Clinical trial NCT04243226: Effects of Aerobic Exercise on Cognition,cerebral Brain Flow and Mental Health Among Traumatic Brain Injury Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiology
Psychiatry
Keywords: physical health care
Activity of Daily Living,ADL
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2020-01-28
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: cerebral blood flow (CBF)-(T1)
timeFrame: T1_Baseline
measure: cerebral blood flow (CBF)-(T2)
timeFrame: T2_1 month later
measure: cerebral blood flow (CBF)-(T3)
timeFrame: T3_2 months later
measure: cerebral blood flow (CBF)-(T4)
timeFrame: T4_3 months later
measure: cerebral blood flow (CBF)-(T5)
timeFrame: T5_6 months later
measure: cerebral blood flow (CBF)-(T6)
timeFrame: T6_12 months later
measure: 6 minutes walk test-(T1)
timeFrame: T1-Baseline
measure: 6 minutes walk test-(T2)
timeFrame: T2-1 month later
measure: 6 minutes walk test-(T3)
timeFrame: T3-2 months later
measure: 6 minutes walk test-(T4)
timeFrame: T4-3 months later
measure: 6 minutes walk test-(T5)
timeFrame: T5-6 months later
measure: 6 minutes walk test-(T6)
timeFrame: T6-12 months later
measure: Cardio force index (CFI)-(T1)
timeFrame: T1-Baseline
measure: Cardio force index (CFI)-(T2)
timeFrame: T2-1 month later
measure: Cardio force index (CFI)-(T3)
timeFrame: T3-2 month later
measure: Cardio force index (CFI)-(T4)
timeFrame: T4-3 months later
measure: Cardio force index (CFI)-(T5)
timeFrame: T5-6 months later
measure: Cardio force index (CFI)-(T6)
timeFrame: T6-12 months later
Secondary outcomes:
measure: Cognitive function-(T1)
timeFrame: T1-Baseline
measure: Cognitive function-(T2)
timeFrame: T2-1month later
measure: Cognitive function-(T3)
timeFrame: T3-2month later
measure: Cognitive function-(T4)
timeFrame: T4-3month later
measure: Cognitive function-(T5)
timeFrame: T5-6months later
measure: Cognitive function-(T6)
timeFrame: T6-12months later
measure: Brain single photon emission computed tomography (SPECT)-(T1)
timeFrame: T1_Baseline
measure: Brain single photon emission computed tomography (SPECT)-(T4)
timeFrame: T4_6 months later
Other outcomes:
measure: depression status-(T1)
timeFrame: T1-Baseline
measure: depression status-(T2)
timeFrame: T2-1 month later
measure: depression status-(T3)
timeFrame: T3-2 months later
measure: depression status-(T4)
timeFrame: T4-3 months later
measure: depression status-(T5)
timeFrame: T5-6 months later
measure: depression status-(T6)
timeFrame: T6-12 months later
measure: Quality of life-(T1): WHOQOL-BREF
timeFrame: T1-Baseline
measure: Quality of life-(T2): WHOQOL-BREF
timeFrame: T2-1 month later
measure: Quality of life-(T3): WHOQOL-BREF
timeFrame: T3-2 month later
measure: Quality of life-(T4): WHOQOL-BREF
timeFrame: T4-3 months later
measure: Quality of life-(T5): WHOQOL-BREF
timeFrame: T5- 6 months later
measure: Quality of life-(T6): WHOQOL-BREF
timeFrame: T6- 12 months later
measure: resilience status-(T1)
timeFrame: T1-Baseline
measure: resilience status-(T2)
timeFrame: T2-1 month later
measure: resilience status-(T3)
timeFrame: T3-2 month later
measure: resilience status-(T4)
timeFrame: T4-3 months later
measure: resilience status-(T5)
timeFrame: T5-6 months later
measure: resilience status-(T6)
timeFrame: T6-12 months later
measure: Post-concussion symptom-(T1)
timeFrame: T1-Baseline
measure: Post-concussion symptom-(T2)
timeFrame: T2-1 month later
measure: Post-concussion symptom-(T3)
timeFrame: T3-2 months later
measure: Post-concussion symptom-(T4)
timeFrame: T4-3 months later
measure: Post-concussion symptom-(T5)
timeFrame: T5-6 months later
measure: Post-concussion symptom-(T6)
timeFrame: T6-12 months later
measure: Self-efficacy-(T1)
timeFrame: T1- Baseline
measure: Self-efficacy-(T2)
timeFrame: T2- 1 month later
measure: Self-efficacy-(T3)
timeFrame: T3- 2 months later
measure: Self-efficacy-(T4)
timeFrame: T4- 3 months later
measure: Self-efficacy-(T5)
timeFrame: T5- 6 months later
measure: Self-efficacy-(T6)
timeFrame: T6- 12 months later
measure: Sleep quality-(T1)
timeFrame: T1- Baseline
measure: Sleep quality-(T2)
timeFrame: T2- 1 month later
measure: Sleep quality-(T3)
timeFrame: T3- 2 months later
measure: Sleep quality-(T4)
timeFrame: T4- 3 months later
measure: Sleep quality-(T5)
timeFrame: T5- 6 months later
measure: Sleep quality-(T6)
timeFrame: T6- 12 months later
measure: Sport motivation Scale-(T1)
timeFrame: T1- baseline
measure: Sport motivation Scale-(T2)
timeFrame: T2- 1 month later
measure: Sport motivation Scale-(T3)
timeFrame: T3- 2 month later
measure: Sport motivation Scale-(T4)
timeFrame: T4- 3 month later
measure: Sport motivation Scale-(T5)
timeFrame: T5- 6 month later
measure: Sport motivation Scale-(T6)
timeFrame: T6- 12 month later
Locations:
city: Taipei city
country: Taiwan
facility: TSGH
Study officials:
affiliation: National Defense Medical Center
name: Hui-Hsun Chiang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.