Back to resultsBaduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study) (BESMILE-HF)
Primary Purpose
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BESMILE-HF program
Usual medications
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure NYHA Class II focused on measuring chronic heart failure, exercise-based cardiac rehabilitation, Baduanjin
Eligibility Criteria
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.
Sites / Locations
- Guangdong Provincial Hospital of Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
BESMILE-HF group
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline peak VO2 (ml/kg/min) at 12 week
Peak oxygen uptake
Change from baseline MLHFQ at 12 week
Minnesota Living with Heart Failure Questionnaire
Secondary Outcome Measures
6MWT
6-minute walking test
TGUG
Timed get-up and-go
SEE-C
Exercise Self-efficacy
MLHFQ
Minnesota Living with Heart Failure Questionnaire
EQ-5D
General quality of life
GRC
Global Rating of Change
LVEDD (mm)
Parameters from echocardiography: Dimensions and volumes
LA (mm)
Parameters from echocardiography: Dimensions and volumes
LVEF (%)
Parameters from echocardiography: Left ventricular systolic function
Global longitudinal strain 2D (%)
Parameters from echocardiography: Left ventricular systolic function
E/A ratio
Parameters from echocardiography: Left ventricular diastolic function
NT pro-BNP
Prognostic biomarker from blood sample
hsCRP
Inflammatory indicator from blood sample
Total score of Patient Health Questionnaire-9 (PHQ-9)
The total score ranges from 0-27, the higher scores indicates worse outcomes
Total score of General Anxiety Disorder-7 (GAD-7)
The total score ranges from 0-21, the higher scores indicates worse outcomes
Number of patients who has a increand 6% PeakVO2
Number of patients who has a increand 6% PeakVO2
Full Information
NCT ID
NCT03180320
First Posted
June 2, 2017
Last Updated
May 27, 2021
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03180320
Brief Title
Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)
Acronym
BESMILE-HF
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Keywords
chronic heart failure, exercise-based cardiac rehabilitation, Baduanjin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Given the nature of the intervention, it is not possible to blind the patients and personnel involved in conducting the programs.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BESMILE-HF group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BESMILE-HF program
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Usual medications
Intervention Description
Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.
Primary Outcome Measure Information:
Title
Change from baseline peak VO2 (ml/kg/min) at 12 week
Description
Peak oxygen uptake
Time Frame
Baseline, 12 week
Title
Change from baseline MLHFQ at 12 week
Description
Minnesota Living with Heart Failure Questionnaire
Time Frame
Baseline,12 week
Secondary Outcome Measure Information:
Title
6MWT
Description
6-minute walking test
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
TGUG
Description
Timed get-up and-go
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
SEE-C
Description
Exercise Self-efficacy
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
MLHFQ
Description
Minnesota Living with Heart Failure Questionnaire
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
EQ-5D
Description
General quality of life
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
GRC
Description
Global Rating of Change
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
LVEDD (mm)
Description
Parameters from echocardiography: Dimensions and volumes
Time Frame
Baseline, 12 week
Title
LA (mm)
Description
Parameters from echocardiography: Dimensions and volumes
Time Frame
Baseline, 12 week
Title
LVEF (%)
Description
Parameters from echocardiography: Left ventricular systolic function
Time Frame
Baseline, 12 week
Title
Global longitudinal strain 2D (%)
Description
Parameters from echocardiography: Left ventricular systolic function
Time Frame
Baseline, 12 week
Title
E/A ratio
Description
Parameters from echocardiography: Left ventricular diastolic function
Time Frame
Baseline, 12 week
Title
NT pro-BNP
Description
Prognostic biomarker from blood sample
Time Frame
Baseline, 12 week
Title
hsCRP
Description
Inflammatory indicator from blood sample
Time Frame
Baseline, 12 week
Title
Total score of Patient Health Questionnaire-9 (PHQ-9)
Description
The total score ranges from 0-27, the higher scores indicates worse outcomes
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
Total score of General Anxiety Disorder-7 (GAD-7)
Description
The total score ranges from 0-21, the higher scores indicates worse outcomes
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
Number of patients who has a increand 6% PeakVO2
Description
Number of patients who has a increand 6% PeakVO2
Time Frame
Baseline, 12 week
Other Pre-specified Outcome Measures:
Title
IPAQ
Description
International Physical Activity Questionnaire
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
Adverse events
Description
Safety assessment
Time Frame
Through study completion, an average of 12 weeks
Title
MACEs
Description
Major acute cardiac events
Time Frame
Through study completion, an average of 12 weeks
Title
SDANN Index
Description
Parameters from Holter 24-hour ECG
Time Frame
Baseline, 12 week
Title
SDNN Index
Description
Parameters from Holter 24-hour ECG
Time Frame
Baseline, 12 week
Title
All-caused mortality All-caused mortality
Description
All-caused mortality
Time Frame
Through study completion, an average of 12 weeks
Title
All-caused hospitalization
Description
All-caused hospitalization
Time Frame
Through study completion, an average of 12 weeks
Title
Heart failure hospitalizaiton
Description
Heart failure hospitalizaiton
Time Frame
Through study completion, an average of 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weihui Lu
Phone
+86(020)81887233
Ext
35837
Email
weihui.lu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiankun Chen
Phone
+86(020)81887233
Ext
35837
Email
chenxiankun232323@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weihui Lu
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gaetano Marrone
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Jiang
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zehuai Wen
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Weihui
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34386535
Citation
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.
Results Reference
derived
PubMed Identifier
29490680
Citation
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.
Results Reference
derived
Learn more about this trial
Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)
We'll reach out to this number within 24 hrs