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

NCT03180320 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-05-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Weihui Lu · Guangdong Provincial Hospital of Traditional Chinese Medicine

  • Gaetano Marrone · Karolinska Institutet

  • Wei Jiang · Guangdong Provincial Hospital of Traditional Chinese Medicine

  • Zehuai Wen · Guangdong Provincial Hospital of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03180320 on ClinicalTrials.gov