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

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: Recruiting
• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III
• Intervention / Treatment: Behavioral: BESMILE-HF program; Drug: Usual medications

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weihui Lu; Phone Number: 35837 +86(020)81887233; Email: weihui.lu@163.com
• Study Contact Backup: Name: Xiankun Chen; Phone Number: 35837 +86(020)81887233; Email: chenxiankun232323@126.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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.; 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

Outcome Measure	Measure Description	Time Frame
Change from baseline peak VO2 (ml/kg/min) at 12 week	Peak oxygen uptake	Baseline, 12 week
Change from baseline MLHFQ at 12 week	Minnesota Living with Heart Failure Questionnaire	Baseline,12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6MWT	6-minute walking test	Baseline, 4 week, 8 week, 12 week
TGUG	Timed get-up and-go	Baseline, 4 week, 8 week, 12 week
SEE-C	Exercise Self-efficacy	Baseline, 4 week, 8 week, 12 week
MLHFQ	Minnesota Living with Heart Failure Questionnaire	Baseline, 4 week, 8 week, 12 week
EQ-5D	General quality of life	Baseline, 4 week, 8 week, 12 week
GRC	Global Rating of Change	Baseline, 4 week, 8 week, 12 week
LVEDD (mm)	Parameters from echocardiography: Dimensions and volumes	Baseline, 12 week
LA (mm)	Parameters from echocardiography: Dimensions and volumes	Baseline, 12 week
LVEF (%)	Parameters from echocardiography: Left ventricular systolic function	Baseline, 12 week
Global longitudinal strain 2D (%)	Parameters from echocardiography: Left ventricular systolic function	Baseline, 12 week
E/A ratio	Parameters from echocardiography: Left ventricular diastolic function	Baseline, 12 week
NT pro-BNP	Prognostic biomarker from blood sample	Baseline, 12 week
hsCRP	Inflammatory indicator from blood sample	Baseline, 12 week
Total score of Patient Health Questionnaire-9 (PHQ-9)	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)	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	Number of patients who has a increand 6% PeakVO2	Baseline, 12 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPAQ	International Physical Activity Questionnaire	Baseline, 4 week, 8 week, 12 week
Adverse events	Safety assessment	Through study completion, an average of 12 weeks
MACEs	Major acute cardiac events	Through study completion, an average of 12 weeks
SDANN Index	Parameters from Holter 24-hour ECG	Baseline, 12 week
SDNN Index	Parameters from Holter 24-hour ECG	Baseline, 12 week
All-caused mortality All-caused mortality	All-caused mortality	Through study completion, an average of 12 weeks
All-caused hospitalization	All-caused hospitalization	Through study completion, an average of 12 weeks
Heart failure hospitalizaiton	Heart failure hospitalizaiton	Through study completion, an average of 12 weeks

Collaborators and Investigators

• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Investigators: 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

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: chronic heart failure; exercise-based cardiac rehabilitation; Baduanjin
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID 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