to the end of the 12-week treatment

• C-reactive protein levels

  Unit:mg/L

  From enrollment to the end of the 12-week treatment

• ＳＦ-３６（ShortForm36HealthSurvey）

  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.

  From enrollment to the end of the 12-week treatment

• NT-proBNP（N-terminal pro-B-type natriuretic peptide）levels

  Unit:pg/ml

  From enrollment to the end of the 12-week treatment

• FMD（flow-mediated vasodilation）

  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%.

  From enrollment to the end of the 12-week treatment

• ADL（Activities of Daily Living Scale）

  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.

  From enrollment to the end of the 12-week treatment

Study Arms (2)

standard treatment and routine rehabilitation nursing guidance

PLACEBO COMPARATOR

Behavioral: standard treatment and routine rehabilitation nursing guidance

"Lying-Sitting-Standing" Sequential Baduanjin

EXPERIMENTAL

Behavioral: "Lying-Sitting-Standing" Sequential Baduanjin

Interventions

"Lying-Sitting-Standing" Sequential Baduanjin BEHAVIORAL

"Lying-Sitting-Standing" Sequential Baduanjin

"Lying-Sitting-Standing" Sequential Baduanjin

standard treatment and routine rehabilitation nursing guidance BEHAVIORAL

standard treatment and routine rehabilitation nursing guidance

standard treatment and routine rehabilitation nursing guidance

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiling Qi: lead

Study Sites (1)

Second Hospital of Shanxi Medical

Taiyuan, Shanxi, 030001, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant director physician

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 20, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (1)