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

Sponsor
Xiangya Hospital of Central South University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05930288
Collaborator
(none)
120
1
2
35
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Walking exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Walking exercise

Patients receive routine care and exercise as required.

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.

No Intervention: Control

Patients receive only routine care.

Outcome Measures

Primary Outcome Measures

  1. Incidence of postoperative cardiopulmonary complications (ventricular arrhythmia, pneumonia, atelectasis, etc. [by Japan Clinical Oncology Group postoperative complications criteria]) [1 week post-operative/discharge]

    Type and number of surgery-related cardiopulmonary complications that occurred after the patient's surgery

  2. Cognitive function change (by Montreal Cognitive Assessment [MoCA]) [1 week post-operative/discharge]

    The gap between patients' post-operative and pre-operative cognitive function

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  • Low-risk elective surgery patients with a preoperative waiting period of more than three to four weeks, depending on the actual medical condition and patient preferences.

Exclusion Criteria:
  • Patients whose movement may lead to tumour 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 CPET.

  • Patients who are unable to cooperate during the Montreal Cognitive Assessment (MoCA) test due to impaired consciousness or mental impairment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xiangya Hospital of Central South University Changsha Hunan China 410008

Sponsors and Collaborators

  • Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Fangkun Liu, MD, Xiangya Hospital of Central South University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier:
NCT05930288
Other Study ID Numbers:
  • 202305117
First Posted:
Jul 5, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2023