CompletedNot Applicable

Effects of Aerobic Exercise on Cognition,Cerebral Brain Flow and Mental Health Among Traumatic Brain Injury Patients

Taiwan112 participantsStarted 2020-01-01

Plain-language summary

The aim of this study is to develop exercise prescription of TBI patients and then to evaluate the effectiveness of programmed aerobic walking exercise to improve cognitive performance, depression relief, motivation, symptom, resilience and quality of life with improvement of CBF. This will be a randomized controlled clinical trial, using a mixed method to explore the feasibility and validity of such a safety exercise prescription. Then, a randomized clinical control trial will be applied in TBI patients to evaluate the effectiveness of programmed aerobic exercise to promote psysical-psycho-social health such as cognitive status, 6 minutes walk test, depression relief, motivation, symptom, resilience and quality of life.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients who have been diagnosed with mild traumatic brain injury at the emergency department
. GCS score of 14-15 at the emergency department or patients with moderate brain injury (GCS score of 8-13
. Brain injury Patients more than three months after discharge
. Can communicate in Chinese and Taiwanese
. Patients who have good audio-visual ability to complete tests and data filling
. Patients are willing to sign a consent form to participate in the research.
. Each subject was able to walk on their own, communicate freely and live in Taipei or Greater Taipei.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

cerebral blood flow (CBF)-(T1)

Timeframe: T1_Baseline

cerebral blood flow (CBF)-(T2)

Timeframe: T2_1 month later

cerebral blood flow (CBF)-(T3)

Timeframe: T3_2 months later

cerebral blood flow (CBF)-(T4)

Timeframe: T4_3 months later

cerebral blood flow (CBF)-(T5)

Timeframe: T5_6 months later

cerebral blood flow (CBF)-(T6)

Timeframe: T6_12 months later

6 minutes walk test-(T1)

Timeframe: T1-Baseline

6 minutes walk test-(T2)

Timeframe: T2-1 month later

Trial details

NCT IDNCT04243226

SponsorNational Defense Medical Center, Taiwan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-18

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