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

Primary Purpose

Cardiology, Psychiatry

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
telehealth-based aerobic walking exercise
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiology focused on measuring physical health care, Activity of Daily Living,ADL

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • TSGHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

this study is to develop exercise prescription of TBI patients

No exercise prescription in TBI patients

Arm Description

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.

Routine Care of TBI Patients

Outcomes

Primary Outcome Measures

cerebral blood flow (CBF)-(T1)
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B and the brain SPECT
cerebral blood flow (CBF)-(T2)
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/Band
cerebral blood flow (CBF)-(T3)
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B
cerebral blood flow (CBF)-(T4)
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B
cerebral blood flow (CBF)-(T5)
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B and the brain SPECT
cerebral blood flow (CBF)-(T6)
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 20, 2020
Last Updated
September 26, 2022
Sponsor
National Defense Medical Center, Taiwan
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04243226
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiology, Psychiatry
Keywords
physical health care, Activity of Daily Living,ADL

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Masking Description
Traumatic brain injury patients with GCS 8-13 and GCS 14-15 Discharged within 3 months Can communicate and conversation with Mandarin Chinese or Taiwanese Agree to join the research Can walk and communicate individually and live in big Taipei area.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
this study is to develop exercise prescription of TBI patients
Arm Type
Experimental
Arm Description
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.
Arm Title
No exercise prescription in TBI patients
Arm Type
No Intervention
Arm Description
Routine Care of TBI Patients
Intervention Type
Device
Intervention Name(s)
telehealth-based aerobic walking exercise
Other Intervention Name(s)
aerobic exercise, walking exercise, theoretical-based aerobic exercise, walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
cerebral blood flow (CBF)-(T1)
Description
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B and the brain SPECT
Time Frame
T1_Baseline
Title
cerebral blood flow (CBF)-(T2)
Description
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/Band
Time Frame
T2_1 month later
Title
cerebral blood flow (CBF)-(T3)
Description
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B
Time Frame
T3_2 months later
Title
cerebral blood flow (CBF)-(T4)
Description
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B
Time Frame
T4_3 months later
Title
cerebral blood flow (CBF)-(T5)
Description
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B and the brain SPECT
Time Frame
T5_6 months later
Title
cerebral blood flow (CBF)-(T6)
Description
Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B
Time Frame
T6_12 months later
Title
6 minutes walk test-(T1)
Description
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.
Time Frame
T1-Baseline
Title
6 minutes walk test-(T2)
Description
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.
Time Frame
T2-1 month later
Title
6 minutes walk test-(T3)
Description
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.
Time Frame
T3-2 months later
Title
6 minutes walk test-(T4)
Description
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.
Time Frame
T4-3 months later
Title
6 minutes walk test-(T5)
Description
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.
Time Frame
T5-6 months later
Title
6 minutes walk test-(T6)
Description
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.
Time Frame
T6-12 months later
Title
Cardio force index (CFI)-(T1)
Description
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.
Time Frame
T1-Baseline
Title
Cardio force index (CFI)-(T2)
Description
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.
Time Frame
T2-1 month later
Title
Cardio force index (CFI)-(T3)
Description
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.
Time Frame
T3-2 month later
Title
Cardio force index (CFI)-(T4)
Description
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.
Time Frame
T4-3 months later
Title
Cardio force index (CFI)-(T5)
Description
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.
Time Frame
T5-6 months later
Title
Cardio force index (CFI)-(T6)
Description
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.
Time Frame
T6-12 months later
Secondary Outcome Measure Information:
Title
Cognitive function-(T1)
Description
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.
Time Frame
T1-Baseline
Title
Cognitive function-(T2)
Description
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.
Time Frame
T2-1month later
Title
Cognitive function-(T3)
Description
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.
Time Frame
T3-2month later
Title
Cognitive function-(T4)
Description
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.
Time Frame
T4-3month later
Title
Cognitive function-(T5)
Description
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.
Time Frame
T5-6months later
Title
Cognitive function-(T6)
Description
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.
Time Frame
T6-12months later
Title
Brain single photon emission computed tomography (SPECT)-(T1)
Description
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.
Time Frame
T1_Baseline
Title
Brain single photon emission computed tomography (SPECT)-(T4)
Description
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.
Time Frame
T4_6 months later
Other Pre-specified Outcome Measures:
Title
depression status-(T1)
Description
Depression will be measured by Beck depression index (BDI). The BDI scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past. The items of the scale are symptoms associated with depression which have been used in previously validated longer scales. A score is assigned by totaling all items (after reversing the positive mood items]. The possible range for the 21-item scale is 0 to 63, and a cut off score of 16 or higher indicates the presence of significant depressive symptoms.
Time Frame
T1-Baseline
Title
depression status-(T2)
Description
Depression will be measured by Beck depression index (BDI). The BDI scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past. The items of the scale are symptoms associated with depression which have been used in previously validated longer scales. A score is assigned by totaling all items (after reversing the positive mood items]. The possible range for the 21-item scale is 0 to 63, and a cut off score of 16 or higher indicates the presence of significant depressive symptoms.
Time Frame
T2-1 month later
Title
depression status-(T3)
Description
Depression will be measured by Beck depression index (BDI). The BDI scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past. The items of the scale are symptoms associated with depression which have been used in previously validated longer scales. A score is assigned by totaling all items (after reversing the positive mood items]. The possible range for the 21-item scale is 0 to 63, and a cut off score of 16 or higher indicates the presence of significant depressive symptoms.
Time Frame
T3-2 months later
Title
depression status-(T4)
Description
Depression will be measured by Beck depression index (BDI). The BDI scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past. The items of the scale are symptoms associated with depression which have been used in previously validated longer scales. A score is assigned by totaling all items (after reversing the positive mood items]. The possible range for the 21-item scale is 0 to 63, and a cut off score of 16 or higher indicates the presence of significant depressive symptoms.
Time Frame
T4-3 months later
Title
depression status-(T5)
Description
Depression will be measured by Beck depression index (BDI). The BDI scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past. The items of the scale are symptoms associated with depression which have been used in previously validated longer scales. A score is assigned by totaling all items (after reversing the positive mood items]. The possible range for the 21-item scale is 0 to 63, and a cut off score of 16 or higher indicates the presence of significant depressive symptoms.
Time Frame
T5-6 months later
Title
depression status-(T6)
Description
Depression will be measured by Beck depression index (BDI). The BDI scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past. The items of the scale are symptoms associated with depression which have been used in previously validated longer scales. A score is assigned by totaling all items (after reversing the positive mood items]. The possible range for the 21-item scale is 0 to 63, and a cut off score of 16 or higher indicates the presence of significant depressive symptoms.
Time Frame
T6-12 months later
Title
Quality of life-(T1): WHOQOL-BREF
Description
Quality of life will be measured by World Health organization quality of life (WHOQOL) instrument. The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items.The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
Time Frame
T1-Baseline
Title
Quality of life-(T2): WHOQOL-BREF
Description
Quality of life will be measured by World Health organization quality of life (WHOQOL) instrument. The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items.The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
Time Frame
T2-1 month later
Title
Quality of life-(T3): WHOQOL-BREF
Description
Quality of life will be measured by World Health organization quality of life (WHOQOL) instrument. The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items.The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
Time Frame
T3-2 month later
Title
Quality of life-(T4): WHOQOL-BREF
Description
Quality of life will be measured by World Health organization quality of life (WHOQOL) instrument. The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items.The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
Time Frame
T4-3 months later
Title
Quality of life-(T5): WHOQOL-BREF
Description
Quality of life will be measured by World Health organization quality of life (WHOQOL) instrument. The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items.The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
Time Frame
T5- 6 months later
Title
Quality of life-(T6): WHOQOL-BREF
Description
Quality of life will be measured by World Health organization quality of life (WHOQOL) instrument. The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items.The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
Time Frame
T6- 12 months later
Title
resilience status-(T1)
Description
Resilience will be measured by Resilience scale for adult scale. The Resilience Scale for Adults (RSA) (Friborg et al., 2003) is a 37-item scale that measures resilience as healthy adaptation and personal competence during exposure to significant adversity, trauma, or stress.
Time Frame
T1-Baseline
Title
resilience status-(T2)
Description
Resilience will be measured by Resilience scale for adult scale. The Resilience Scale for Adults (RSA) (Friborg et al., 2003) is a 37-item scale that measures resilience as healthy adaptation and personal competence during exposure to significant adversity, trauma, or stress.
Time Frame
T2-1 month later
Title
resilience status-(T3)
Description
Resilience will be measured by Resilience scale for adult scale. The Resilience Scale for Adults (RSA) (Friborg et al., 2003) is a 37-item scale that measures resilience as healthy adaptation and personal competence during exposure to significant adversity, trauma, or stress.
Time Frame
T3-2 month later
Title
resilience status-(T4)
Description
Resilience will be measured by Resilience scale for adult scale. The Resilience Scale for Adults (RSA) (Friborg et al., 2003) is a 37-item scale that measures resilience as healthy adaptation and personal competence during exposure to significant adversity, trauma, or stress.
Time Frame
T4-3 months later
Title
resilience status-(T5)
Description
Resilience will be measured by Resilience scale for adult scale. The Resilience Scale for Adults (RSA) (Friborg et al., 2003) is a 37-item scale that measures resilience as healthy adaptation and personal competence during exposure to significant adversity, trauma, or stress.
Time Frame
T5-6 months later
Title
resilience status-(T6)
Description
Resilience will be measured by Resilience scale for adult scale. The Resilience Scale for Adults (RSA) (Friborg et al., 2003) is a 37-item scale that measures resilience as healthy adaptation and personal competence during exposure to significant adversity, trauma, or stress.
Time Frame
T6-12 months later
Title
Post-concussion symptom-(T1)
Description
post-concussion will be measured by the Rivermead post-concussion symptom scale.
Time Frame
T1-Baseline
Title
Post-concussion symptom-(T2)
Description
post-concussion will be measured by the Rivermead post-concussion symptom scale.
Time Frame
T2-1 month later
Title
Post-concussion symptom-(T3)
Description
post-concussion will be measured by the Rivermead post-concussion symptom scale.
Time Frame
T3-2 months later
Title
Post-concussion symptom-(T4)
Description
post-concussion will be measured by the Rivermead post-concussion symptom scale.
Time Frame
T4-3 months later
Title
Post-concussion symptom-(T5)
Description
post-concussion will be measured by the Rivermead post-concussion symptom scale.
Time Frame
T5-6 months later
Title
Post-concussion symptom-(T6)
Description
post-concussion will be measured by the Rivermead post-concussion symptom scale.
Time Frame
T6-12 months later
Title
Self-efficacy-(T1)
Description
Self-efficacy will be measured by the self-efficacy scale.
Time Frame
T1- Baseline
Title
Self-efficacy-(T2)
Description
Self-efficacy will be measured by the self-efficacy scale.
Time Frame
T2- 1 month later
Title
Self-efficacy-(T3)
Description
Self-efficacy will be measured by the self-efficacy scale.
Time Frame
T3- 2 months later
Title
Self-efficacy-(T4)
Description
Self-efficacy will be measured by the self-efficacy scale.
Time Frame
T4- 3 months later
Title
Self-efficacy-(T5)
Description
Self-efficacy will be measured by the self-efficacy scale.
Time Frame
T5- 6 months later
Title
Self-efficacy-(T6)
Description
Self-efficacy will be measured by the self-efficacy scale.
Time Frame
T6- 12 months later
Title
Sleep quality-(T1)
Description
Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.
Time Frame
T1- Baseline
Title
Sleep quality-(T2)
Description
Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.
Time Frame
T2- 1 month later
Title
Sleep quality-(T3)
Description
Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.
Time Frame
T3- 2 months later
Title
Sleep quality-(T4)
Description
Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.
Time Frame
T4- 3 months later
Title
Sleep quality-(T5)
Description
Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.
Time Frame
T5- 6 months later
Title
Sleep quality-(T6)
Description
Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.
Time Frame
T6- 12 months later
Title
Sport motivation Scale-(T1)
Description
Sport motivation will be measure by the Sport Motivation Scale II (SMS-II)and exercise motivation interview. The 18-item SMS-II consists of six subscalesmeasuring amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic motivation. Each subscale has three items. Participants were asked to respond to all the items on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true).
Time Frame
T1- baseline
Title
Sport motivation Scale-(T2)
Description
Sport motivation will be measure by the Sport Motivation Scale II (SMS-II)and exercise motivation interview. The 18-item SMS-II consists of six subscalesmeasuring amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic motivation. Each subscale has three items. Participants were asked to respond to all the items on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true).
Time Frame
T2- 1 month later
Title
Sport motivation Scale-(T3)
Description
Sport motivation will be measure by the Sport Motivation Scale II (SMS-II)and exercise motivation interview. The 18-item SMS-II consists of six subscalesmeasuring amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic motivation. Each subscale has three items. Participants were asked to respond to all the items on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true).
Time Frame
T3- 2 month later
Title
Sport motivation Scale-(T4)
Description
Sport motivation will be measure by the Sport Motivation Scale II (SMS-II)and exercise motivation interview. The 18-item SMS-II consists of six subscalesmeasuring amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic motivation. Each subscale has three items. Participants were asked to respond to all the items on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true).
Time Frame
T4- 3 month later
Title
Sport motivation Scale-(T5)
Description
Sport motivation will be measure by the Sport Motivation Scale II (SMS-II)and exercise motivation interview. The 18-item SMS-II consists of six subscalesmeasuring amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic motivation. Each subscale has three items. Participants were asked to respond to all the items on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true).
Time Frame
T5- 6 month later
Title
Sport motivation Scale-(T6)
Description
Sport motivation will be measure by the Sport Motivation Scale II (SMS-II)and exercise motivation interview. The 18-item SMS-II consists of six subscalesmeasuring amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic motivation. Each subscale has three items. Participants were asked to respond to all the items on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true).
Time Frame
T6- 12 month later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Hsun Chiang, PhD
Phone
02-8792-6692
Ext
18761
Email
sheisvivian@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Hsun Chiang, PhD
Organizational Affiliation
National Defense Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
TSGH
City
Taipei city
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27814304
Citation
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.
Results Reference
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PubMed Identifier
12392797
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.
Results Reference
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PubMed Identifier
18425937
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.
Results Reference
background
PubMed Identifier
25755918
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.
Results Reference
background
PubMed Identifier
26165153
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.
Results Reference
background
PubMed Identifier
27216223
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.
Results Reference
background

Learn more about this trial

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

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