机构:[1]Health Systems and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden,[2]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China,广东省中医院[3]The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China,广东省中医院[4]Department of Cardiology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China,广东省中医院[5]Division of Cardiovascular Diseases, Department of Internal Medicine, Mayo Clinic and Foundation, Rochester, MN, United States,[6]National Centre for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou, China,[7]Heart Failure Center/Department of Cardiology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China广东省中医院
Aims: The Baduanjin Eight-Silken-Movements wIth Self-Efficacy building for Heart Failure (BESMILE-HF) program is a contextually adapted cardiac rehabilitation program. It uses a traditional Chinese exercise, Baduanjin, to solve the unmet demand of exercise-based cardiac rehabilitation programs due to their scarcity and unaffordability in China. This pilot study assesses BESMILE-HF's feasibility and preliminary effects. Methods: Eighteen patients with chronic heart failure were included: 8 in a BESMILE-HF group (age: 67 +/- 5 years, EF: 40.4 +/- 13.6%) and 10 in a control group (age: 70 +/- 13 years, EF: 42.9 +/- 12.5%). Both received the usual medications, with the intervention group receiving additionally the BESMILE-HF program for 6 weeks. Feasibility was explored by participants' involvement in the intended intervention. Clinical outcome assessments were conducted at baseline and post-intervention, while adverse events were captured throughout the study period. Results: The BESMILE-HF program was well-received by patients, and adherence to the intervention was good. The intervention group completed all required home exercises and total home-practice time was correlated with baseline self-efficacy (r = 0.831, p = 0.011). Moreover, after 6 weeks, self-efficacy increased in the BESMILE-HF group (p = 0.028) and the change was higher than in the control [mean difference (MD): 3.2; 95% confidence interval (CI) 0.6-5.9, p = 0.004]. For the exercise capacity, the control group demonstrated a significant decline in peak oxygen consumption (p =0.018) whereas, the BESMILE-HF group maintained their exercise capacity (p = 0.063). Although the between-group difference was not statistically significance, there was clear clinical improvement in the BESMILE-HF group (1.5 mL/kg/min, 95% CI, -0.3 to 3.2 vs. minimal clinically important difference of 1 mL/kg/min). Throughout the study period, no adverse events related to the intervention were captured. Conclusions: BESMILE-HF is feasible for patients with chronic heart failure in Chinese settings. A larger sample size and a longer follow-up period is needed to confirm its benefit on clinical outcomes.
基金:
General Research Fund
of Traditional Chinese Medicine Science and Technology
from Guangdong Provincial Hospital of Chinese Medicine
(YN2018ML02), the Clinical Research Funding of Traditional
Chinese Medicine Science and Technology (Project
1010) from Guangdong Provincial Hospital of Chinese
Medicine (YN10101910), and the China Scholarships
Council (201608440264).
第一作者机构:[1]Health Systems and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden,[2]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China,[3]The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China,
通讯作者:
通讯机构:[3]The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China,[4]Department of Cardiology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China,[7]Heart Failure Center/Department of Cardiology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China
推荐引用方式(GB/T 7714):
Chen Xiankun,Jiang Wei,Olson Thomas P.,et al.Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial[J].FRONTIERS IN CARDIOVASCULAR MEDICINE.2021,8:doi:10.3389/fcvm.2021.715207.
APA:
Chen, Xiankun,Jiang, Wei,Olson, Thomas P.,Lundborg, Cecilia Stalsby,Wen, Zehuai...&Marrone, Gaetano.(2021).Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial.FRONTIERS IN CARDIOVASCULAR MEDICINE,8,
MLA:
Chen, Xiankun,et al."Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial".FRONTIERS IN CARDIOVASCULAR MEDICINE 8.(2021)