Baduanjin Intervention in Clinical Studies After Coronary Revascularization Surgery
19. mai 2026 oppdatert av: Liu Qiang
- To evaluate the efficacy and safety of the Baduanjin exercise programme in patients following coronary revascularisation surgery;
- To develop a traditional Chinese medicine (TCM) rehabilitation protocol and evaluation system for patients following coronary revascularisation surgery;
- To clarify the advantages of TCM rehabilitation in the post-operative management of coronary revascularisation surgery and to provide high-level evidence-based medical evidence for TCM rehabilitation protocols.
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert beskrivelse
Patients who had undergone coronary revascularisation were selected as study subjects and divided into an intervention group (standard Western medical treatment + Baduanjin) and a control group (standard Western medical treatment + aerobic exercise). The intervention lasted 12 weeks, with follow-up assessments conducted at baseline (on the day of enrolment), 6 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks. The incidence of major adverse cardiovascular events was used as the primary efficacy endpoint, secondary efficacy endpoints included Traditional Chinese Medicine syndrome scores, echocardiography, Holter monitoring, the Minnesota Quality of Life Questionnaire, cardiac enzymes, blood lipids and blood glucose; safety endpoints comprised vital signs, complete blood count, liver and kidney function, and other adverse reactions and events.
Translated with DeepL.com (free version)
Studietype
Intervensjonell
Registrering (Antatt)
310
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Liu Qiang, PhD
- Telefonnummer: +86 13588121905
- E-post: 19981011@zcmu.edu.cn
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Participants who meet the diagnostic criteria for coronary heart disease
- Participants who underwent successful percutaneous coronary intervention
- Participants aged between 18 and 80
- Participants of any gender
- Participants who have signed an informed consent form
Exclusion Criteria:
- Subjects with severe hepatic or renal impairment
- subjects with severe electrolyte disturbances
- subjects with severe haematological disorders or malignant tumours
- pregnant or breastfeeding women
- subjects with psychiatric disorders
- subjects with cognitive impairment (e.g. dementia, post-stroke cognitive impairment) that prevents them from understanding or carrying out exercise instructions
- Subjects scheduled to undergo repeat revascularisation surgery in the near future
- Subjects with other severe cardiovascular diseases such as uncontrolled hypertension, angina pectoris, rapid arrhythmias, high-degree or complete atrioventricular block (without a pacemaker), acute severe aortic stenosis, decompensated heart failure (NYHA Class IV), deep vein thrombosis, obstructive hypertrophic cardiomyopathy, acute pericarditis or myocarditis, acute endocarditis, or acute aortic dissection
- Participants with acute pulmonary embolism or chronic lung disease accompanied by symptoms of dyspnoea (occurring at rest or with minimal exertion)
- Subjects with impaired limb mobility or who are unable to move independently;
- Subjects with Shy-Drager syndrome
- Subjects who have participated in a clinical trial involving other drugs or exercise interventions within the past month
- Subjects deemed by the investigator to have other conditions rendering them unsuitable for participation in the trial
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental Group
Standardized Western medical treatment + Standardized Baduanjin rehabilitation training.
Standardised Baduanjin training was conducted under the supervision of a qualified doctor or physiotherapist.
Participants trained four times a week, performing the routine twice at each session.
Progress was monitored and guidance provided through the creation of a WeChat group and the distribution of video materials.
Participants received weekly guidance, either online or in person, and uploaded videos of their training sessions.
Throughout the study, all sessions were regularly monitored and feedback was provided to ensure correct instruction.
|
Standardised Baduanjin training was conducted under the supervision of a qualified doctor or physiotherapist.
Participants trained four times a week, performing the routine twice at each session.
Progress was monitored and guidance provided through the creation of a WeChat group and the distribution of video materials.
Participants received weekly guidance, either online or in person, and uploaded videos of their training sessions.
Throughout the study, all sessions were regularly monitored and feedback was provided to ensure correct instruction.
|
|
Aktiv komparator: Control Group
Standardized Western medical treatment + Aerobic exercise training.
Aerobic exercise training included climbing stairs, jogging, brisk walking and cycling.
The exercise intensity for the aerobic exercise group was monitored, with maximum heart rate estimated as 208 minus (0.7 × age).
Participants received weekly guidance, either online or in person, and uploaded videos of their training sessions.
Throughout the study, all sessions were regularly monitored and feedback was provided to ensure correct guidance.
|
Aerobic exercise training included climbing stairs, jogging, brisk walking and cycling.
The exercise intensity for the aerobic exercise group was monitored, with maximum heart rate estimated as 208 minus (0.7 × age).
Participants received weekly guidance, either online or in person, and uploaded videos of their training sessions.
Throughout the study, all sessions were regularly monitored and feedback was provided to ensure correct guidance.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of major cardiovascular adverse events
Tidsramme: From enrolment to 48 weeks of follow-up
|
Using medical record forms and clinical diagnostic criteria, assess the number of cases of the following cardiovascular adverse events: all-cause mortality, subacute in-stent thrombosis, perioperative myocardial infarction, recurrent myocardial infarction, recurrent unstable angina, repeat revascularisation, and readmission for angina or heart failure; and record the date of occurrence, basis for diagnosis, management measures, outcome (recovery/persistence/worsening/death), causality (definitely related/probably related/probably unrelated/definitely unrelated/cannot be determined) and the impact on the study (whether the patient withdrew or the study was unblinded).
Units: cases or categorical variables.
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From enrolment to 48 weeks of follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
TCM Syndrome Score
Tidsramme: From enrolment to 48 weeks of follow-up
|
Using the 'Scoring Table for Syndromes in Traditional Chinese Medicine', the following symptoms were assessed: chest pain, chest tightness, palpitations, shortness of breath, exacerbation on exposure to cold, mental fatigue and physical weakness, spontaneous sweating, reluctance to speak, obesity, epigastric fullness and loss of appetite, gooseflesh, a dark purple complexion or lips, a sensation of heaviness in the head as if wrapped in a cloth, coughing up phlegm or wheezing in the throat, aversion to cold and cold limbs, hot flushes and night sweats, dry mouth and throat, pale conjunctiva of the eyelids, severe bitter taste in the mouth, and emotional depression or frequent sighing.
These 20 symptoms were each scored on a scale of 0-3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe); simultaneously record bowel movements and urination, tongue quality, tongue shape, tongue coating, sublingual veins, pulse characteristics, and the qualitative classification of primary syndromes.
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From enrolment to 48 weeks of follow-up
|
|
Echocardiogram
Tidsramme: Enrollment and 12-week follow-up
|
This study used echocardiography (ultrasound diagnostic equipment) to assess the following parameters: left ventricular ejection fraction (LVEF, %); left ventricular short-axis fraction of shortening (FS, %); left ventricular end-diastolic diameter (LVEDD, unit: mm), left ventricular end-systolic diameter (LVESD, unit: mm), left ventricular posterior wall thickness (LVPW, unit: mm), and interventricular septal thickness (IVS, unit: mm); simultaneously assess the following left ventricular diastolic function parameters: E/A ratio (unit: none, i.e. ratio) and mean E/e' ratio (unit: none) ; and record the overall assessment and conclusions, including major findings such as segmental wall motion abnormalities and reduced left ventricular diastolic function (qualitative description), as well as comparisons with previous examinations (newly developed/improved compared to previous findings/worsened compared to previous findings/no change/no comparable data available).
|
Enrollment and 12-week follow-up
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Dynamic Electrocardiogram
Tidsramme: Enrollment and 12-week follow-up
|
This study assessed the following parameters using 24-hour Holter monitoring: mean, maximum and minimum heart rates and durations; total number of atrial premature beats (P' wave morphology), number of atrial tachycardia episodes, duration of atrial fibrillation/flutter (P wave replaced by f/F waves); total number of ventricular premature beats (QRS complex width ≥120 ms, without preceding P wave), number of paired ventricular premature beats and ventricular tachycardia episodes; longest RR interval and asystole/conduction block; amplitude and duration of ST-segment depression events (measured 80 ms after the J point); heart rate variability (SDNN); and P-wave width, PR interval, QRS width, QT interval and QTc interval (Bazett formula) measured during sinus rhythm.
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Enrollment and 12-week follow-up
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Minnesota Quality of Life Scale
Tidsramme: From enrolment to 48 weeks of follow-up
|
The standardised Minnesota Heart Failure Quality of Life Questionnaire was completed by the patients themselves or with the assistance of the investigators to quantitatively assess their quality of life.
The Minnesota Health-Related Quality of Life Questionnaire (MLHFQ) is a standardised tool used to quantify the overall impact of heart failure on patients' physical, emotional and social functioning.
The total score ranges from 0 to 105; a higher score indicates poorer quality of life, whilst a lower score indicates better health-related quality of life.
A total score below 24 is considered an indicator of good quality of life.
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From enrolment to 48 weeks of follow-up
|
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Cardiac enzymes
Tidsramme: Enrollment and 12-week follow-up
|
Peripheral venous blood samples were collected from patients at each follow-up visit and analysed biochemically by the central laboratory to record levels of cardiac enzymes, including creatine kinase isoenzymes.
|
Enrollment and 12-week follow-up
|
|
blood lipids
Tidsramme: Enrollment and 12-week follow-up
|
Blood samples were collected from patients' peripheral veins at each visit and sent to the central laboratory for biochemical analysis to determine levels of four lipid parameters, including total cholesterol.
|
Enrollment and 12-week follow-up
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Fasting blood glucose
Tidsramme: Enrollment and 12-week follow-up
|
Peripheral venous blood samples were collected from patients at each visit, and biochemical analyses were carried out by the central laboratory, with the results recorded.
|
Enrollment and 12-week follow-up
|
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Peripheral venous blood samples were collected from patients at each visit, and biochemical analyses were carried out by the central laboratory, with the results recorded.
Tidsramme: Enrollment and 12-week follow-up
|
Peripheral venous blood samples were collected from patients at each visit, and biochemical analyses were carried out by the central laboratory, with the results recorded.
|
Enrollment and 12-week follow-up
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Red blood cell count
Tidsramme: Enrollment and 12-week follow-up
|
As part of the objective assessment, blood samples were taken for a complete blood count at the time points specified in the study.
|
Enrollment and 12-week follow-up
|
|
Haemoglobin concentration
Tidsramme: Enrollment and 12-week follow-up
|
Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.
|
Enrollment and 12-week follow-up
|
|
White blood cell count
Tidsramme: Enrollment and 12-week follow-up
|
Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.
|
Enrollment and 12-week follow-up
|
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Platelet count
Tidsramme: Enrollment and 12-week follow-up
|
Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.
|
Enrollment and 12-week follow-up
|
|
Haematocrit
Tidsramme: Enrollment and 12-week follow-up
|
Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.
|
Enrollment and 12-week follow-up
|
|
Alanine transaminase
Tidsramme: Enrollment and 12-week follow-up
|
As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
|
Enrollment and 12-week follow-up
|
|
Aspartate transaminase
Tidsramme: Enrollment and 12-week follow-up
|
As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
|
Enrollment and 12-week follow-up
|
|
Alkaline phosphatase
Tidsramme: Enrollment and 12-week follow-up
|
As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
|
Enrollment and 12-week follow-up
|
|
Potassium
Tidsramme: Enrollment and 12-week follow-up
|
As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
|
Enrollment and 12-week follow-up
|
|
Sodium
Tidsramme: Enrollment and 12-week follow-up
|
As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
|
Enrollment and 12-week follow-up
|
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Total bilirubin
Tidsramme: Enrollment and 12-week follow-up
|
As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
|
Enrollment and 12-week follow-up
|
|
Blood urea nitrogen
Tidsramme: Enrollment and 12-week follow-up
|
As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
|
Enrollment and 12-week follow-up
|
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Creatinine
Tidsramme: Enrollment and 12-week follow-up
|
As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
|
Enrollment and 12-week follow-up
|
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Uric acid
Tidsramme: Enrollment and 12-week follow-up
|
As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
|
Enrollment and 12-week follow-up
|
|
Homocysteine
Tidsramme: Enrollment and 12-week follow-up
|
As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.
|
Enrollment and 12-week follow-up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
30. juni 2028
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
12. mai 2026
Først innsendt som oppfylte QC-kriteriene
19. mai 2026
Først lagt ut (Faktiske)
27. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ZSLL-KY-2026-026-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Firstly, the informed consent forms obtained from participants prior to the commencement of the study did not include any provisions authorising the open sharing of de-identified individual data on public platforms.
Out of strict respect for participants' right to privacy and the scope of their informed consent, it is not appropriate to make the data publicly available.
Secondly, as this study involves multi-centre collaboration, the ownership of data and the mechanisms for data sharing across the various sub-centres have not yet been uniformly clarified in the collaboration agreement.
Furthermore, the individualised data collected in this trial-such as Traditional Chinese Medicine (TCM) syndrome scores and tongue and pulse characteristics-lacks recognised public data-sharing standards for its de-identification and standardisation.
Direct disclosure could lead to the data being misinterpreted or misused.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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