The Role of Short-term Preoperative Walking Exercises in Protecting Cognitive Function and Reducing the Incidence of Surgery-related Complications in the Short Term After Craniotomy in Patients With Supratentorial Brain Tumours
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Incidence of postoperative cardiopulmonary complications (pneumonia, thrombosis, etc. [by Japan Clinical Oncology Group postoperative complications criteria])
研究概览
简要总结
The goal of this clinical trial is to learn about in patients with supratentorial brain tumours. The main questions it aims to answer is: Can short-term preoperative walking exercise protect cognitive function in the short term after craniotomy in patients with supratentorial brain tumor and reduce the incidence of surgery-related complications? Participants will be asked to receive general care and regular walking exercises prior to surgery. Researchers will compare patients who receive only general care before surgery to see if preoperative walking exercise has an effect on postoperative prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants voluntarily joined this trial and signed the informed consent form, and were able to comply with the research procedures.
- •Male and female outpatients or inpatients aged between 18 and 65 years.
- •Patients diagnosed with supratentorial tumors through medical history, physical examination, laboratory tests, and head imaging examinations, and without symptoms of intracranial hypertension or epilepsy.
- •Patients for elective surgery at low risk, as determined by medical experts based on the patient's actual condition and patient's wishes, who are initially expected to wait for more than three to four weeks before surgery, and for whom, it is anticipated that the condition will not progress during the waiting period.
排除标准
- •The patient with a substantial brain tumor who is significantly susceptible to tumor stroke or brain herniation.
- •Patients with a clinical diagnosis of cerebral haemorrhage or intracranial infection or epilepsy.
- •Patients with acute or unstable heart disease (e.g. unstable angina or severe aortic stenosis).
- •Patients with a physical status of Grade 3, 4 or 5 according to the American Society of Anesthesiologists classification.
- •Patients with disabling orthopaedic or neuromuscular conditions.
- •Patients with a history of clinically diagnosed cognitive impairment, such as dementia and mental retardation.
- •Patients with a current or previous diagnosis of significant mental illness, chronic neurological disease or active substance abuse (as per the Diagnostic and Statistical Manual of Mental Disorders 5th edition).
- •Patients with heart failure (New York Heart Association Class 3 or Class 4 functional class).
- •Patients with severe chronic obstructive pulmonary disease (exertional expiratory volume in the first second of exhalation < 50% of predicted value).
- •Patients with anaemia (symptomatic or haematocrit < 30%).
- •Patients who have participated in other trials 1 month before or during the trial.
- •Patients who are prohibited from exercising without face-to-face supervision as assessed by the Physical Activity Readiness Questionnaire (PAR-Q) or as judged by the exercise physician based on the cardiopulmonary exercise testing (CPET).
- •Patients who are unable to cooperate during the Montreal Cognitive Assessment (MoCA) test due to impaired consciousness or mental impairment.
- •Patients with motor dysfunctions, such as hemiplegia.
结局指标
主要结局
Incidence of postoperative cardiopulmonary complications (pneumonia, thrombosis, etc. [by Japan Clinical Oncology Group postoperative complications criteria])
时间窗: 1 week post-operative/discharge (select whichever occurs first)
Type and number of surgery-related cardiopulmonary complications that occurred after the patient's surgery.
Cognitive function change (by Montreal Cognitive Assessment [MoCA], MoCA Chinese 7.1 and MoCA Chinese 7.2 [both ranging from 0 to 30 points, with higher scores generally indicating better cognitive function])
时间窗: Baseline, 14 days preoperatively, three days preoperatively, 1 week post-operative/discharge (select whichever occurs first)
The gap between patients' post-operative and pre-operative cognitive function. MoCA Chinese 7.1 for baseline and 14 days preoperatively, MoCA Chinese 7.2 for three days preoperatively and 1 week post-operative/discharge (select whichever occurs first).
次要结局
- Postoperative pain (by 0-10 Numerical Rating Scale [0 to 10 points, with higher scores generally indicating more severe pain])(1 week post-operative/discharge (select whichever occurs first))
- Average length of stay(Discharge (up to 12 weeks))
- Subject satisfaction (by Patient Satisfaction Questionnaire-III [50 to 250 points, with higher scores generally indicating higher satisfaction])(1 week post-operative/discharge (select whichever occurs first))
- Cost of care(1 week post-operative/discharge (select whichever occurs first))
- Incidence of other postoperative surgery-related complications (cerebral haemorrhage, intracranial infections, etc.)(1 week post-operative/discharge (select whichever occurs first))