Clinical trial NCT05930288: The Effect of Preoperative Walking Exercises on the Prognosis of Supratentorial Brain Tumours Patients After Craniotomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Supratentorial Brain Tumor
Exercise
Cognition
Postoperative Complications
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of postoperative cardiopulmonary complications (pneumonia, thrombosis, etc. [by Japan Clinical Oncology Group postoperative complications criteria])
timeFrame: 1 week post-operative/discharge (select whichever occurs first)
measure: 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])
timeFrame: Baseline, 14 days preoperatively, three days preoperatively, 1 week post-operative/discharge (select whichever occurs first)
Secondary outcomes:
measure: Average length of stay
timeFrame: Discharge (up to 12 weeks)
measure: Postoperative pain (by 0-10 Numerical Rating Scale [0 to 10 points, with higher scores generally indicating more severe pain])
timeFrame: 1 week post-operative/discharge (select whichever occurs first)
measure: Subject satisfaction (by Patient Satisfaction Questionnaire-III [50 to 250 points, with higher scores generally indicating higher satisfaction])
timeFrame: 1 week post-operative/discharge (select whichever occurs first)
measure: Cost of care
timeFrame: 1 week post-operative/discharge (select whichever occurs first)
measure: Incidence of other postoperative surgery-related complications (cerebral haemorrhage, intracranial infections, etc.)
timeFrame: 1 week post-operative/discharge (select whichever occurs first)
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Fangkun Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: