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

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

NCT ID: NCT05930288

Condition: Supratentorial Brain Tumor
Exercise
Cognition
Postoperative Complications

Conditions: Official terms:
Brain Neoplasms
Postoperative Complications

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Walking exercise
Description: 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.
Arm group label: Walking exercise

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Xiangya Hospital of Central South University

Address:
City: Changsha
Zip: 410008
Country: China

Contact:
Last name: Zhixiong Liu, MD

Phone: +86-13607318785
Email: zhixiongliu@csu.edu.cn

Start date: March 1, 2024

Completion date: April 1, 2026

Lead sponsor:
Agency: Xiangya Hospital of Central South University
Agency class: Other

Source: Xiangya Hospital of Central South University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05930288