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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, Wen Z, Lu W, Marrone G
Frontiers in Cardiovascular Medicine 2021 Jul 27;8(715207):Epub
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 to 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 versus 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT03180320.

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