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

NCT03180320 | Recruiting DMC

• 1 other identifier: B2016-202-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure

Keywords

chronic heart failure; exercise-based cardiac rehabilitation; Baduanjin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• 6MWT

  Baseline, 4 week, 8 week, 12 week

• TGUG

  Baseline, 4 week, 8 week, 12 week

• SEE-C

  Baseline, 4 week, 8 week, 12 week

• MLHFQ

  Baseline, 4 week, 8 week, 12 week

• EQ-5D

  Baseline, 4 week, 8 week, 12 week

Other Outcomes (8)

• IPAQ

  Baseline, 4 week, 8 week, 12 week

• Adverse events

  Through study completion, an average of 12 weeks

• MACEs

  Through study completion, an average of 12 weeks

Study Arms (2)

BESMILE-HF group

EXPERIMENTAL

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; Drug: Usual medications

Control

OTHER

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

Interventions

BESMILE-HF program BEHAVIORAL

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.

BESMILE-HF group

Usual medications DRUG

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

BESMILE-HF group; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (3)

• Sun P, Cen H, Chen S, Chen X, Jiang W, Zhu H, Liu Y, Liu H, Lu W. Left atrial dysfunction can independently predict exercise capacity in patients with chronic heart failure who use beta-blockers. BMC Cardiovasc Disord. 2023 Mar 9;23(1):128. doi: 10.1186/s12872-023-03127-9.

  PMID: 36894879 DERIVED

• 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.

  PMID: 34386535 DERIVED

• 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.

  PMID: 29490680 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Zehuai Wen

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Weihui Lu

CONTACT

+86(020)81887233; weihui.lu@163.com

Xiankun Chen

CONTACT

+86(020)81887233; chenxiankun232323@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the nature of the intervention, it is not possible to blind the patients and personnel involved in conducting the programs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 8, 2017
• Study Start: October 22, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)