Clinical trial NCT03180320: Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure NYHA Class II
Heart Failure NYHA Class III
Heart Failure
Keywords: chronic heart failure
exercise-based cardiac rehabilitation
Baduanjin
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Change from baseline peak VO2 (ml/kg/min) at 12 week
timeFrame: Baseline, 12 week
measure: Change from baseline MLHFQ at 12 week
timeFrame: Baseline,12 week
Secondary outcomes:
measure: 6MWT
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: TGUG
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: SEE-C
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: MLHFQ
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: EQ-5D
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: GRC
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: LVEDD (mm)
timeFrame: Baseline, 12 week
measure: LA (mm)
timeFrame: Baseline, 12 week
measure: LVEF (%)
timeFrame: Baseline, 12 week
measure: Global longitudinal strain 2D (%)
timeFrame: Baseline, 12 week
measure: E/A ratio
timeFrame: Baseline, 12 week
measure: NT pro-BNP
timeFrame: Baseline, 12 week
measure: hsCRP
timeFrame: Baseline, 12 week
measure: Total score of Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: Total score of General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: Number of patients who has a increand 6% PeakVO2
timeFrame: Baseline, 12 week
Other outcomes:
measure: IPAQ
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: Adverse events
timeFrame: Through study completion, an average of 12 weeks
measure: MACEs
timeFrame: Through study completion, an average of 12 weeks
measure: SDANN Index
timeFrame: Baseline, 12 week
measure: SDNN Index
timeFrame: Baseline, 12 week
measure: All-caused mortality All-caused mortality
timeFrame: Through study completion, an average of 12 weeks
measure: All-caused hospitalization
timeFrame: Through study completion, an average of 12 weeks
measure: Heart failure hospitalizaiton
timeFrame: Through study completion, an average of 12 weeks
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Weihui Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Gaetano Marrone
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Wei Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Zehuai Wen
role: STUDY_DIRECTOR
References:
citation: Chen X, Jiang W, Olson TP, Lundborg CS, Wen Z, Lu W, Marrone G. Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial. Front Cardiovasc Med. 2021 Jul 27;8:715207. doi: 10.3389/fcvm.2021.715207. eCollection 2021.
citation: Chen X, Jiang W, Lin X, Lundborg CS, Wen Z, Lu W, Marrone G. Effect of an exercise-based cardiac rehabilitation program "Baduanjin Eight-Silken-Movements with self-efficacy building" for heart failure (BESMILE-HF study): study protocol for a randomized controlled trial. Trials. 2018 Mar 1;19(1):150. doi: 10.1186/s13063-018-2531-9.