Supratentorial Brain TumorNCT05930288
The Effect of Preoperative Walking Exercises on the Prognosis of Supratentorial Brain Tumours Patients After Craniotomy
A study testing Walking exercise in people with Supratentorial Brain Tumor and Exercise, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Supratentorial Brain Tumor, Exercise, Cognition
- What is being tested?
- Walking exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Zhixiong Liu, MD, +86-13607318785, zhixiongliu@csu.edu.cn
About this study
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
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.
- Being tested
- Walking exercise
- Medical subject headings
- Motor Activity, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Walking exercise | Experimental | Patients receive routine care and exercise as required. Receives: Behavioral: Walking exercise |
| Control | No intervention | Patients receive only routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline, 14 days preoperatively, three days preoperatively, 1 week post-operative/discharge (select whichever occurs first)
Secondary outcomes (5)
Average length of stay
Average length of hospital stay for patients.
Measured: 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])
Degree of pain felt by patient in the postoperative period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week post-operative/discharge (select whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supratentorial Brain TumorStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fangkun Liu, MD, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930288
- Sponsor's protocol ID
- 202305117
- Status last verified
- Jun 2023
- First submitted
- 19 Jun 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38754891
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05930288
- Acronym / sponsor ID
- 202305117
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking exercise | Experimental | Behavioral: Walking exercisePatients receive routine care and exercise as required. |
| Control | No intervention | –Patients receive only routine care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking exerciseThe 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. | Behavioural | Walking exercise |
Primary outcome
Incidence of postoperative cardiopulmonary complications (pneumonia, thrombosis, etc. [by Japan Clinical Oncology Group postoperative complications criteria])
Time frame: 1 week post-operative/discharge (select whichever occurs first)
Type and number of surgery-related cardiopulmonary complications that occurred after the patient's surgery.
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])
Time frame: Baseline, 14 days preoperatively, three days preoperatively, 1 week post-operative/discharge (select whichever occurs first)
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).
5 secondary outcomes
Average length of stay
Time frame: 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])
Time frame: 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])
Time frame: 1 week post-operative/discharge (select whichever occurs first)
Cost of care
Time frame: 1 week post-operative/discharge (select whichever occurs first)
Incidence of other postoperative surgery-related complications (cerebral haemorrhage, intracranial infections, etc.)
Time frame: 1 week post-operative/discharge (select whichever occurs first)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Derived from this study: PubMed 38754891Qu 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fangkun Liu, MD principal investigator
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking exercise in people with Supratentorial Brain Tumor and Exercise, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhixiong Liu, MD (+86-13607318785, zhixiongliu@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative cardiopulmonary complications (pneumonia, thrombosis, etc. [by Japan Clinical Oncology Group postoperative complications criteria]) (time frame: 1 week post-operative/discharge (select whichever occurs first)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05930288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.