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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cardiology, Psychiatry

Intervention / Treatment
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* Device: telehealth-based aerobic walking exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: this study is to develop exercise prescription of TBI patients<br>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<br>* 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.<br>* Other names: walking;|
| No Intervention: No exercise prescription in TBI patients<br>Routine Care of TBI Patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function-(T1) | Cognitive function will be measured by the Mini-Mental State Exam (MMSE )instrument. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function ... school (but not a graduate of), a score on the MMSE of 24 or below means cognitive impairment. | T1-Baseline | 
| Cognitive function-(T2) | Cognitive function will be measured by the Mini-Mental State Exam (MMSE )instrument. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function ... school (but not a graduate of), a score on the MMSE of 24 or below means cognitive impairment. | T2-1month later | 
| Cognitive function-(T3) | Cognitive function will be measured by the Mini-Mental State Exam (MMSE )instrument. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function ... school (but not a graduate of), a score on the MMSE of 24 or below means cognitive impairment. | T3-2month later | 
| Cognitive function-(T4) | Cognitive function will be measured by the Mini-Mental State Exam (MMSE )instrument. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function ... school (but not a graduate of), a score on the MMSE of 24 or below means cognitive impairment. | T4-3month later | 
| Cognitive function-(T5) | Cognitive function will be measured by the Mini-Mental State Exam (MMSE )instrument. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function ... school (but not a graduate of), a score on the MMSE of 24 or below means cognitive impairment. | T5-6months later | 
| Cognitive function-(T6) | Cognitive function will be measured by the Mini-Mental State Exam (MMSE )instrument. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function ... school (but not a graduate of), a score on the MMSE of 24 or below means cognitive impairment. | T6-12months later | 
| Brain single photon emission computed tomography (SPECT)-(T1) | brain Single Photon Emission Computed Tomography (SPECT) imaging has developed a substantial, evidence-based foundation and is now recommended by professional societies for numerous indications relevant to psychiatric practice. | T1_Baseline | 
| Brain single photon emission computed tomography (SPECT)-(T4) | brain Single Photon Emission Computed Tomography (SPECT) imaging has developed a substantial, evidence-based foundation and is now recommended by professional societies for numerous indications relevant to psychiatric practice. | T4_6 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical health care, Activity of Daily Living,ADL