Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
Healthy Volunteers
ID04243226

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

Led by National Defense Medical Center, Taiwan · Updated on 2025-02-14

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Defense Medical Center, Taiwan

Lead Sponsor

M

Ministry of Science and Technology, Taiwan

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a programmed aerobic walking exercise on patients who have experienced traumatic brain injury (TBI). The study aims to improve various aspects of physical and mental health including cognitive performance, depression relief, motivation, symptoms, resilience, and quality of life. It focuses on how aerobic exercise may enhance cerebral blood flow (CBF) and overall psycho-social health in TBI patients. This is a randomized controlled clinical trial using a mixed method approach to assess the safety and effectiveness of this exercise prescription. The study includes an initial phase where 30 patients will undergo moderate to high intensity aerobic exercise, monitoring cerebral blood flow and cardiac force index during exercise. Following this, at least 120 patients will be randomly assigned to either an intervention group receiving the aerobic exercise prescription or a control group receiving routine care. Outcomes will be evaluated at baseline and at 1, 2, 3, 6, and 12 months after starting the exercise program to assess changes in cognitive status, physical endurance (6-minute walk test), depression, motivation, symptoms, resilience, and quality of life. Participants will be closely monitored with repeated assessments including cerebral blood flow, cardiac force index, cognitive function tests, and brain imaging scans. Data will be collected at multiple time points over a year to evaluate the intervention's impact on physical, psychological, and social health. The study also explores the feasibility and user experience of the aerobic exercise prescription to ensure safety and applicability for TBI patients. Total participation may last up to 12 months with ongoing follow-up and evaluation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with mild traumatic brain injury at the emergency department
  • Glasgow Coma Scale (GCS) score of 14-15 for mild or 8-13 for moderate brain injury
  • More than three months since discharge after brain injury
  • Able to communicate in Chinese and Taiwanese
  • Good hearing and vision to complete tests and data collection
  • Willing to sign consent to participate
  • Able to walk independently, communicate freely, and live in Taipei or Greater Taipei area
Not Eligible

You will not qualify if you...

  • Severe cognitive, emotional, or executive function impairment due to prefrontal lobe injury
  • Brain injury caused by head puncture
  • Regularly performing moderate-intensity aerobic exercise

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 6 months

Participants in the intervention group follow a telehealth-based aerobic walking exercise program designed to improve physical, cognitive, and mental health after traumatic brain injury. Participants in the control group receive routine care without exercise prescription.

Visits at baseline, 1 month, 2 months, 3 months, and 6 months after starting the exercise prescription

Follow-up

Duration - Up to 6 additional months after intervention

Participants are monitored for continued effects on cerebral blood flow, cognition, physical function, and mental health up to 12 months after starting the intervention.

Visit at 12 months after starting the exercise prescription

Trial Site Locations

Total: 1 location

1

TSGH

Taipei, Taiwan

Actively Recruiting

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Research Team

H

Hui-Hsun Chiang, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Obsessive-compulsive disorder is associated with broad impairments in executive function: A meta-analysis.

Hannah R Snyder, Roselinde H Kaiser, Stacie L Warren...

https://pubmed.ncbi.nlm.nih.gov/25755918

Independent, Community-Based Aerobic Exercise Training for People With Moderate-to-Severe Traumatic Brain Injury.

Jennifer M Devine, Bonnie Wong, Ernest Gervino...

https://pubmed.ncbi.nlm.nih.gov/27216223