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Completed

NCT Number: NCT04243226

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

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.

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Key information

Conditions

Cardiology Psychiatry

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TSGH

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

telehealth-based aerobic walking exercise

Device

The aim of this study is to develop exercise prescription of TBI patients and then to evaluate the effectiveness of programmed aerobic exercise to improve psysical-psycho-social health such as cognitive status, 6 minutes walk test, depression relief, motivation, symptom, resilience and quality of life.

Other names: aerobic exercise, walking exercise, theoretical-based aerobic exercise, walking

Primary outcomes

  1. cerebral blood flow (CBF)-(T1)

    Time frame: T1_Baseline

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

  2. cerebral blood flow (CBF)-(T2)

    Time frame: T2_1 month later

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

  3. cerebral blood flow (CBF)-(T3)

    Time frame: T3_2 months later

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

  4. cerebral blood flow (CBF)-(T4)

    Time frame: T4_3 months later

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

  5. cerebral blood flow (CBF)-(T5)

    Time frame: T5_6 months later

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

  6. cerebral blood flow (CBF)-(T6)

    Time frame: T6_12 months later

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

  7. 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.

  8. 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.

  9. 6 minutes walk test-(T3)

    Time frame: T3-2 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.

  10. 6 minutes walk test-(T4)

    Time frame: T4-3 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.

  11. 6 minutes walk test-(T5)

    Time frame: T5-6 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.

  12. 6 minutes walk test-(T6)

    Time frame: T6-12 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.

  13. 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.

  14. 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.

  15. Cardio force index (CFI)-(T3)

    Time frame: T3-2 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.

  16. Cardio force index (CFI)-(T4)

    Time frame: T4-3 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.

  17. Cardio force index (CFI)-(T5)

    Time frame: T5-6 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.

  18. Cardio force index (CFI)-(T6)

    Time frame: T6-12 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 outcomes

  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: T3-2month 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: T4-3month 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. Cognitive function-(T5)

    Time frame: T5-6months 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.

  6. Cognitive function-(T6)

    Time frame: T6-12months 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.

  7. 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.

  8. 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 outcomes

  1. depression status-(T1)

    Time frame: T1-Baseline

    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.

  2. depression status-(T2)

    Time frame: T2-1 month later

    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.

  3. depression status-(T3)

    Time frame: T3-2 months later

    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.

  4. depression status-(T4)

    Time frame: T4-3 months later

    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.

  5. depression status-(T5)

    Time frame: T5-6 months later

    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.

  6. depression status-(T6)

    Time frame: T6-12 months later

    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.

  7. 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.

  8. 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.

  9. Quality of life-(T3): WHOQOL-BREF

    Time frame: T3-2 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.

  10. Quality of life-(T4): WHOQOL-BREF

    Time frame: T4-3 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.

  11. Quality of life-(T5): WHOQOL-BREF

    Time frame: T5- 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.

  12. Quality of life-(T6): WHOQOL-BREF

    Time frame: T6- 12 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.

  13. 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.

  14. 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.

  15. resilience status-(T3)

    Time frame: T3-2 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.

  16. resilience status-(T4)

    Time frame: T4-3 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.

  17. resilience status-(T5)

    Time frame: T5-6 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.

  18. resilience status-(T6)

    Time frame: T6-12 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.

  19. Post-concussion symptom-(T1)

    Time frame: T1-Baseline

    post-concussion will be measured by the Rivermead post-concussion symptom scale.

  20. Post-concussion symptom-(T2)

    Time frame: T2-1 month later

    post-concussion will be measured by the Rivermead post-concussion symptom scale.

  21. Post-concussion symptom-(T3)

    Time frame: T3-2 months later

    post-concussion will be measured by the Rivermead post-concussion symptom scale.

  22. Post-concussion symptom-(T4)

    Time frame: T4-3 months later

    post-concussion will be measured by the Rivermead post-concussion symptom scale.

  23. Post-concussion symptom-(T5)

    Time frame: T5-6 months later

    post-concussion will be measured by the Rivermead post-concussion symptom scale.

  24. Post-concussion symptom-(T6)

    Time frame: T6-12 months later

    post-concussion will be measured by the Rivermead post-concussion symptom scale.

  25. Self-efficacy-(T1)

    Time frame: T1- Baseline

    Self-efficacy will be measured by the self-efficacy scale.

  26. Self-efficacy-(T2)

    Time frame: T2- 1 month later

    Self-efficacy will be measured by the self-efficacy scale.

  27. Self-efficacy-(T3)

    Time frame: T3- 2 months later

    Self-efficacy will be measured by the self-efficacy scale.

  28. Self-efficacy-(T4)

    Time frame: T4- 3 months later

    Self-efficacy will be measured by the self-efficacy scale.

  29. Self-efficacy-(T5)

    Time frame: T5- 6 months later

    Self-efficacy will be measured by the self-efficacy scale.

  30. Self-efficacy-(T6)

    Time frame: T6- 12 months later

    Self-efficacy will be measured by the self-efficacy scale.

  31. Sleep quality-(T1)

    Time frame: T1- Baseline

    Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.

  32. Sleep quality-(T2)

    Time frame: T2- 1 month later

    Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.

  33. Sleep quality-(T3)

    Time frame: T3- 2 months later

    Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.

  34. Sleep quality-(T4)

    Time frame: T4- 3 months later

    Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.

  35. Sleep quality-(T5)

    Time frame: T5- 6 months later

    Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.

  36. Sleep quality-(T6)

    Time frame: T6- 12 months later

    Sleep quality will be measured by the Pittsburgh sleep quality scale and the Garmin vivosmart sleep records and its physiological recording.

  37. Sport motivation Scale-(T1)

    Time frame: T1- baseline

    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).

  38. Sport motivation Scale-(T2)

    Time frame: T2- 1 month later

    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).

  39. Sport motivation Scale-(T3)

    Time frame: T3- 2 month later

    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).

  40. Sport motivation Scale-(T4)

    Time frame: T4- 3 month later

    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).

  41. Sport motivation Scale-(T5)

    Time frame: T5- 6 month later

    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).

  42. Sport motivation Scale-(T6)

    Time frame: T6- 12 month later

    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).

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2020
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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