Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial

Abstract

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. Clinical Trial Registration:ClinicalTrials.gov: NCT03180320.

Keywords: Baduanjin exercise; chronic heart failure; exercise-based cardiac rehabilitation; pilot randomized controlled trial; self-efficacy for exercise.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Chen, Jiang, Olson, Lundborg, Wen, Lu and Marrone.

Figures

Figure 1

Graphical depiction of the BESMILE-HF program and the research schematic process for both groups, and data collection. Each component of the BESMILE-HF program is depicted separately. We regard components either as activities or materials planned to deliver to the patients. Activities are represented by circles (to reflect their flexibility) and materials by squares (to reflect their fixed nature). Different components are labeled with different letters. Below the diagram, a legend gives a brief description of each component.

Figure 2

Flowchart of the pilot study. CPX, Cardiopulmonary exercise test; MLHFQ, Minnesota Living with Heart Failure Questionnaire.

Figure 3

Participants involvement in the BESMILE-HF program (n = 8). Participants' involvement in the BESMILE-HF program regarding the self-report home exercise and attendant rates in other scheduled sessions are shown in red. The intervention group had done the required home exercises and total home-practice time was significantly related to baseline self-efficacy. SEE, Self-efficacy for exercise; MD, mean difference.