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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking exercise | Experimental | Patients receive routine care and exercise as required. |
|
| Control | No Intervention | Patients receive only routine care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Average length of stay | Average length of hospital stay for patients. | 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]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhixiong Liu, MD | Contact | +86-13607318785 | zhixiongliu@csu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fangkun Liu, MD | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38754891 | Derived | 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. |
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Due to protect the patients' privacy, the investigators will not make individual patient data (IPD) publicly available. Other researchers intending to obtain IPD may contact the investigators to make a request. The investigators may share IPD if the request is approved by the Ethics Committee.
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|
Degree of pain felt by patient in the postoperative period.
| 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]) | Patient satisfaction with health care provided by physicians. | 1 week post-operative/discharge (select whichever occurs first) |
| Cost of care | The researcher will estimate the costs of hospitalisation and interventions based on data from hospital records, with unit costs taken from standard estimated costs from the Office of Medical Pricing. The analysis of program implementation costs will take into account clinician salaries, overheads and equipment costs. Formal care costs will be extracted from medical records and institutional databases, considering preoperative characteristics, type of surgery and postoperative recovery, and any complications. | 1 week post-operative/discharge (select whichever occurs first) |
| Incidence of other postoperative surgery-related complications (cerebral haemorrhage, intracranial infections, etc.) | Type and number of other surgery-related complications (cerebral haemorrhage, intracranial infections, etc.) that occurred after the patient's surgery. | 1 week post-operative/discharge (select whichever occurs first) |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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