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

Официальное название

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)

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change from baseline peak VO2 (ml/kg/min) at 12 week [Срок оценки: Baseline, 12 week]
• Change from baseline MLHFQ at 12 week [Срок оценки: Baseline,12 week]

Вторичные конечные точки (12)

• 6MWT [Срок оценки: Baseline, 4 week, 8 week, 12 week]
• TGUG [Срок оценки: Baseline, 4 week, 8 week, 12 week]
• SEE-C [Срок оценки: Baseline, 4 week, 8 week, 12 week]
• MLHFQ [Срок оценки: Baseline, 4 week, 8 week, 12 week]
• EQ-5D [Срок оценки: Baseline, 4 week, 8 week, 12 week]
• GRC [Срок оценки: Baseline, 4 week, 8 week, 12 week]
• LVEDD (mm) [Срок оценки: Baseline, 12 week]
• LA (mm) [Срок оценки: Baseline, 12 week]
• LVEF (%) [Срок оценки: Baseline, 12 week]
• Global longitudinal strain 2D (%) [Срок оценки: Baseline, 12 week]
• E/A ratio [Срок оценки: Baseline, 12 week]
• NT pro-BNP [Срок оценки: Baseline, 12 week]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Provincial Hospital of Chinese Medicine — Гуанчжоу

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT03180320 · B2016-202-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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