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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Provincial Hospital of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Usual medications

    Drug

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: BESMILE-HF groupExperimental treatment 2 interventions
Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline peak VO2 (ml/kg/min) at 12 week

Peak oxygen uptake

Time frame
Baseline, 12 week
2

Change from baseline MLHFQ at 12 week

Minnesota Living with Heart Failure Questionnaire

Time frame
Baseline,12 week

Secondary outcomes

1

6MWT

6-minute walking test

Time frame
Baseline, 4 week, 8 week, 12 week
2

TGUG

Timed get-up and-go

Time frame
Baseline, 4 week, 8 week, 12 week
3

SEE-C

Exercise Self-efficacy

Time frame
Baseline, 4 week, 8 week, 12 week
4

MLHFQ

Minnesota Living with Heart Failure Questionnaire

Time frame
Baseline, 4 week, 8 week, 12 week

Other outcomes

1

IPAQ

International Physical Activity Questionnaire

Time frame
Baseline, 4 week, 8 week, 12 week
2

Adverse events

Safety assessment

Time frame
Through study completion, an average of 12 weeks
3

MACEs

Major acute cardiac events

Time frame
Through study completion, an average of 12 weeks
4

SDANN Index

Parameters from Holter 24-hour ECG

Time frame
Baseline, 12 week

Sponsors and contacts

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