The Effect of Preoperative Walking Exercises on the Prognosis of Supratentorial Brain Tumours Patients After Craniotomy

Exercise Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05930288
• Other study ID #: 202305117
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: June 2023
• Source: Xiangya Hospital of Central South University
• Contact: Zhixiong Liu, MD
• Phone: +86-13607318785
• Email: zhixiongliu[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Cognition
• Exercise
• Postoperative Complications
• Supratentorial Brain Tumor

Intervention

Behavioral:
• Walking exercise
The target physical activity level for participants is to walk 10,000 steps per day and to meet or exceed that level (but not exceed 15,000 steps) seven days a week for three to four weeks. Participants will be advised to gradually increase their daily step count in proportion to their physical condition. Exercise will be performed by brisk walking or jogging using the indoor treadmill equipped by the Neurosurgery Department of Xiangya Hospital or outdoors. Each workout will begin with a 5-minute warm-up and end with a 5-minute cool-down.

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative cardiopulmonary complications (pneumonia, thrombosis, etc. [by Japan Clinical Oncology Group postoperative complications criteria])	Type and number of surgery-related cardiopulmonary complications that occurred after the patient's surgery.	1 week post-operative/discharge (select whichever occurs first)
Primary	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])	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).	Baseline, 14 days preoperatively, three days preoperatively, 1 week post-operative/discharge (select whichever occurs first)
Secondary	Average length of stay	Average length of hospital stay for patients.	Discharge (up to 12 weeks)
Secondary	Postoperative pain (by 0-10 Numerical Rating Scale [0 to 10 points, with higher scores generally indicating more severe pain])	Degree of pain felt by patient in the postoperative period.	1 week post-operative/discharge (select whichever occurs first)
Secondary	Subject satisfaction (by Patient Satisfaction Questionnaire-III [50 to 250 points, with higher scores generally indicating higher satisfaction])	Patient satisfaction with health care provided by physicians.	1 week post-operative/discharge (select whichever occurs first)
Secondary	Cost of care	The researcher will estimate the costs of hospitalisation and interventions based on data from hospital records, with unit costs taken from standard estimated costs from the Office of Medical Pricing. The analysis of program implementation costs will take into account clinician salaries, overheads and equipment costs. Formal care costs will be extracted from medical records and institutional databases, considering preoperative characteristics, type of surgery and postoperative recovery, and any complications.	1 week post-operative/discharge (select whichever occurs first)
Secondary	Incidence of other postoperative surgery-related complications (cerebral haemorrhage, intracranial infections, etc.)	Type and number of other surgery-related complications (cerebral haemorrhage, intracranial infections, etc.) that occurred after the patient's surgery.	1 week post-operative/discharge (select whichever occurs first)