Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120, China
Location status: Recruiting
Location contact
Lu Weihui
CONTACT
NCT Number: NCT03180320
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510120, China
Location status: Recruiting
Lu Weihui
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The following activities will be conducted as part of the BESMILE-HF program:
Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.
Time frame: Baseline, 12 week
Peak oxygen uptake
Time frame: Baseline,12 week
Minnesota Living with Heart Failure Questionnaire
Time frame: Baseline, 4 week, 8 week, 12 week
6-minute walking test
Time frame: Baseline, 4 week, 8 week, 12 week
Timed get-up and-go
Time frame: Baseline, 4 week, 8 week, 12 week
Exercise Self-efficacy
Time frame: Baseline, 4 week, 8 week, 12 week
Minnesota Living with Heart Failure Questionnaire
Time frame: Baseline, 4 week, 8 week, 12 week
General quality of life
Time frame: Baseline, 4 week, 8 week, 12 week
Global Rating of Change
Time frame: Baseline, 12 week
Parameters from echocardiography: Dimensions and volumes
Time frame: Baseline, 12 week
Parameters from echocardiography: Dimensions and volumes
Time frame: Baseline, 12 week
Parameters from echocardiography: Left ventricular systolic function
Time frame: Baseline, 12 week
Parameters from echocardiography: Left ventricular systolic function
Time frame: Baseline, 12 week
Parameters from echocardiography: Left ventricular diastolic function
Time frame: Baseline, 12 week
Prognostic biomarker from blood sample
Time frame: Baseline, 12 week
Inflammatory indicator from blood sample
Time frame: Baseline, 4 week, 8 week, 12 week
The total score ranges from 0-27, the higher scores indicates worse outcomes
Time frame: Baseline, 4 week, 8 week, 12 week
The total score ranges from 0-21, the higher scores indicates worse outcomes
Time frame: Baseline, 12 week
Number of patients who has a increand 6% PeakVO2
Time frame: Baseline, 4 week, 8 week, 12 week
International Physical Activity Questionnaire
Time frame: Through study completion, an average of 12 weeks
Safety assessment
Time frame: Through study completion, an average of 12 weeks
Major acute cardiac events
Time frame: Baseline, 12 week
Parameters from Holter 24-hour ECG
Time frame: Baseline, 12 week
Parameters from Holter 24-hour ECG
Time frame: Through study completion, an average of 12 weeks
All-caused mortality
Time frame: Through study completion, an average of 12 weeks
All-caused hospitalization
Time frame: Through study completion, an average of 12 weeks
Heart failure hospitalizaiton
Contact information is provided by the study sponsor or research team.
Guangdong Provincial Hospital of Traditional Chinese Medicine
Other
Effect of an Exercise-based Cardiac Rehabilitation Program 'Baduanjin-eight-silken-movement With Self-efficacy Building' for Patients With Chronic Heart Failure in Guangzhou, China (BESMILE-HF Study)
Acronym: BESMILE-HF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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