ACS (Acute Coronary Syndrome)NCT07486791
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
A study testing standard treatment and routine rehabilitation nursing guidance and "Lying-Sitting-Standing" Sequential Baduanjin in people with ACS (Acute Coronary Syndrome) and HF - Heart Failure, run by Xiling Qi at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- ACS (Acute Coronary Syndrome), HF - Heart Failure
- What is being tested?
- standard treatment and routine rehabilitation nursing guidance and "Lying-Sitting-Standing" Sequential Baduanjin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Hospital of Shanxi Medical
Taiyuan, Shanxi, 030001
xiling Qi, 86-13903412295, stick@163.com
About this study
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
- Being tested
- standard treatment and routine rehabilitation nursing guidance, "Lying-Sitting-Standing" Sequential Baduanjin
- Medical subject headings
- Acute Coronary Syndrome, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard treatment and routine rehabilitation nursing guidanceBehavioural
standard treatment and routine rehabilitation nursing guidance
"Lying-Sitting-Standing" Sequential BaduanjinBehavioural
"Lying-Sitting-Standing" Sequential Baduanjin
| Study group | Role | What they receive |
|---|---|---|
| standard treatment and routine rehabilitation nursing guidance | Placebo comparator | Not described Receives: Behavioral: standard treatment and routine rehabilitation nursing guidance |
| "Lying-Sitting-Standing" Sequential Baduanjin | Experimental | Not described Receives: Behavioral: "Lying-Sitting-Standing" Sequential Baduanjin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the 12-week treatment
C-reactive protein levels
Unit:mg/L
Measured: 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.
Measured: From enrollment to the end of the 12-week treatment
NT-proBNP（N-terminal pro-B-type natriuretic peptide）levels
Unit:pg/ml
Measured: 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%.
Measured: 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.
Measured: From enrollment to the end of the 12-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start10 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACS (Acute Coronary Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiling Qi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiling Qi, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486791
- Sponsor's protocol ID
- SecondShanxiMU01
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07486791
- Acronym / sponsor ID
- SecondShanxiMU01
- Conditions
- ACS (Acute Coronary Syndrome), HF - Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Xiling QiUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard treatment and routine rehabilitation nursing guidancestandard treatment and routine rehabilitation nursing guidance | Behavioural | standard treatment and routine rehabilitation nursing guidance |
| "Lying-Sitting-Standing" Sequential Baduanjin"Lying-Sitting-Standing" Sequential Baduanjin | Behavioural | "Lying-Sitting-Standing" Sequential Baduanjin |
Primary outcome
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.
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.
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.
C-reactive protein levels
Time frame: From enrollment to the end of the 12-week treatment
Unit:mg/L
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.
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
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%.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard treatment and routine rehabilitation nursing guidance and "Lying-Sitting-Standing" Sequential Baduanjin in people with ACS (Acute Coronary Syndrome) and HF - Heart Failure, run by Xiling Qi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients were stratified based on their 6-minute walk test distance (time frame: From enrollment to the end of the 12-week treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.