NCT03180320 Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)
| NCT ID | NCT03180320 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangdong Provincial Hospital of Traditional Chinese Medicine |
| Condition | Heart Failure NYHA Class II |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2018-10-22 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2018-10-22 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic heart failure (CHF) is a major and growing public health problem and poses economic burden on the society. There is a need for a safe, equipment-free, low-cost, and easily implemented exercise-based cardiac rehabilitation program for CHF patients in China. Baduanjin exercise, translated as 'eight silken movements', is one of the most common forms of traditional Chinese exercise and it could have value to be integrated into a exercise-based cardiac rehabilitation program for CHF patients, together with education, evaluation and consultancy. Accordingly, the BESMILE-HF program applying the Baduanjin exercise as the central component, has been developed in Guangdong Provincial Hospital of Chinese Medicine which is one of the largest hospitals of Chinese medicine in China. This project is to evaluate the efficacy and acceptability of BESMILE-HF program in patients with CHF in China, and it will be based on a randomized controlled trial and a qualitative study.
Eligibility Criteria
Inclusion Criteria: 1. aged 18 years or above 2. diagnosed with chronic heart failure 3. clinically stable as defined as symptoms and signs that have remained generally unchanged for at least 1 month 4. NYHA functional class II or III Exclusion Criteria: 1. patients who have contraindications to cardiopulmonary test 2. patients who have contraindications to exercise training 3. Patients who have serious acute or chronic organic disease or mental disorders 4. history of cardiac surgery, cardiac resynchronization therapy, or intracardiac defibrillation within the previous 3 months; 5. history of cardiac arrest within 1 year; 6. history of peripartum cardiomyopathy, hyperthyroid heart disease, primary pulmonary hypertension; 7. inability to perform a bicycle stress test; 8. severe cognitive dysfunction precluding informed consent or understanding of exercise concepts; 9. current regular Baduanjin or current participation in a conventional cardiac rehabilitation program 10. current participation in another trial.
Contact & Investigator
Weihui Lu
PRINCIPAL INVESTIGATOR
Guangdong Provincial Hospital of Traditional Chinese Medicine
Frequently Asked Questions
Who can join the NCT03180320 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure NYHA Class II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03180320 currently recruiting?
Yes, NCT03180320 is actively recruiting participants. Contact the research team at weihui.lu@163.com for enrollment information.
Where is the NCT03180320 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT03180320 clinical trial?
NCT03180320 is sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine. The principal investigator is Weihui Lu at Guangdong Provincial Hospital of Traditional Chinese Medicine. The trial plans to enroll 150 participants.
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