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

May 14, 2025 updated by: Weihui Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangdong Provincial Hospital of Chinese Medicine
        • Contact:
          • Lu Weihui

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline peak VO2 (ml/kg/min) at 12 week
Time Frame: Baseline, 12 week
Peak oxygen uptake
Baseline, 12 week
Change from baseline MLHFQ at 12 week
Time Frame: Baseline,12 week
Minnesota Living with Heart Failure Questionnaire
Baseline,12 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6MWT
Time Frame: Baseline, 4 week, 8 week, 12 week
6-minute walking test
Baseline, 4 week, 8 week, 12 week
TGUG
Time Frame: Baseline, 4 week, 8 week, 12 week
Timed get-up and-go
Baseline, 4 week, 8 week, 12 week
SEE-C
Time Frame: Baseline, 4 week, 8 week, 12 week
Exercise Self-efficacy
Baseline, 4 week, 8 week, 12 week
MLHFQ
Time Frame: Baseline, 4 week, 8 week, 12 week
Minnesota Living with Heart Failure Questionnaire
Baseline, 4 week, 8 week, 12 week
EQ-5D
Time Frame: Baseline, 4 week, 8 week, 12 week
General quality of life
Baseline, 4 week, 8 week, 12 week
GRC
Time Frame: Baseline, 4 week, 8 week, 12 week
Global Rating of Change
Baseline, 4 week, 8 week, 12 week
LVEDD (mm)
Time Frame: Baseline, 12 week
Parameters from echocardiography: Dimensions and volumes
Baseline, 12 week
LA (mm)
Time Frame: Baseline, 12 week
Parameters from echocardiography: Dimensions and volumes
Baseline, 12 week
LVEF (%)
Time Frame: Baseline, 12 week
Parameters from echocardiography: Left ventricular systolic function
Baseline, 12 week
Global longitudinal strain 2D (%)
Time Frame: Baseline, 12 week
Parameters from echocardiography: Left ventricular systolic function
Baseline, 12 week
E/A ratio
Time Frame: Baseline, 12 week
Parameters from echocardiography: Left ventricular diastolic function
Baseline, 12 week
NT pro-BNP
Time Frame: Baseline, 12 week
Prognostic biomarker from blood sample
Baseline, 12 week
hsCRP
Time Frame: Baseline, 12 week
Inflammatory indicator from blood sample
Baseline, 12 week
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
Baseline, 4 week, 8 week, 12 week
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
Baseline, 4 week, 8 week, 12 week
Number of patients who has a increand 6% PeakVO2
Time Frame: Baseline, 12 week
Number of patients who has a increand 6% PeakVO2
Baseline, 12 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
IPAQ
Time Frame: Baseline, 4 week, 8 week, 12 week
International Physical Activity Questionnaire
Baseline, 4 week, 8 week, 12 week
Adverse events
Time Frame: Through study completion, an average of 12 weeks
Safety assessment
Through study completion, an average of 12 weeks
MACEs
Time Frame: Through study completion, an average of 12 weeks
Major acute cardiac events
Through study completion, an average of 12 weeks
SDANN Index
Time Frame: Baseline, 12 week
Parameters from Holter 24-hour ECG
Baseline, 12 week
SDNN Index
Time Frame: Baseline, 12 week
Parameters from Holter 24-hour ECG
Baseline, 12 week
All-caused mortality All-caused mortality
Time Frame: Through study completion, an average of 12 weeks
All-caused mortality
Through study completion, an average of 12 weeks
All-caused hospitalization
Time Frame: Through study completion, an average of 12 weeks
All-caused hospitalization
Through study completion, an average of 12 weeks
Heart failure hospitalizaiton
Time Frame: Through study completion, an average of 12 weeks
Heart failure hospitalizaiton
Through study completion, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Weihui Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Principal Investigator: Gaetano Marrone, Karolinska Institutet
  • Principal Investigator: Wei Jiang, Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Study Director: Zehuai Wen, Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2016-202-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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