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

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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05930288
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Xiangya Hospital of Central South University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Fangkun Liu, MD
Principal Investigator Affiliation	Xiangya Hospital of Central South University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Supratentorial Brain Tumor, Exercise, Cognition, Postoperative Complications

Arms & Interventions

Arms

Experimental: Walking exercise

Patients receive routine care and exercise as required.

No Intervention: Control

Patients receive only routine care.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.