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

Heart Failure NYHA Class III Clinical Trial

— BESMILE-HF  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03180320
• Other study ID #: B2016-202-01
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: December 2022

Study information

• Verified date: May 2021
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Weihui Lu
• Phone: +86(020)81887233
• Email: weihui.lu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III

Intervention

Behavioral:
• BESMILE-HF program
The following activities will be conducted as part of the BESMILE-HF program: Baduanjin exercise; evaluations of exercise capacity and clinical conditions; consultations on exercise prescription and management of symptoms/signs during exercise; education covering topics related to the CHF and exercise; and a series of adherence strategies.

Drug:
• Usual medications
Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IPAQ	International Physical Activity Questionnaire	Baseline, 4 week, 8 week, 12 week
Other	Adverse events	Safety assessment	Through study completion, an average of 12 weeks
Other	MACEs	Major acute cardiac events	Through study completion, an average of 12 weeks
Other	SDANN Index	Parameters from Holter 24-hour ECG	Baseline, 12 week
Other	SDNN Index	Parameters from Holter 24-hour ECG	Baseline, 12 week
Other	All-caused mortality All-caused mortality	All-caused mortality	Through study completion, an average of 12 weeks
Other	All-caused hospitalization	All-caused hospitalization	Through study completion, an average of 12 weeks
Other	Heart failure hospitalizaiton	Heart failure hospitalizaiton	Through study completion, an average of 12 weeks
Primary	Change from baseline peak VO2 (ml/kg/min) at 12 week	Peak oxygen uptake	Baseline, 12 week
Primary	Change from baseline MLHFQ at 12 week	Minnesota Living with Heart Failure Questionnaire	Baseline,12 week
Secondary	6MWT	6-minute walking test	Baseline, 4 week, 8 week, 12 week
Secondary	TGUG	Timed get-up and-go	Baseline, 4 week, 8 week, 12 week
Secondary	SEE-C	Exercise Self-efficacy	Baseline, 4 week, 8 week, 12 week
Secondary	MLHFQ	Minnesota Living with Heart Failure Questionnaire	Baseline, 4 week, 8 week, 12 week
Secondary	EQ-5D	General quality of life	Baseline, 4 week, 8 week, 12 week
Secondary	GRC	Global Rating of Change	Baseline, 4 week, 8 week, 12 week
Secondary	LVEDD (mm)	Parameters from echocardiography: Dimensions and volumes	Baseline, 12 week
Secondary	LA (mm)	Parameters from echocardiography: Dimensions and volumes	Baseline, 12 week
Secondary	LVEF (%)	Parameters from echocardiography: Left ventricular systolic function	Baseline, 12 week
Secondary	Global longitudinal strain 2D (%)	Parameters from echocardiography: Left ventricular systolic function	Baseline, 12 week
Secondary	E/A ratio	Parameters from echocardiography: Left ventricular diastolic function	Baseline, 12 week
Secondary	NT pro-BNP	Prognostic biomarker from blood sample	Baseline, 12 week
Secondary	hsCRP	Inflammatory indicator from blood sample	Baseline, 12 week
Secondary	Total score of Patient Health Questionnaire-9 (PHQ-9)	The total score ranges from 0-27, the higher scores indicates worse outcomes	Baseline, 4 week, 8 week, 12 week
Secondary	Total score of General Anxiety Disorder-7 (GAD-7)	The total score ranges from 0-21, the higher scores indicates worse outcomes	Baseline, 4 week, 8 week, 12 week
Secondary	Number of patients who has a increand 6% PeakVO2	Number of patients who has a increand 6% PeakVO2	Baseline, 12 week