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

April 29, 2026 updated by: Xiling Qi
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • Second Hospital of Shanxi Medical
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: standard treatment and routine rehabilitation nursing guidance
Behavioral: standard treatment and routine rehabilitation nursing guidance
standard treatment and routine rehabilitation nursing guidance
Experimental: "Lying-Sitting-Standing" Sequential Baduanjin
Behavioral: "Lying-Sitting-Standing" Sequential Baduanjin
"Lying-Sitting-Standing" Sequential Baduanjin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients were stratified based on their 6-minute walk test distance
Time Frame: 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.
From enrollment to the end of the 12-week treatment
NYHA（New York Heart Association）classification of cardiac function
Time Frame: 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.
From enrollment to the end of the 12-week treatment
Left ventricular ejection fraction (LVEF) on echocardiography
Time Frame: 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.
From enrollment to the end of the 12-week treatment
C-reactive protein levels
Time Frame: From enrollment to the end of the 12-week treatment
Unit:mg/L
From enrollment to the end of the 12-week treatment
ＳＦ-３６（ShortForm36HealthSurvey）
Time Frame: 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.
From enrollment to the end of the 12-week treatment
NT-proBNP（N-terminal pro-B-type natriuretic peptide）levels
Time Frame: From enrollment to the end of the 12-week treatment
Unit:pg/ml
From enrollment to the end of the 12-week treatment
FMD（flow-mediated vasodilation）
Time Frame: 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%.
From enrollment to the end of the 12-week treatment
ADL（Activities of Daily Living Scale）
Time Frame: 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.
From enrollment to the end of the 12-week treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiling Qi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SecondShanxiMU01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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