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

NCT04243226 | Recruiting

• 1 other identifier: 30988
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiology; Psychiatry

Keywords

physical health care; Activity of Daily Living,ADL

Outcome Measures

Primary Outcomes (18)

• cerebral blood flow (CBF)-(T1)

  Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B and the brain SPECT

  T1_Baseline

• cerebral blood flow (CBF)-(T2)

  Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/Band

  T2_1 month later

• cerebral blood flow (CBF)-(T3)

  Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B

  T3_2 months later

• cerebral blood flow (CBF)-(T4)

  Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B

  T4_3 months later

• cerebral blood flow (CBF)-(T5)

  Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B and the brain SPECT

  T5_6 months later

• cerebral blood flow (CBF)-(T6)

  Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B

  T6_12 months later

• 6 minutes walk test-(T1)

  The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.The 6MWT can be used in preschool children (2-5 years), children (6-12 years) adults (18-64 years), elderly adults (65+) with a wide range of diagnoses including. The test was initially designed to help in the assessment of patient with cardiopulmonary issues. Gradually, it was introduced in numerous other conditions. It evaluates the functional capacity of the individual and it provides valuable information regarding all the systems during physical activity, including pulmonary and cardiovascular systems, blood circulation, neuromuscular units, body metabolism, and peripheral circulation.

  T1-Baseline

• 6 minutes walk test-(T2)

  The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.The 6MWT can be used in preschool children (2-5 years), children (6-12 years) adults (18-64 years), elderly adults (65+) with a wide range of diagnoses including. The test was initially designed to help in the assessment of patient with cardiopulmonary issues. Gradually, it was introduced in numerous other conditions. It evaluates the functional capacity of the individual and it provides valuable information regarding all the systems during physical activity, including pulmonary and cardiovascular systems, blood circulation, neuromuscular units, body metabolism, and peripheral circulation.

  T2-1 month later

• 6 minutes walk test-(T3)

  The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.The 6MWT can be used in preschool children (2-5 years), children (6-12 years) adults (18-64 years), elderly adults (65+) with a wide range of diagnoses including. The test was initially designed to help in the assessment of patient with cardiopulmonary issues. Gradually, it was introduced in numerous other conditions. It evaluates the functional capacity of the individual and it provides valuable information regarding all the systems during physical activity, including pulmonary and cardiovascular systems, blood circulation, neuromuscular units, body metabolism, and peripheral circulation.

  T3-2 months later

• 6 minutes walk test-(T4)

  The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.The 6MWT can be used in preschool children (2-5 years), children (6-12 years) adults (18-64 years), elderly adults (65+) with a wide range of diagnoses including. The test was initially designed to help in the assessment of patient with cardiopulmonary issues. Gradually, it was introduced in numerous other conditions. It evaluates the functional capacity of the individual and it provides valuable information regarding all the systems during physical activity, including pulmonary and cardiovascular systems, blood circulation, neuromuscular units, body metabolism, and peripheral circulation.

  T4-3 months later

• 6 minutes walk test-(T5)

  The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.The 6MWT can be used in preschool children (2-5 years), children (6-12 years) adults (18-64 years), elderly adults (65+) with a wide range of diagnoses including. The test was initially designed to help in the assessment of patient with cardiopulmonary issues. Gradually, it was introduced in numerous other conditions. It evaluates the functional capacity of the individual and it provides valuable information regarding all the systems during physical activity, including pulmonary and cardiovascular systems, blood circulation, neuromuscular units, body metabolism, and peripheral circulation.

  T5-6 months later

• 6 minutes walk test-(T6)

  The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.The 6MWT can be used in preschool children (2-5 years), children (6-12 years) adults (18-64 years), elderly adults (65+) with a wide range of diagnoses including. The test was initially designed to help in the assessment of patient with cardiopulmonary issues. Gradually, it was introduced in numerous other conditions. It evaluates the functional capacity of the individual and it provides valuable information regarding all the systems during physical activity, including pulmonary and cardiovascular systems, blood circulation, neuromuscular units, body metabolism, and peripheral circulation.

  T6-12 months later

• Cardio force index (CFI)-(T1)

  CFI was measured by Bioharness device. The ratio is HR/peak activity. CFI is the index of cardiac force, correlated to VO2 max and can predict the physiological status of physical activity. The heart rate, respiratory rate, distance of walking/ exercise and angular acceleration are also be measured by Bioharness device in the same time to calculate the CFI.

  T1-Baseline

• Cardio force index (CFI)-(T2)

  CFI was measured by Bioharness device. The ratio is HR/peak activity. CFI is the index of cardiac force, correlated to VO2 max and can predict the physiological status of physical activity. The heart rate, respiratory rate, distance of walking/ exercise and angular acceleration are also be measured by Bioharness device in the same time to calculate the CFI.

  T2-1 month later

• Cardio force index (CFI)-(T3)

  CFI was measured by Bioharness device. The ratio is HR/peak activity. CFI is the index of cardiac force, correlated to VO2 max and can predict the physiological status of physical activity. The heart rate, respiratory rate, distance of walking/ exercise and angular acceleration are also be measured by Bioharness device in the same time to calculate the CFI.

  T3-2 month later

• Cardio force index (CFI)-(T4)

  CFI was measured by Bioharness device. The ratio is HR/peak activity. CFI is the index of cardiac force, correlated to VO2 max and can predict the physiological status of physical activity. The heart rate, respiratory rate, distance of walking/ exercise and angular acceleration are also be measured by Bioharness device in the same time to calculate the CFI.

  T4-3 months later

• Cardio force index (CFI)-(T5)

  CFI was measured by Bioharness device. The ratio is HR/peak activity. CFI is the index of cardiac force, correlated to VO2 max and can predict the physiological status of physical activity. The heart rate, respiratory rate, distance of walking/ exercise and angular acceleration are also be measured by Bioharness device in the same time to calculate the CFI.

  T5-6 months later

• Cardio force index (CFI)-(T6)

  CFI was measured by Bioharness device. The ratio is HR/peak activity. CFI is the index of cardiac force, correlated to VO2 max and can predict the physiological status of physical activity. The heart rate, respiratory rate, distance of walking/ exercise and angular acceleration are also be measured by Bioharness device in the same time to calculate the CFI.

  T6-12 months later

Secondary Outcomes (8)

• Cognitive function-(T1)

  T1-Baseline

• Cognitive function-(T2)

  T2-1month later

• Cognitive function-(T3)

  T3-2month later

• Cognitive function-(T4)

  T4-3month later

• Cognitive function-(T5)

  T5-6months later

Other Outcomes (42)

• depression status-(T1)

  T1-Baseline

• depression status-(T2)

  T2-1 month later

• depression status-(T3)

  T3-2 months later

Study Arms (2)

this study is to develop exercise prescription of TBI patients

EXPERIMENTAL

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.

Device: telehealth-based aerobic walking exercise

No exercise prescription in TBI patients

NO INTERVENTION

Routine Care of TBI Patients

Interventions

telehealth-based aerobic walking exercise 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.

Also known as: aerobic exercise, walking exercise, theoretical-based aerobic exercise, walking

this study is to develop exercise prescription of TBI patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Exclude those with severe impairment of cognition, emotions and executive function caused by prefrontal lobe injury
• Exclude patients with brain injury due to head puncture.
• Regularly perform moderate-intensity aerobic exercise.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

TSGH

Taipei, Taiwan

RECRUITING

Related Publications (7)

• 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.

  PMID: 27814304 BACKGROUND

• 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.

  PMID: 12392797 BACKGROUND

• 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.

  PMID: 18425937 BACKGROUND

• 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.

  PMID: 25755918 BACKGROUND

• 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.

  PMID: 26165153 BACKGROUND

• 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.

  PMID: 27216223 BACKGROUND

• Chen HJ, Ma CY, Lin LF, Chang CC, Hueng DY, Chang YC, Chiang HH. Can symptom-severity phenotypes identify depression risk after mild traumatic brain injury? A cluster-based approach. BMC Psychiatry. 2025 Nov 4;25(1):1054. doi: 10.1186/s12888-025-07512-w.

  PMID: 41188789 DERIVED

Study Officials

• Hui-Hsun Chiang, PhD

  National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Hsun Chiang, PhD

CONTACT

02-8792-6692; sheisvivian@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 1. Traumatic brain injury patients with GCS 8-13 and GCS 14-15 2. Discharged within 3 months 3. Can communicate and conversation with Mandarin Chinese or Taiwanese 4. Agree to join the research 5. Can walk and communicate individually and live in big Taipei area.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, RN, PhD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 28, 2020
• Study Start: January 1, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)