Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)

Not Applicable

Recruiting

• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure
• Interventions: Behavioral: BESMILE-HF program; Drug: Usual medications

• Registration Number: NCT03180320
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-08
• Study Start: 2018-10-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BESMILE-HF group	BESMILE-HF program	Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines. In addition, patients will receive the BESMILE-HF program.
BESMILE-HF group	Usual medications	Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines. In addition, patients will receive the BESMILE-HF program.
Control	Usual medications	Patients in the control group will receive only the usual medications, since patients typically do not receive exercise-based cardiac rehabilitation in this kind of setting.

Primary Outcome Measures

Name	Time	Method
Change from baseline peak VO2 (ml/kg/min) at 12 week	Baseline, 12 week	Peak oxygen uptake
Change from baseline MLHFQ at 12 week	Baseline,12 week	Minnesota Living with Heart Failure Questionnaire

Secondary Outcome Measures

Name	Time	Method
hsCRP	Baseline, 12 week	Inflammatory indicator from blood sample
Total score of Patient Health Questionnaire-9 (PHQ-9)	Baseline, 4 week, 8 week, 12 week	The total score ranges from 0-27, the higher scores indicates worse outcomes
6MWT	Baseline, 4 week, 8 week, 12 week	6-minute walking test
TGUG	Baseline, 4 week, 8 week, 12 week	Timed get-up and-go
GRC	Baseline, 4 week, 8 week, 12 week	Global Rating of Change
LVEF (%)	Baseline, 12 week	Parameters from echocardiography: Left ventricular systolic function
Global longitudinal strain 2D (%)	Baseline, 12 week	Parameters from echocardiography: Left ventricular systolic function
NT pro-BNP	Baseline, 12 week	Prognostic biomarker from blood sample
LVEDD (mm)	Baseline, 12 week	Parameters from echocardiography: Dimensions and volumes
LA (mm)	Baseline, 12 week	Parameters from echocardiography: Dimensions and volumes
E/A ratio	Baseline, 12 week	Parameters from echocardiography: Left ventricular diastolic function
SEE-C	Baseline, 4 week, 8 week, 12 week	Exercise Self-efficacy
MLHFQ	Baseline, 4 week, 8 week, 12 week	Minnesota Living with Heart Failure Questionnaire
EQ-5D	Baseline, 4 week, 8 week, 12 week	General quality of life
Total score of General Anxiety Disorder-7 (GAD-7)	Baseline, 4 week, 8 week, 12 week	The total score ranges from 0-21, the higher scores indicates worse outcomes
Number of patients who has a increand 6% PeakVO2	Baseline, 12 week	Number of patients who has a increand 6% PeakVO2

Trial Locations

Locations (1)

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China