PMID- 30842109 OWN - NLM STAT- MEDLINE DCOM- 20200331 LR - 20200331 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 9 IP - 3 DP - 2019 Mar 5 TI - Effects of home-based cardiac exercise rehabilitation with remote electrocardiogram monitoring in patients with chronic heart failure: a study protocol for a randomised controlled trial. PG - e023923 LID - 10.1136/bmjopen-2018-023923 [doi] LID - e023923 AB - INTRODUCTION: Patients with chronic heart failure (CHF) can benefit from exercise rehabilitation (ER) with significant improvements in exercise capacity, quality of life and reduction in hospitalisations. Despite its reported benefits, only a small number of patients with CHF attend ER due to poor adherence, and improper exercise may even lead to adverse events. Remote ECG monitoring system (REMS) has the potential to overcome these obstacles. We hypothesise that home-based cardiac ER using REMS in CHF patients is effective compared with conventional ER without monitoring. METHODS AND ANALYSIS: This study is a prospective, randomised, parallel controlled clinical trial designed to evaluate the effectiveness of home-based phase-II ER with REMS in the treatment of CHF with a target enrolment of 120 patients (left ventricular ejection fraction <50%, New York Heart Association (NYHA) classes I to III). Patients are randomised to either REMS rehabilitation group or conventional rehabilitation group in a 1:1 ratio. All patients start an exercise training in a supervised setting and then transition to a home-based regimen. The supervised training phase consists of 12 supervised training sessions, three sessions per week for 4 weeks. During the home exercise phase, patients exercise five times per week for 8 weeks. In the REMS group, patients wear monitors during exercise to ensure that exercise intensity is within the set ranges. REMS will also detect risky arrhythmia and alert the patients and their doctors on time. The training intensity is not monitored in the conventional rehabilitation group. The primary outcome is exercise capacity improvement measured by peak oxygen uptake (VO(2) peak) (baseline vs 3 m). Secondary outcomes include 6-min walk test, NYHA classes, echocardiographic parameters, cardiac biomarkers, major adverse cardiovascular events, quality of life, psychological well-being and patients' adherence to the rehabilitation programme. ETHICS AND DISSEMINATION: This study was approved by Ethics Committee of China-Japan Friendship Hospital for Clinical Research (No. 2018-55 K39). The results of this study will be disseminated via peer-reviewed publications and presentations at conferences. TRIAL REGISTRATION NUMBER: ChiCTR-RNR-17012446; Pre-results. CI - (c) Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Li, Jiahui AU - Li J AD - Department of Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Yang, Peng AU - Yang P AD - Department of Integrative Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Fu, Dongliang AU - Fu D AD - Department of Integrative Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Ye, Xiaojun AU - Ye X AD - Department of Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Zhang, Lifang AU - Zhang L AD - Department of Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Chen, Gang AU - Chen G AD - Department of Rehabilitation, China-Japan Friendship Hospital, Beijing, China. FAU - Yang, Yiyun AU - Yang Y AD - Department of Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Luo, He AU - Luo H AD - Department of Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Chen, Li AU - Chen L AD - Phase I Clinical Ward of Clinical Trial Research Center, China-Japan Friendship Hospital, Beijing, China. FAU - Shao, Mingjing AU - Shao M AD - Department of Integrative Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Li, Chunyan AU - Li C AD - Department of Integrative Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Liu, Yi AU - Liu Y AD - Department of Integrative Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Zhou, Ying AU - Zhou Y AD - Department of Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Jiang, Hong AU - Jiang H AD - Department of Integrative Cardiology, China-Japan Friendship Hospital, Beijing, China. FAU - Li, Xianlun AU - Li X AD - Department of Cardiology, China-Japan Friendship Hospital, Beijing, China. AD - Department of Integrative Cardiology, China-Japan Friendship Hospital, Beijing, China. LA - eng SI - ChiCTR/ChiCTR-RNR-17012446 PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20190305 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM EIN - BMJ Open. 2020 Jul 28;10(7):e023923corr1. PMID: 32723752 MH - *Cardiac Rehabilitation MH - China MH - Chronic Disease MH - Electrocardiography MH - Exercise Therapy/*methods MH - Heart Failure/*rehabilitation MH - Humans MH - Monitoring, Physiologic/methods MH - Patient Compliance MH - Prospective Studies MH - *Quality of Life MH - Randomized Controlled Trials as Topic MH - *Self Care MH - Stroke Volume MH - Ventricular Function, Left MH - Walk Test PMC - PMC6429917 OTO - NOTNLM OT - cardiac exercise rehabilitation OT - chronic heart failure OT - remote electrocardiogram monitoring system OT - telerehabilitation COIS- Competing interests: None declared. EDAT- 2019/03/08 06:00 MHDA- 2020/04/01 06:00 PMCR- 2019/03/05 CRDT- 2019/03/08 06:00 PHST- 2019/03/08 06:00 [entrez] PHST- 2019/03/08 06:00 [pubmed] PHST- 2020/04/01 06:00 [medline] PHST- 2019/03/05 00:00 [pmc-release] AID - bmjopen-2018-023923 [pii] AID - 10.1136/bmjopen-2018-023923 [doi] PST - epublish SO - BMJ Open. 2019 Mar 5;9(3):e023923. doi: 10.1136/bmjopen-2018-023923.