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AMIBST-AMINCT05201274

Baduanjin Sequential Therapy and Cardiac Function of AMI With Reduced EF After PCI

A study testing Baduanjin sequential therapy and Aerobic exercise in people with AMI, run by Shenyang Northern Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Acute myocardial infarction (AMI) is one of the leading causes of death around the world, with the potential for substantial morbidity and mortality. The increasing evidence indicates that exercise training has beneficial effects on LV remodelling in post-MI patients with greater benefits occurring when training… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
AMI
What is being tested?
Baduanjin sequential therapy and Aerobic exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
11 Nov 2021to 11 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute myocardial infarction undergoing primary percutaneous coronary intervention;
  • Aged 18 years or over and under 80 years;
  • 35% < LVEF < 50% and LV < 65mm;
  • With informed consents

Who cannot join

  • Severe symptomatic congestive heart failure (KILLIP cardiac function class III-IV);
  • Malignant arrhythmias (ventricular fibrillation, ventricular tachycardia, frequent multiple source ventricular premature);
  • Uncontrolled hypertension (systolic blood pressure greater than 160mmhg, diastolic blood pressure greater than 100mmhg);
  • Life-threatening diseases with limited life expectancy <6 months;
  • Inability or difficulty to exercise;
  • Participation in other clinical trials

Trial locations and contacts

1 site in 1 country.

Meili Liu, MD contact

86-18940193302

liumeili1983bl@163.com

Yaling Han, MD contact

86-24-23922184

hanyaling@163.net

China1 site, 1 recruiting

  • General Hospital of Shenyang Military Region

    Shenyang, Liaoning, 110016

    Yi Li, MD, +86-24-28897309, doctorliyi@126.com

    Recruiting

Other trials in China

About this study

Official title: Effect of Baduanjin Sequential Therapy on the Cardiac Function and Exercise Endurance in Patients With AMI and Reduced Ejection Fraction After Primary PCI

Acute myocardial infarction (AMI) is one of the leading causes of death around the world, with the potential for substantial morbidity and mortality. The increasing evidence indicates that exercise training has beneficial effects on LV remodelling in post-MI patients with greater benefits occurring when training earlier following MI, among which the earliest time for rehabilitation is one week after myocardial infarction. However, the effect of Baduanjin sequential therapy for patients after one week of AMI has yet to be assessed. Therefore, the aim of this study is to assess the impact of Baduanjin sequential therapy on cardiac and physical function in patients with AMI and reduced ejection fraction after primary PCI.

Conditions
AMI
Being tested
Baduanjin sequential therapy, Aerobic exercise
Keywords
Acute myocardial infarction, Baduanjin, Percutaneous coronary intervention, Cardiac function, Physical function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baduanjin sequential therapyBehavioural

    A detailed description of a standardized Baduanjin exercise protocol complied with the "Health Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003.

  • Aerobic exerciseBehavioural

    Participants allocated to the usual exercise control group receive a closely supervised, group-format aerobic exercise program located at home or cardiac rehabilitation centre lasting 3 months. The program is consistent with the current recommended guidelines of moderate-intensity exercises for MI.

Study groups in NCT05201274
Study groupRoleWhat they receive
Baduanjin sequential therapyExperimentalNot described
Receives: Behavioral: Baduanjin sequential therapy
Aerobic exerciseActive comparatorNot described
Receives: Behavioral: Aerobic exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricular ejection fraction (LVEF)

    The change in echocardiographic measures of left ventricular ejection fraction，(LVEF). LVEF in %.

    Measured: baseline and 3 months

Secondary outcomes (15)

  1. SF-36

    the SF-36 has 36 items grouped in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health.

    Measured: baseline and 3 months

  2. Generalized Anxiety Disorder 7-item (GAD-7)

    The Generalized Anxiety Disorder 7 (GAD-7) is a 7-item instrument used to briefly measure or assess one of the most common mental disorders.

    Measured: baseline and 3 months

  3. Patient Health Questionnaire (PHQ-9)

    The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment.

    Measured: baseline and 3 months

  4. Seattle Angina Questionnaire (SAQ)

    The Seattle Angina Questionnaire (SAQ), developed by Spertus and first reported in the literature in 1994, increasingly is being used to measure cardiac disease-specific quality of life in patients with CAD and

    Measured: baseline and 3 months

  5. Minnesota Satisfaction Questionnaire (MSQ)

    The Minnesota Satisfaction Questionnaire (MSQ) is initially designed to measure an employee's satisfaction with his or her job.

    Measured: baseline and 3 months

  6. Traditional Chinese Medicine (TCM) symptom score scale

    Traditional Chinese Medicine (TCM) symptom score scale is a score scale for evaluating patients' symptoms from the perspective of TCM. The full score is 30 points, 7-14 points are mild, 15-22 points are moderate and ≥23 points are severe.

    Measured: baseline and 3 months

  7. CPET operators-Peak VO2/kg

    Cardiopulmonary exercise testing ( CPET) is one kind of integrative evaluation of the subject's cardiopulmonary function under a certain exercise load. The information gathered during a CPET is used to calculate Peak VO2 (the highest level of oxygen consumption attained at peak exercise). (ml/kg/min)

    Measured: baseline and 3 months

  8. CPET operators-metabolic equivalent (METs)

    In cardiology, and especially when treadmill protocols are used, it is common to express the metabolic requirement for external work as the metabolic equivalent (MET). "MET" is defined as the equivalent of the resting metabolic oxygen requirement. One metabolic equivalent equals 3.5 ml/kg per minute. Exercise capacity (in METS) is a powerful predictor of mortality among men referred for exercise testing. (unit in METs)

    Measured: baseline and 3 months

  9. CPET operators-peak O2-pulse

    Another value calculated by CPET is the peak O2-pulse, which indicates how much blood one's heart can pump out with each beat (at the peak level of exercise). (ml/beat)

    Measured: baseline and 3 months

  10. 6-minute walk distance (6MWD)

    A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters)

    Measured: baseline and 3 months

  11. Exercise compliance-exercise time

    Exercise time. (in minutes)

    Measured: baseline and 3 months

  12. Exercise compliance-Exercise frequency

    Exercise frequency. (per week)

    Measured: baseline and 3 months

  13. N-terminal pro-brain natriuretic peptide (NT-pro BNP)

    N-terminal pro-brain natriuretic peptide (NT-pro BNP) in pg/ml

    Measured: baseline and 3 months

  14. LV end-diastolic volume (LVEDV)

    The change in echocardiographic measures of ventricular volumes (LV end-diastolic volume). LVEDV in ml.

    Measured: baseline and 3 months

  15. LV end-systolic volume (LVESV)

    The change in echocardiographic measures of ventricular volumes (LV end-systolic volume). LVESV in ml.

    Measured: baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2022
  2. Study start11 Nov 2021
  3. Primary completion11 Feb 2023 (estimated)
  4. Study completion11 Feb 2023 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05201274
Sponsor's protocol ID
BST-AMI
Acronym
BST-AMI
Status last verified
Jan 2022
First submitted
27 Dec 2021
Last updated
21 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Perelshtein Brezinov O, Klempfner R, Zekry SB, Goldenberg I, Kuperstein R. Prognostic value of ejection fraction in patients admitted with acute coronary syndrome: A real world study. Medicine (Baltimore). 2017 Mar;96(9):e6226. doi: 10.1097/MD.0000000000006226.

    PubMed 28248882

  • Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

    PubMed 28886621

  • Yeh RW, Sidney S, Chandra M, Sorel M, Selby JV, Go AS. Population trends in the incidence and outcomes of acute myocardial infarction. N Engl J Med. 2010 Jun 10;362(23):2155-65. doi: 10.1056/NEJMoa0908610.

    PubMed 20558366

  • Haykowsky M, Scott J, Esch B, Schopflocher D, Myers J, Paterson I, Warburton D, Jones L, Clark AM. A meta-analysis of the effects of exercise training on left ventricular remodeling following myocardial infarction: start early and go longer for greatest exercise benefits on remodeling. Trials. 2011 Apr 4;12:92. doi: 10.1186/1745-6215-12-92.

    PubMed 21463531

Questions about this trial

What is this clinical trial studying?

A study testing Baduanjin sequential therapy and Aerobic exercise in people with AMI, run by Shenyang Northern Hospital 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Meili Liu, MD (86-18940193302, liumeili1983bl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular ejection fraction (LVEF) (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05201274, which also lists 4 linked publications.

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 21 Jan 2022.

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