NCT03180320: BESMILE-HF

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

Recruiting now NA Last updated 18 May 2025

What this trial tests

NA trial testing BESMILE-HF program in Heart Failure NYHA Class II in 150 participants. Currently enrolling.

Timeline

22 October 2018

Primary endpoint
31 December 2025

30 June 2026

Quick facts

Lead sponsor	Guangdong Provincial Hospital of Traditional Chinese Medicine
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	22 October 2018
Primary completion	31 December 2025
Estimated completion	30 June 2026
Sites	1 location across China

Drugs / interventions tested

• BESMILE-HF program
• Usual medications — full drug profile →

Conditions studied

• Heart Failure NYHA Class II — all drugs for Heart Failure NYHA Class II →
• Heart Failure NYHA Class III — all drugs for Heart Failure NYHA Class III →
• Heart Failure — all drugs for Heart Failure →

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Who can join

18 and older, any sex, with Heart Failure NYHA Class II or Heart Failure NYHA Class III. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Chen X, Jiang W, Lin X, Lundborg CS, et al · · 2018 · cited 16× · PMID 29490680 · DOI 10.1186/s13063-018-2531-9
2. Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial.
   Chen X, Jiang W, Olson TP, Lundborg CS, et al · · 2021 · cited 8× · PMID 34386535 · DOI 10.3389/fcvm.2021.715207
3. Traditional <i>Baduanjin</i> exercise through the eyes of patients with chronic heart failure: A qualitative content analysis study.
   Chen X, Jiang W, Salazar M, Zhu H, et al · · 2022 · cited 5× · PMID 36684583 · DOI 10.3389/fcvm.2022.1049036
4. Left atrial dysfunction can independently predict exercise capacity in patients with chronic heart failure who use beta-blockers.
   Sun P, Cen H, Chen S, Chen X, et al · · 2023 · cited 4× · PMID 36894879 · DOI 10.1186/s12872-023-03127-9
5. Establishing a novel model to assess exercise capacity in chronic heart failure based on stress echocardiography.
   Cen H, Chen S, Feng S, Chen X, et al · · 2024 · cited 2× · PMID 39219247 · DOI 10.1002/ehf2.15038
6. Left Atrial Reservoir Longitudinal Strain is a Resting Marker of Exercise Capacity in Chronic Heart Failure: A Cross-sectional Study
   Sun P, Cen H, Chen S, Chen X, et al · · 2021 · DOI 10.21203/rs.3.rs-991212/v1