Aerobic exercise to improve cognitive and mental health in TBI patients
Develop and Rehabilitation Effects of the Safety Aerobic Exercise Prescription on Cognition, Depression and Quality of Life in Traumatic Brain Injury Patients- Taking the Cerebral Blood Circulation As a Mediator
NA · National Defense Medical Center, Taiwan · NCT04243226
This study is testing if a specific walking exercise program can help improve thinking skills and mental health for people recovering from a traumatic brain injury.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Defense Medical Center, Taiwan (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT04243226 on ClinicalTrials.gov |
What this trial studies
This study aims to create an exercise prescription for patients with traumatic brain injury (TBI) and evaluate the effectiveness of a programmed aerobic walking exercise. It will be a randomized controlled trial that assesses improvements in cognitive performance, mental health, and quality of life through increased cerebral blood flow. The study will utilize a mixed-method approach to ensure the feasibility and validity of the exercise prescription. Participants will engage in telehealth-based aerobic exercises to promote their physical and psycho-social health.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with mild to moderate traumatic brain injury who can communicate in Chinese or Taiwanese and live in Taipei or Greater Taipei.
Not a fit: Patients with severe cognitive impairments or those who regularly perform moderate-intensity aerobic exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance cognitive function and mental health in TBI patients, leading to improved quality of life.
How similar studies have performed: Previous studies have indicated positive effects of aerobic exercise on cognitive and mental health, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have been diagnosed with mild traumatic brain injury at the emergency department 2. GCS score of 14-15 at the emergency department or patients with moderate brain injury (GCS score of 8-13 3. Brain injury Patients more than three months after discharge 4. Can communicate in Chinese and Taiwanese 5. Patients who have good audio-visual ability to complete tests and data filling 6. Patients are willing to sign a consent form to participate in the research. 7. Each subject was able to walk on their own, communicate freely and live in Taipei or Greater Taipei. Exclusion Criteria: 1. Exclude those with severe impairment of cognition, emotions and executive function caused by prefrontal lobe injury 2. Exclude patients with brain injury due to head puncture. 3. Regularly perform moderate-intensity aerobic exercise.
Where this trial is running
Taipei
- TSGH — Taipei, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Hui-Hsun Chiang, PhD — National Defense Medical Center
- Study coordinator: Hui-Hsun Chiang, PhD
- Email: sheisvivian@gmail.com
- Phone: 02-8792-6692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiology, Psychiatry, physical health care, Activity of Daily Living,ADL