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

NCT05930288 | Not Yet Recruiting

• 1 other identifier: 202305117
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Supratentorial Brain Tumor; Exercise; Cognition; Postoperative Complications

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Average length of stay

  Discharge (up to 12 weeks)

• Postoperative pain (by 0-10 Numerical Rating Scale [0 to 10 points, with higher scores generally indicating more severe pain])

  1 week post-operative/discharge (select whichever occurs first)

• Subject satisfaction (by Patient Satisfaction Questionnaire-III [50 to 250 points, with higher scores generally indicating higher satisfaction])

  1 week post-operative/discharge (select whichever occurs first)

• Cost of care

  1 week post-operative/discharge (select whichever occurs first)

• Incidence of other postoperative surgery-related complications (cerebral haemorrhage, intracranial infections, etc.)

  1 week post-operative/discharge (select whichever occurs first)

Study Arms (2)

Walking exercise

EXPERIMENTAL

Patients receive routine care and exercise as required.

Behavioral: Walking exercise

Control

NO INTERVENTION

Patients receive only routine care.

Interventions

Walking exercise BEHAVIORAL

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.

Walking exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Related Publications (1)

• Qu C, Cao Z, Zhou J, He S, Liu F, Liu Z. Preoperative walking exercise to improve prognosis in patients with supratentorial brain tumours after craniotomy: protocol for a randomised controlled trial. BMJ Open. 2024 May 15;14(5):e080787. doi: 10.1136/bmjopen-2023-080787.

  PMID: 38754891 DERIVED

MeSH Terms

Conditions

Motor Activity; Postoperative Complications

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fangkun Liu, MD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhixiong Liu, MD

CONTACT

+86-13607318785; zhixiongliu@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 5, 2023
• Study Start: March 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 30, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)