Zhou Juan, Zhou Yufeng, Huang Yurong, Wang Pan
Department of cardiac surgery, Southeast University Zhongda Hospital, Nanjing, Jiangsu, China.
Department of cardiac surgery, Southeast University Zhongda Hospital, Nanjing, Jiangsu, China
BMJ Open. 2025 Sep 2;15(9):e096823. doi: 10.1136/bmjopen-2024-096823.
Evidence-based early rehabilitation intervention after heart valve surgery has been proven to have many benefits, but the experience of implementing nurse-led early rehabilitation combining exercise and psychology is still lacking. It is urgent to find a more acceptable and cost-effective method to provide exercise intervention and psychological support. The aim of this study is to design a nurse-led cardiac rehabilitation programme to increase the physical capacity and mental health for heart valve patient based on broaden-and-build theory.
A non-blinded randomised controlled trial will be conducted. A total of 86 adults diagnosed with heart valve disease will be recruited and randomly assigned to the control group and intervention group. The recovery for valvular heart disease intervention, based on the broaden-and-build theory, will be guided one-on-one by a multidisciplinary team and will consist of two main components: physical intervention and psychological intervention. The baseline assessment will be conducted 1 to 2 days after admission, and sequent evaluations will be implemented at post-intervention, 3 months after intervention and 6 months after intervention. The primary outcome is the finding of six-min walk test and mental state. Other outcomes include quality of life, 36-item short-form health survey, Short Physical Performance Battery, stress, coping modes and social support.
This study was conducted following the Helsinki Declaration and was approved by the ethics committee of the Zhong Da Hospital, Southeast University (2024ZDSYLL098-P01). The results of this study are scheduled to be published in relevant peer-reviewed journals.
Registered at the Chinese Clinical Trials.gov (ChiCTR2400090853).
心脏瓣膜手术后基于证据的早期康复干预已被证明有诸多益处，但缺乏实施由护士主导的结合运动与心理的早期康复的经验。迫切需要找到一种更易接受且具成本效益的方法来提供运动干预和心理支持。本研究旨在基于拓展与建构理论设计一项由护士主导的心脏康复计划，以提高心脏瓣膜病患者的身体能力和心理健康水平。
将进行一项非盲随机对照试验。共招募86名被诊断为心脏瓣膜病的成年人，并随机分配至对照组和干预组。基于拓展与建构理论的心脏瓣膜病干预康复将由多学科团队进行一对一指导，包括两个主要部分：身体干预和心理干预。基线评估将在入院后1至2天进行，后续评估将在干预后、干预后3个月和干预后6个月实施。主要结局是6分钟步行试验结果和精神状态。其他结局包括生活质量、36项简短健康调查问卷、简短体能表现量表、压力、应对方式和社会支持。
本研究遵循《赫尔辛基宣言》进行，并获得东南大学附属中大医院伦理委员会批准（2024ZDSYLL098-P01）。本研究结果计划发表在相关同行评审期刊上。
在中国临床试验注册中心（ChiCTR2400090853）注册。
