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RecruitingNCT03180320BESMILE-HFUpdated May 18, 2025

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

An interventional study of BESMILE-HF program and Usual medications in Heart Failure NYHA Class II, Heart Failure NYHA Class III and Heart Failure, sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Oct 2018; still recruiting 7 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • chronic heart failure
  • exercise-based cardiac rehabilitation
  • Baduanjin
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 150 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    BESMILE-HF group

    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.

    Behavioral: BESMILE-HF program · Drug: Usual medications

  • Other
    Control

    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.

    Drug: Usual medications

Interventions

  • BehavioralBESMILE-HF program

    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.

  • DrugUsual medications

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

06

What researchers measure

Primary outcomes

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

    Peak oxygen uptake

    Time frame: Baseline, 12 week

  2. Change from baseline MLHFQ at 12 week

    Minnesota Living with Heart Failure Questionnaire

    Time frame: Baseline,12 week

Secondary outcomes

  1. 6MWT

    6-minute walking test

    Time frame: Baseline, 4 week, 8 week, 12 week

  2. TGUG

    Timed get-up and-go

    Time frame: Baseline, 4 week, 8 week, 12 week

  3. SEE-C

    Exercise Self-efficacy

    Time frame: Baseline, 4 week, 8 week, 12 week

  4. MLHFQ

    Minnesota Living with Heart Failure Questionnaire

    Time frame: Baseline, 4 week, 8 week, 12 week

  5. EQ-5D

    General quality of life

    Time frame: Baseline, 4 week, 8 week, 12 week

  6. GRC

    Global Rating of Change

    Time frame: Baseline, 4 week, 8 week, 12 week

  7. LVEDD (mm)

    Parameters from echocardiography: Dimensions and volumes

    Time frame: Baseline, 12 week

  8. LA (mm)

    Parameters from echocardiography: Dimensions and volumes

    Time frame: Baseline, 12 week

  9. LVEF (%)

    Parameters from echocardiography: Left ventricular systolic function

    Time frame: Baseline, 12 week

  10. Global longitudinal strain 2D (%)

    Parameters from echocardiography: Left ventricular systolic function

    Time frame: Baseline, 12 week

  11. E/A ratio

    Parameters from echocardiography: Left ventricular diastolic function

    Time frame: Baseline, 12 week

  12. NT pro-BNP

    Prognostic biomarker from blood sample

    Time frame: Baseline, 12 week

  13. hsCRP

    Inflammatory indicator from blood sample

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, 12 week

Other outcomes

  1. IPAQ

    International Physical Activity Questionnaire

    Time frame: Baseline, 4 week, 8 week, 12 week

  2. Adverse events

    Safety assessment

    Time frame: Through study completion, an average of 12 weeks

  3. MACEs

    Major acute cardiac events

    Time frame: Through study completion, an average of 12 weeks

  4. SDANN Index

    Parameters from Holter 24-hour ECG

    Time frame: Baseline, 12 week

  5. SDNN Index

    Parameters from Holter 24-hour ECG

    Time frame: Baseline, 12 week

  6. All-caused mortality All-caused mortality

    All-caused mortality

    Time frame: Through study completion, an average of 12 weeks

  7. All-caused hospitalization

    All-caused hospitalization

    Time frame: Through study completion, an average of 12 weeks

  8. Heart failure hospitalizaiton

    Heart failure hospitalizaiton

    Time frame: Through study completion, an average of 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Guangdong Provincial Hospital of Chinese Medicine
    Guangzhou, Guangdong 510120, China
    • Lu Weihui · Contact
    Recruiting
08

References and documents

Publications

  • 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03180320
Lead sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Responsible party
Weihui Lu (Professor, Guangdong Provincial Hospital of Traditional Chinese Medicine) — Principal investigator
First posted
Jun 8, 2017
Start date
Oct 22, 2018
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
May 18, 2025

Study contacts

Weihui Lu
Contact
weihui.lu@163.com
+86(020)81887233 ext. 35837
Xiankun Chen
Contact
chenxiankun232323@126.com
+86(020)81887233 ext. 35837
Weihui Lu
principal investigator · Guangdong Provincial Hospital of Traditional Chinese Medicine
Gaetano Marrone
principal investigator · Karolinska Institutet
Wei Jiang
principal investigator · Guangdong Provincial Hospital of Traditional Chinese Medicine
Zehuai Wen
study director · Guangdong Provincial Hospital of Traditional Chinese Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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