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

NCT ID: NCT04243226

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2026-08-31

Brief 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.

Detailed Description

Traumatic Brain Injury (TBI) brings out the major cause of accidental disability. Aerobic exercise can increase the influx of blood circulation improving cognitive performance, such as walking and cycling. Yet the effective exercise prescription improves cerebral blood flow (CBF) on promoting psysical-psycho-social health such as cognitive status, 6 minutes walk test, depression relief, motivation, symptom, resilience and quality of life. PI conducted a retrospective study in TBI patients and results indicated that 93% of patients discharged among 5000 TBI patients in the past decade. However, about 70% TBI outpatients have squeals left by TBI, which not only affect physical activity, cognition, but also cause mental health problems such as depression and also family care burden and huge medical burdens. The preliminary data showed the significant effects of promoting cerebral blood flow (CBF) through aerobic exercise. This study intends to explore the effectiveness of aerobic exercise prescription among patients with TBI on their physical and mental health based on PI's experiences of walking exercise intervention research and their publications.

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

First, a concurrent parallel design combining qualitative and quantitative mixed methods approach will be conducted to explore the accuracy and appropriateness of the prescription and predictability of the mental health and user's experiences. We plan to recruit 30 TBI patients who will be intervened with moderate to high intensity aerobic exercise. We will collect informations regarding CBF and cardiac force index (CFI) during the progress of aerobic exercise. Moreover, we will evaluate the psysical-psycho-social health such as cognitive status, 6 minutes walk test, depression relief, motivation, symptom, resilience and quality of life. We will examine the sensitivity, specificity and accuracy of the CFI and CBF monitor system, and to explore the experience of adopting aerobic exercise prescription among TBI patients. Depending on the results of the first two years, the safety aerobic exercise prescription with CFI and CBF monitor system will be modified and piloted in the next stage. We plan to recruit at least 120 patients and randomized them into an intervention group (N=60) that received the aerobic exercise prescription and a control group (N=60) that received usual care. Outcome variables will be followed at the pretest, the first, second, third and sixth month after the exercise prescription has been implemented. Intention-to-treat and multiple linear models will be used to analyze the results. We hope to develop the safety aerobic exercise prescription with empirical evidence of promoting mental health for patients with TBI.

Conditions

Cardiology; Psychiatry

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

this study is to develop exercise prescription of TBI patients

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

Group Type: EXPERIMENTAL

telehealth-based aerobic walking exercise

Intervention Type: DEVICE

The aim of this study is to develop exercise prescription of TBI patients and then to evaluate the effectiveness of programmed aerobic exercise to improve psysical-psycho-social health such as cognitive status, 6 minutes walk test, depression relief, motivation, symptom, resilience and quality of life.

No exercise prescription in TBI patients

Routine Care of TBI Patients

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

telehealth-based aerobic walking exercise

The aim of this study is to develop exercise prescription of TBI patients and then to evaluate the effectiveness of programmed aerobic exercise to improve psysical-psycho-social health such as cognitive status, 6 minutes walk test, depression relief, motivation, symptom, resilience and quality of life.

Intervention Type: DEVICE

Other Intervention Names

aerobic exercise; walking exercise; theoretical-based aerobic exercise; walking

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Defense Medical Center, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Hui-Hsun Chiang

Associate Professor, RN, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui-Hsun Chiang, PhD

Role: PRINCIPAL_INVESTIGATOR

National Defense Medical Center

Locations

TSGH

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hui-Hsun Chiang, PhD

Role: CONTACT

sheisvivian@gmail.com

02-8792-6692 ext. 18761

References

Vanderbeken I, Kerckhofs E. A systematic review of the effect of physical exercise on cognition in stroke and traumatic brain injury patients. NeuroRehabilitation. 2017;40(1):33-48. doi: 10.3233/NRE-161388.

Reference Type: BACKGROUND

PMID: 27814304 (View on PubMed)

Churchill JD, Galvez R, Colcombe S, Swain RA, Kramer AF, Greenough WT. Exercise, experience and the aging brain. Neurobiol Aging. 2002 Sep-Oct;23(5):941-55. doi: 10.1016/s0197-4580(02)00028-3.

Reference Type: BACKGROUND

PMID: 12392797 (View on PubMed)

Hassett LM, Moseley AM, Tate R, Harmer AR. Fitness training for cardiorespiratory conditioning after traumatic brain injury. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD006123. doi: 10.1002/14651858.CD006123.pub2.

Reference Type: BACKGROUND

PMID: 18425937 (View on PubMed)

Snyder HR, Kaiser RH, Warren SL, Heller W. Obsessive-compulsive disorder is associated with broad impairments in executive function: A meta-analysis. Clin Psychol Sci. 2015 Mar;3(2):301-330. doi: 10.1177/2167702614534210.

Reference Type: BACKGROUND

PMID: 25755918 (View on PubMed)

Taylor JM, Montgomery MH, Gregory EJ, Berman NE. Exercise preconditioning improves traumatic brain injury outcomes. Brain Res. 2015 Oct 5;1622:414-29. doi: 10.1016/j.brainres.2015.07.009. Epub 2015 Jul 9.

Reference Type: BACKGROUND

PMID: 26165153 (View on PubMed)

Devine JM, Wong B, Gervino E, Pascual-Leone A, Alexander MP. Independent, Community-Based Aerobic Exercise Training for People With Moderate-to-Severe Traumatic Brain Injury. Arch Phys Med Rehabil. 2016 Aug;97(8):1392-7. doi: 10.1016/j.apmr.2016.04.015. Epub 2016 May 20.

Reference Type: BACKGROUND

PMID: 27216223 (View on PubMed)

Other Identifiers

30988

Identifier Type: -

Identifier Source: org_study_id