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

C

Central South University

Status

Not yet enrolling

Conditions

Postoperative Complications
Cognition
Supratentorial Brain Tumor
Exercise

Treatments

Behavioral: Walking exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05930288
202305117

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Walking exercise
Experimental group
Description:
Patients receive routine care and exercise as required.
Treatment:
Behavioral: Walking exercise
Control
No Intervention group
Description:
Patients receive only routine care.

Trial contacts and locations

1

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Central trial contact

Zhixiong Liu, MD

Data sourced from clinicaltrials.gov

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