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NCT Number: NCT03180320

Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Lu Weihui

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

BESMILE-HF program

Behavioral

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 medications

Drug

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

Primary outcomes

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

    Time frame: Baseline, 12 week

    Peak oxygen uptake

  2. Change from baseline MLHFQ at 12 week

    Time frame: Baseline,12 week

    Minnesota Living with Heart Failure Questionnaire

Secondary outcomes

  1. 6MWT

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

    6-minute walking test

  2. TGUG

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

    Timed get-up and-go

  3. SEE-C

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

    Exercise Self-efficacy

  4. MLHFQ

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

    Minnesota Living with Heart Failure Questionnaire

  5. EQ-5D

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

    General quality of life

  6. GRC

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

    Global Rating of Change

  7. LVEDD (mm)

    Time frame: Baseline, 12 week

    Parameters from echocardiography: Dimensions and volumes

  8. LA (mm)

    Time frame: Baseline, 12 week

    Parameters from echocardiography: Dimensions and volumes

  9. LVEF (%)

    Time frame: Baseline, 12 week

    Parameters from echocardiography: Left ventricular systolic function

  10. Global longitudinal strain 2D (%)

    Time frame: Baseline, 12 week

    Parameters from echocardiography: Left ventricular systolic function

  11. E/A ratio

    Time frame: Baseline, 12 week

    Parameters from echocardiography: Left ventricular diastolic function

  12. NT pro-BNP

    Time frame: Baseline, 12 week

    Prognostic biomarker from blood sample

  13. hsCRP

    Time frame: Baseline, 12 week

    Inflammatory indicator from blood sample

  14. Total score of Patient Health Questionnaire-9 (PHQ-9)

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

    The total score ranges from 0-27, the higher scores indicates worse outcomes

  15. Total score of General Anxiety Disorder-7 (GAD-7)

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

    The total score ranges from 0-21, the higher scores indicates worse outcomes

  16. Number of patients who has a increand 6% PeakVO2

    Time frame: Baseline, 12 week

    Number of patients who has a increand 6% PeakVO2

Other outcomes

  1. IPAQ

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

    International Physical Activity Questionnaire

  2. Adverse events

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

    Safety assessment

  3. MACEs

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

    Major acute cardiac events

  4. SDANN Index

    Time frame: Baseline, 12 week

    Parameters from Holter 24-hour ECG

  5. SDNN Index

    Time frame: Baseline, 12 week

    Parameters from Holter 24-hour ECG

  6. All-caused mortality All-caused mortality

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

    All-caused mortality

  7. All-caused hospitalization

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

    All-caused hospitalization

  8. Heart failure hospitalizaiton

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

    Heart failure hospitalizaiton

Study contacts

Contact information is provided by the study sponsor or research team.

Weihui Lu

CONTACT

[email protected]

+86(020)81887233 ext. 35837

Xiankun Chen

CONTACT

[email protected]

+86(020)81887233 ext. 35837

Sponsors and collaborators

Lead sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Other

Registry information

Official study 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)

Acronym: BESMILE-HF

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Jun 8, 2017
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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