PMID- 30012193 OWN - NLM STAT- MEDLINE DCOM- 20190325 LR - 20191210 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 19 IP - 1 DP - 2018 Jul 16 TI - Baduanjin exercise for patients with ischemic heart failure on phase-II cardiac rehabilitation (BEAR trial): study protocol for a prospective randomized controlled trial. PG - 381 LID - 10.1186/s13063-018-2759-4 [doi] LID - 381 AB - 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 (VO(2) peak), ventilatory anerobic threshold (VAT), The minute ventilation to carbon dioxide production relationship (VE/VCO(2) 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. FAU - Yu, Meili AU - Yu M AD - Beijing First Hospital of Integrated Chinese and Western Medicine, Beijing, 100021, China. FAU - Li, Siming AU - Li S AD - Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. FAU - Li, Siwei AU - Li S AD - Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. FAU - Li, Jingen AU - Li J AD - Department of Cardiology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, 100700, China. FAU - Xu, Hao AU - Xu H AUID- ORCID: 0000-0002-9484-9819 AD - Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. xuhaotcm@hotmail.com. FAU - Chen, Keji AU - Chen K AD - Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. kjchenvip@163.com. LA - eng SI - ClinicalTrials.gov/NCT03229681 GR - No. QG2017036/General Administration of Sport of China (CN)/ PT - Clinical Trial Protocol PT - Journal Article DEP - 20180716 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Adult MH - Aged MH - *Cardiac Rehabilitation MH - Chronic Disease MH - Clinical Trials, Phase II as Topic MH - Data Interpretation, Statistical MH - Exercise Therapy MH - Heart Failure/*rehabilitation MH - Humans MH - Middle Aged MH - *Mind-Body Therapies MH - Myocardial Ischemia/*rehabilitation MH - Outcome Assessment, Health Care MH - Patient Compliance MH - Prospective Studies MH - *Randomized Controlled Trials as Topic PMC - PMC6048837 OTO - NOTNLM OT - Baduanjin exercise OT - Cardiac rehabilitation OT - Cardiopulmonary function OT - Ischemic heart failure COIS- 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. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/07/18 06:00 MHDA- 2019/03/26 06:00 PMCR- 2018/07/16 CRDT- 2018/07/18 06:00 PHST- 2017/11/22 00:00 [received] PHST- 2018/06/25 00:00 [accepted] PHST- 2018/07/18 06:00 [entrez] PHST- 2018/07/18 06:00 [pubmed] PHST- 2019/03/26 06:00 [medline] PHST- 2018/07/16 00:00 [pmc-release] AID - 10.1186/s13063-018-2759-4 [pii] AID - 2759 [pii] AID - 10.1186/s13063-018-2759-4 [doi] PST - epublish SO - Trials. 2018 Jul 16;19(1):381. doi: 10.1186/s13063-018-2759-4.