Baduanjin exercise for patients with ischemic heart failure on phase-II cardiac rehabilitation (BEAR trial): study protocol for a prospective randomized controlled trial

Abstract

Background: Preliminary evidence based on clinical observations suggests that meditative exercise may offer potential benefits for patients with chronic heart failure (CHF). Cardiac rehabilitation (CR), as a class-IA indication in clinical practice guidelines, has been established as an effective strategy to improve quality of life and prognosis of CHF patients. Baduanjin exercise is an important component of traditional Chinese Qigong exercises. However, its benefits for CHF have not been rigorously tested. We sought to investigate whether Baduanjin, as an adjunct to standard care, improves cardiopulmonary function, exercise tolerance, and quality of life in patients with CHF caused by coronary artery disease (CAD).

Methods/design: In this randomized controlled trial, 120 patients will be randomly allocated in a 1:1 ratio to Baduanjin exercise combined with conventional exercise of CR (Baduanjin exercise group) or conventional exercise of CR alone (conventional exercise group). In addition to conventional physical activity, participants in the Baduanjin exercise group will participate in a 45-min Baduanjin exercise training session twice a week, for 12 weeks. The primary outcome is walking distance in the 6-min Walk Test (6MWT), and the secondary outcomes are peak oxygen uptake (VO2 peak), ventilatory anerobic threshold (VAT), The minute ventilation to carbon dioxide production relationship (VE/VCO2 slope), left ventricular end-diastolic volume index (LVEDVi), left ventricular ejection fraction (LVEF), quality of life assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ), amino-terminal pro-brain natriuretic peptide (NT-proBNP), hs-CRP, heart rate variability (HRV), New York Heart Association (NYHA) classification, and major adverse cardiovascular events.

Discussion: This is the first trial to evaluate the effects of a Baduanjin exercise-based CR program on cardiopulmonary function and exercise tolerance in ischemic CHF patients. If successful, it will prove the value of Baduanjin exercise in improving cardiopulmonary function and exercise tolerance in patients with ischemic heart failure on phase-II CR, and may further develop a Chinese Qigong exercise-based CR framework.

Trial registration: ClinicalTrials.gov, ID: NCT03229681 . Registered retrospectively on 23 July 2017.

Keywords: Baduanjin exercise; Cardiac rehabilitation; Cardiopulmonary function; Ischemic heart failure.

Conflict of interest statement

Ethics approval and consent to participate

All procedures were approved by the Institutional Review Boards of Xiyuan Hospital of China Academy of Chinese Medical Sciences, the Human Research Ethics Committee (Medical) of Xiyuan Hospital of China Academy of Chinese Medical Sciences (reference number: 2013XL063–1). All aspects of our study will be conducted with adherence to the current version of the Declaration of Helsinki, the guidelines established by the International Conference on Harmonization of Good Clinical Practice, and the laws of China. Informed written consent will be required of all study participants, none of whom will be denied a standard, accepted therapy.

Competing interests

The authors declare that they have no competing interests. None of authors received funding from the relevant drug manufacturers in this research.

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Figures

Fig. 1

Flow diagram of study design

Fig. 2

The duration of intervention and followed-up