Heart Failure NYHA Class IIBESMILE-HFNCT03180320
Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)
A study testing BESMILE-HF program and Usual medications in people with Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure
- What is being tested?
- BESMILE-HF program and Usual medications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2018to 30 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or above
- diagnosed with chronic heart failure
- clinically stable as defined as symptoms and signs that have remained generally unchanged for at least 1 month
- NYHA functional class II or III
Who cannot join
- patients who have contraindications to cardiopulmonary test
- patients who have contraindications to exercise training
- Patients who have serious acute or chronic organic disease or mental disorders
- history of cardiac surgery, cardiac resynchronization therapy, or intracardiac defibrillation within the previous 3 months;
- history of cardiac arrest within 1 year;
- history of peripartum cardiomyopathy, hyperthyroid heart disease, primary pulmonary hypertension;
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- inability to perform a bicycle stress test;
- severe cognitive dysfunction precluding informed consent or understanding of exercise concepts;
- current regular Baduanjin or current participation in a conventional cardiac rehabilitation program
- current participation in another trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Lu Weihui
About this 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)
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.
- Being tested
- BESMILE-HF program, Usual medications
- Keywords
- chronic heart failure, exercise-based cardiac rehabilitation, Baduanjin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BESMILE-HF programBehavioural
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.
Usual medicationsDrug
Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.
| Study group | Role | What they receive |
|---|---|---|
| BESMILE-HF group | Experimental | 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. Receives: Behavioral: BESMILE-HF program; Drug: Usual medications |
| Control | Other | 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. Receives: Drug: Usual medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline peak VO2 (ml/kg/min) at 12 week
Peak oxygen uptake
Measured: Baseline, 12 week
Change from baseline MLHFQ at 12 week
Minnesota Living with Heart Failure Questionnaire
Measured: Baseline,12 week
Secondary outcomes (16)
6MWT
6-minute walking test
Measured: Baseline, 4 week, 8 week, 12 week
TGUG
Timed get-up and-go
Measured: Baseline, 4 week, 8 week, 12 week
SEE-C
Exercise Self-efficacy
Measured: Baseline, 4 week, 8 week, 12 week
MLHFQ
Minnesota Living with Heart Failure Questionnaire
Measured: Baseline, 4 week, 8 week, 12 week
EQ-5D
General quality of life
Measured: Baseline, 4 week, 8 week, 12 week
GRC
Global Rating of Change
Measured: Baseline, 4 week, 8 week, 12 week
LVEDD (mm)
Parameters from echocardiography: Dimensions and volumes
Measured: Baseline, 12 week
LA (mm)
Parameters from echocardiography: Dimensions and volumes
Measured: Baseline, 12 week
LVEF (%)
Parameters from echocardiography: Left ventricular systolic function
Measured: Baseline, 12 week
Global longitudinal strain 2D (%)
Parameters from echocardiography: Left ventricular systolic function
Measured: Baseline, 12 week
E/A ratio
Parameters from echocardiography: Left ventricular diastolic function
Measured: Baseline, 12 week
NT pro-BNP
Prognostic biomarker from blood sample
Measured: Baseline, 12 week
hsCRP
Inflammatory indicator from blood sample
Measured: Baseline, 12 week
Total score of Patient Health Questionnaire-9 (PHQ-9)
The total score ranges from 0-27, the higher scores indicates worse outcomes
Measured: Baseline, 4 week, 8 week, 12 week
Total score of General Anxiety Disorder-7 (GAD-7)
The total score ranges from 0-21, the higher scores indicates worse outcomes
Measured: Baseline, 4 week, 8 week, 12 week
Number of patients who has a increand 6% PeakVO2
Number of patients who has a increand 6% PeakVO2
Measured: Baseline, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start22 Oct 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure NYHA Class IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihui Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Weihui Lu, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese MedicineGaetano Marrone, Principal investigator, Karolinska InstitutetWei Jiang, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese MedicineZehuai Wen, Study director, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180320
- Sponsor's protocol ID
- B2016-202-01
- Acronym
- BESMILE-HF
- Status last verified
- May 2025
- First submitted
- 2 Jun 2017
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun P, Cen H, Chen S, Chen X, Jiang W, Zhu H, Liu Y, Liu H, Lu W. Left atrial dysfunction can independently predict exercise capacity in patients with chronic heart failure who use beta-blockers. BMC Cardiovasc Disord. 2023 Mar 9;23(1):128. doi: 10.1186/s12872-023-03127-9.
PubMed 36894879Chen 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.
PubMed 34386535Chen 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.
PubMed 29490680