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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243226
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hui-Hsun Chiang, National Defense Medical Center, Taiwan

Brief Summary:
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 cognitive performance, depression relief and quality of life with improvement of CBF. This will be a three-year study, with the first two year using a mixed method to explore the feasibility of such a safety exercise prescription. In the second to third year, a randomized clinical control trial will be applied in TBI patients to evaluate the effectiveness of programmed aerobic exercise to promote cognitive status, 6 minutes walk test, depression relief and quality of life.

Condition or disease Intervention/treatment Phase
Cardiology Psychiatry Device: cerebral blood flow (CBF) through aerobic exercise Not Applicable

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 cognitive, depression relief and mental health of TBI patients. 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 and its mediation effect of CBF based on the PI's research 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 cognitive performance, depression relief and quality of life with improvement of CBF. This will be a three-year study, with the first two year using a mixed method to explore the feasibility of such a safety exercise prescription. In the second to third year, a randomized clinical control trial will be applied in TBI patients to evaluate the effectiveness of programmed aerobic exercise to promote cognitive status, 6 minutes walk test, depression relief and quality of life.

During the first two years, 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 cognition function, quality of life and depression status. 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 second year. 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, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Participant)
Masking Description:
  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.
Primary Purpose: Supportive Care
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
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: this study is to develop exercise prescription of TBI patients
The aim of this study is to develop exercise prescription of TBI patients and then to evaluate the effectiveness of programmed aerobic exercise to improve cognitive performance, depression relief and quality of life with improvement of CBF. This will be a three-year study, with the first two year using a mixed method to explore the feasibility of such a safety exercise prescription. In the second to third year, a randomized clinical control trial will be applied in TBI patients to evaluate the effectiveness of programmed aerobic exercise to promote cognitive status, 6 minutes walk test, depression relief and quality of life.
Device: cerebral blood flow (CBF) through aerobic exercise
The aim of this study is to develop exercise prescription of TBI patients and then to evaluate the effectiveness of programmed aerobic exercise to improve cognitive performance, depression relief and quality of life with improvement of CBF
Other Name: aerobic exercise

No Intervention: No exercise prescription in TBI patients
Routine Care of TBI Patients



Primary Outcome Measures :
  1. cerebral blood flow (CBF)-(T1) [ Time Frame: T1_Baseline ]
    Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B

  2. cerebral blood flow (CBF)-(T2) [ Time Frame: T2_1 month later ]
    Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B

  3. cerebral blood flow (CBF)-(T3) [ Time Frame: T3_3 months later ]
    Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B

  4. cerebral blood flow (CBF)-(T4) [ Time Frame: T4_6 months later ]
    Hemoencephalography (HEG) will be measure by Bioland, the unit is ratio A/B

  5. 6 minutes walk test-(T1) [ Time Frame: T1-Baseline ]
    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. 6 minutes walk test-(T2) [ Time Frame: T2-1 month later ]
    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.

  7. 6 minutes walk test-(T3) [ Time Frame: T3-3 months later ]
    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.

  8. 6 minutes walk test-(T4) [ Time Frame: T4-6 months later ]
    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.

  9. Cardio force index (CFI)-(T1) [ Time Frame: T1-Baseline ]
    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.

  10. Cardio force index (CFI)-(T2) [ Time Frame: T2-1 month later ]
    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.

  11. Cardio force index (CFI)-(T3) [ Time Frame: T3-3 months later ]
    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.

  12. Cardio force index (CFI)-(T4) [ Time Frame: T4-6 months later ]
    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 :
  1. Cognitive function-(T1) [ Time Frame: T1-Baseline ]
    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.

  2. Cognitive function-(T2) [ Time Frame: T2-1month later ]
    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.

  3. Cognitive function-(T3) [ Time Frame: T3-3months later ]
    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.

  4. Cognitive function-(T4) [ Time Frame: T4-6months later ]
    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.

  5. Brain single photon emission computed tomography (SPECT)-(T1) [ Time Frame: T1_Baseline ]
    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.

  6. Brain single photon emission computed tomography (SPECT)-(T4) [ Time Frame: T4_6 months later ]
    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.


Other Outcome Measures:
  1. depression status-(T1) [ Time Frame: T1-Baseline ]
    Depression will be measured by Center for Epidemiologic Studies - Depression Scale (CES-D) scale-10 items. The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. 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 20-item scale is 0 to 60, and a cut off score of 16 or higher indicates the presence of significant depressive symptoms.

  2. depression status-(T2) [ Time Frame: T2-1 month later ]
    Depression will be measured by Center for Epidemiologic Studies - Depression Scale (CES-D) scale-10 items. The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. 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 20-item scale is 0 to 60, and a cut off score of 16 or higher indicates the presence of significant depressive symptoms.

  3. depression status-(T3) [ Time Frame: T3-3 months later ]
    Depression will be measured by Center for Epidemiologic Studies - Depression Scale (CES-D) scale-10 items. The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. 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 20-item scale is 0 to 60, and a cut off score of 16 or higher indicates the presence of significant depressive symptoms.

  4. depression status-(T4) [ Time Frame: T4-6 months later ]
    Depression will be measured by Center for Epidemiologic Studies - Depression Scale (CES-D) scale-10 items. The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. 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 20-item scale is 0 to 60, and a cut off score of 16 or higher indicates the presence of significant depressive symptoms.

  5. Quality of life-(T1): WHOQOL-BREF [ Time Frame: T1-Baseline ]
    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.

  6. Quality of life-(T2): WHOQOL-BREF [ Time Frame: T2-1 month later ]
    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.

  7. Quality of life-(T3): WHOQOL-BREF [ Time Frame: T3-3 months later ]
    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.

  8. Quality of life-(T4): WHOQOL-BREF [ Time Frame: T4- 6 months later ]
    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.

  9. resilience status-(T1) [ Time Frame: T1-Baseline ]
    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.

  10. resilience status-(T2) [ Time Frame: T2-1 month later ]
    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.

  11. resilience status-(T3) [ Time Frame: T2-3 months later ]
    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.

  12. resilience status-(T4) [ Time Frame: T2-6 months later ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243226


Contacts
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Contact: Hui-Hsun Chiang, PhD 02-8792-6692 ext 18761 sheisvivian@gmail.com

Locations
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Taiwan
TSGH
Taipei city, Taiwan
Sponsors and Collaborators
National Defense Medical Center, Taiwan
Investigators
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Principal Investigator: Hui-Hsun Chiang, PhD National Defense Medical Center
Publications:
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Responsible Party: Hui-Hsun Chiang, Associate Professor, RN, PhD, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier: NCT04243226    
Other Study ID Numbers: 30988
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui-Hsun Chiang, National Defense Medical Center, Taiwan:
physical health care
Activity of Daily Living,ADL
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries