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A randomized controlled trial of online home-based baduanjin to reduce composite cardiovascular events in chronic heart failure

A randomized controlled trial of online home-based baduanjin to reduce composite cardiovascular events in chronic heart failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001068
Enrollment
Unknown
Registered
2025-05-28
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic heart failure

Interventions

Test group:Standard basic treatment for heart failure routine management and a comprehensive intervention plan for online home-based Baduanjin cardiac rehabilitation.
Control group:Standard basic treatment and routine management for heart failure

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-80 years regardless of gender; (2) With a history of chronic heart failure for more than 3 months or clinical symptoms of heart failure for more than 3 months meeting the diagnostic criteria for chronic heart failure (the diagnosis of chronic heart failure refers to the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024" issued by the Cardiology Branch of the Chinese Medical Association and refers to the heart failure-related guidelines of the American Heart Association and the European Society of Cardiology); (3) Serum NT-proBNP level = 450 pg/ml; (4) NYHA functional class II-III including those who had been diagnosed as class IV within 2 weeks prior to enrollment; (5) Patients who have received at least 2 weeks of standardized pharmacological therapy recommended by guidelines without adjustment of drug dosage or intravenous therapy; standardized pharmacological therapy includes: angiotensin-converting enzyme inhibitors (ACEI) angiotensin receptor blockers (ARB) angiotensin receptor neprilysin inhibitors (ARNI) ß-blockers mineralocorticoid receptor antagonists SGLT2 inhibitors and soluble guanylate cyclase stimulators (unless contraindicated or intolerant optimal therapeutic doses should be achieved); (6) Willing to participate and understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with unstable structural valvular heart disease moderate to severe aortic stenosis peripartum cardiomyopathy new-onset atrial fibrillation/flutter uncontrolled complex arrhythmias acute rapid arrhythmias acute myocardial infarction etc. who meet the absolute and relative contraindications for cardiopulmonary exercise testing; patients with severe osteoporosis and other conditions that are not suitable for exercise. (2) Patients with a history of cardiac surgery cardiac resynchronization therapy intra-cardiac defibrillation or combined device implantation within the past 3 months. (3) Patients with severe primary diseases of the liver kidneys hematopoietic system etc. abnormal renal function liver transaminases and alkaline phosphatase levels exceeding 3 times the upper limit of normal serum creatinine > 2 mg/dl (176.82 umol/L) serum potassium > 5.5 mmol/L; patients with tumors severe neuroendocrine diseases and psychiatric disorders. (4) Patients with unstable vital signs (blood pressure greater than 180/110 mmHg or less than 90/60 mmHg resting heart rate greater than 100 beats per minute). (5) Patients with a history of cardiac arrest within the past year. (6) Patients with severe cognitive impairment limb disabilities and inability to take care of themselves who cannot cooperate with rehabilitation exercises. (7) Patients with a life expectancy of less than 12 months. (8) Pregnant or breastfeeding women and those who plan to become pregnant in the near future. (9) Patients who cannot comply with the study protocol for follow-up visits and cannot complete the exercise rehabilitation on time. (10) Patients who have participated in other clinical trials within the past month.

Design outcomes

Primary

MeasureTime frame
1-year composite cardiovascular events;

Secondary

MeasureTime frame
Cardiovascular mortality rate for six months;NYHA Classification of Heart Function;All-cause mortality rate within one year;The incidence of composite cardiovascular events within six months;Incidence of adverse cardiovascular events within one year;Kansas City Cardiomyopathy Questionnaire (KCCQ);Patient Health Questionnaire (PHQ) for depression screening;The incidence of heart failure readmission within 1 year;Generalized Anxiety Disorder scale (GAD) for anxiety screening;NT-proBNP hs-CRP and lipid profile (4 items);Cardiovascular mortality rate for 1 year;The incidence of heart failure readmission within six months;6-Minute Walk Distance;Cardiac Ultrasound: LVEF (measured using the biplane Simpson's method) LVEDD etc;EuroQol-5 Dimensions (EQ-5D) for general quality of life assessment;

Countries

China

Contacts

Public ContactHuayang Cai

Guangdong Provincial Hospital of Chinese Medicine

caihuayang@gzucm.edu.cn13570906008

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026