Department of Neurosurgery, Xiangya Hospital, Central South University, Changsha, China.
National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China.
BMJ Open. 2024 May 15;14(5):e080787. doi: 10.1136/bmjopen-2023-080787.
Cardiopulmonary complications and cognitive impairment following craniotomy have a significantly impact on the general health of individuals with brain tumours. Observational research indicates that engaging in walking is linked to better prognosis in patient after surgery. This trial aims to explore whether walking exercise prior to craniotomy in brain tumour patients can reduce the incidence of cardiopulmonary complications and preserve patients' cognitive function.
In this randomised controlled trial, 160 participants with supratentorial brain tumours aged 18-65 years, with a preoperative waiting time of more than 3-4 weeks and without conditions that would interfere with the trial such as cognitive impairment, will be randomly assigned in a ratio of 1:1 to either receive traditional treatment or additional combined with a period of 3-4 weeks of walking exercise of 10 000-15 000 steps per day. Wearable pedometer devices will be used to record step counts. The researchers will evaluate participants at enrolment, baseline, 14 days preoperatively, 3 days prior to surgery and 1 week after surgery or discharge (select which occurs first). The primary outcomes include the incidence of postoperative cardiopulmonary complications and changes in cognitive function (gauged by the Montreal Cognitive Assessment test). Secondary outcomes include the average length of hospital stay, postoperative pain, participant contentment, healthcare-associated costs and incidence of other postoperative surgery-related complications. We anticipate that short-term preoperative walking exercises will reduce the incidence of surgery-related complications in the short term after craniotomy, protect patients' cognitive function, aid patients' postoperative recovery and reduce the financial cost of treatment.
The study protocol has been approved by Ethics Committee of Xiangya Hospital of Central South University (approval number: 202305117). The findings of the research will be shared via publications that have been reviewed by experts in the field and through presentations at conferences.
NCT05930288.
开颅术后心肺并发症和认知障碍会显著影响脑肿瘤患者的整体健康。观察性研究表明,手术后患者进行行走锻炼与更好的预后相关。本试验旨在探讨脑肿瘤患者术前进行行走锻炼是否能降低心肺并发症的发生率并保护患者的认知功能。
这是一项随机对照试验,将纳入 160 名年龄在 18-65 岁、有术前等待时间超过 3-4 周且无认知障碍等会干扰试验条件的幕上脑肿瘤患者,按 1:1 的比例随机分配至接受传统治疗或联合治疗(增加为期 3-4 周、每天行走 10000-15000 步的锻炼)。使用可穿戴计步器记录步数。研究人员将在入组时、基线时、术前 14 天、术前 3 天和术后 1 周或出院时(先发生的为准)评估参与者。主要结局包括术后心肺并发症的发生率和认知功能的变化(用蒙特利尔认知评估量表评估)。次要结局包括平均住院时间、术后疼痛、患者满意度、医疗相关费用和其他术后手术相关并发症的发生率。我们预计短期术前行走锻炼将降低开颅术后短期内手术相关并发症的发生率,保护患者的认知功能,帮助患者术后康复,并降低治疗的经济成本。
本研究方案已获得中南大学湘雅医院伦理委员会的批准(批准文号:202305117)。研究结果将通过专家评审的出版物和会议报告进行分享。
NCT05930288。