Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03180320
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Weihui Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Heart Failure NYHA Class II Heart Failure NYHA Class III Behavioral: BESMILE-HF program Drug: Usual medications Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention 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.
Primary Purpose: Treatment
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)
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180320


Contacts
Layout table for location contacts
Contact: Weihui Lu +86(020)81887233 ext 35837 weihui.lu@163.com
Contact: Xiankun Chen +86(020)81887233 ext 35837 chenxiankun232323@126.com

Locations
Layout table for location information
China, Guangdong
Guangdong Provincial Hospital of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Lu Weihui         
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
Layout table for investigator information
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Weihui Lu, Associate professor, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03180320     History of Changes
Other Study ID Numbers: B2016-202-01
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weihui Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine:
chronic heart failure
exercise-based cardiac rehabilitation
Baduanjin
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases