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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
What is being tested?
BESMILE-HF program and Usual medications
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
Are there results?
Not yet: the study is under way

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.

Weihui Lu contact

+86(020)81887233 ext. 35837

weihui.lu@163.com

Xiankun Chen contact

+86(020)81887233 ext. 35837

chenxiankun232323@126.com

China1 site, 1 recruiting

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong, 510120

    Lu Weihui

    Recruiting

Other trials in China

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:

    1. Baduanjin exercise;
    2. evaluations of exercise capacity and clinical conditions;
    3. consultations on exercise prescription and management of symptoms/signs during exercise;
    4. education covering topics related to the CHF and exercise; and
    5. 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 groups in NCT03180320
Study groupRoleWhat they receive
BESMILE-HF groupExperimentalThroughout 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
ControlOtherPatients 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.

  1. Change from baseline peak VO2 (ml/kg/min) at 12 week

    Peak oxygen uptake

    Measured: Baseline, 12 week

  2. Change from baseline MLHFQ at 12 week

    Minnesota Living with Heart Failure Questionnaire

    Measured: Baseline,12 week

Secondary outcomes (16)

  1. 6MWT

    6-minute walking test

    Measured: Baseline, 4 week, 8 week, 12 week

  2. TGUG

    Timed get-up and-go

    Measured: Baseline, 4 week, 8 week, 12 week

  3. SEE-C

    Exercise Self-efficacy

    Measured: Baseline, 4 week, 8 week, 12 week

  4. MLHFQ

    Minnesota Living with Heart Failure Questionnaire

    Measured: Baseline, 4 week, 8 week, 12 week

  5. EQ-5D

    General quality of life

    Measured: Baseline, 4 week, 8 week, 12 week

  6. GRC

    Global Rating of Change

    Measured: Baseline, 4 week, 8 week, 12 week

  7. LVEDD (mm)

    Parameters from echocardiography: Dimensions and volumes

    Measured: Baseline, 12 week

  8. LA (mm)

    Parameters from echocardiography: Dimensions and volumes

    Measured: Baseline, 12 week

  9. LVEF (%)

    Parameters from echocardiography: Left ventricular systolic function

    Measured: Baseline, 12 week

  10. Global longitudinal strain 2D (%)

    Parameters from echocardiography: Left ventricular systolic function

    Measured: Baseline, 12 week

  11. E/A ratio

    Parameters from echocardiography: Left ventricular diastolic function

    Measured: Baseline, 12 week

  12. NT pro-BNP

    Prognostic biomarker from blood sample

    Measured: Baseline, 12 week

  13. hsCRP

    Inflammatory indicator from blood sample

    Measured: Baseline, 12 week

  14. 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

  15. 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

  16. 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.

  1. First posted8 Jun 2017
  2. Study start22 Oct 2018
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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)
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 36894879

  • 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.

    PubMed 34386535

  • 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.

    PubMed 29490680

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weihui Lu (+86(020)81887233 ext. 35837, weihui.lu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline peak VO2 (ml/kg/min) at 12 week (time frame: Baseline, 12 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03180320, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.

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