An interventional study of AI-PEF and Active Control in Tramatic Brain Injury, sponsored by National Defense Medical Center, Taiwan. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by National Defense Medical Center, Taiwan · Not applicable, Interventional, and Supportive care
This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance health outcomes in mTBI patients.
Methods: AI-PEF integrates the transtheoretical model and self-determination theory with machine learning algorithms to provide real-time, personalized feedback. A phased randomized controlled trial will be conducted: Phase I,small-Scale Pilot Study (Early Feedback): A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity.Phase II assesses the program's impact on functional capacity, sleep quality and depressive symptoms, with 50 participants in a 2-arm randomized trial in 3 months.Phase III will assess the program's impact on functional capacity, sleep quality and depressive symptoms, with 50 participants of waitlist control evaluation in a two-arm randomized trial.
The study will employ a stepwise, multi-phase design, combining two-arm randomized controlled trial (RCT) to evaluate the functional capacity, sleep quality and depressive symptoms of the AI-PEF.Participants will be recruited from the neurosurgery clinics at Tri-Service General Hospital, Taipei. Recruitment will be facilitated through referrals by attending physicians and registered nurses, who will be briefed on the study protocol.
Study procedures
Phase I (Year 1): small-Scale Pilot Study (Early Feedback for aim 1):
A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 50 is above the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →National Defense Medical Center, Taiwan is the lead sponsor of 64 studies on the registry; 17 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
include individuals with severe medical conditions (e.g., respiratory failure, epilepsy, psychiatric disorders), musculoskeletal or neurological impairments
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the AI-PEF group, receiving a machine learning-powered personalized exercise program.
Behavioral: AI-PEF
the Active control group, receiving general exercise recommendations as part of standard care in a 1:1 ratio.
Behavioral: Active Control
Participants will follow a 6months walking program with five 30-minute sessions per week, progressively increasing intensity based on heart rate and effort indices. Garmin fitness trackers will monitor adherence and intensity. Remote guidance will support participants via weekly digital health messages on the LINE app, offering personalized feedback, goal reinforcement, and lifestyle recommendations. Participants will also receiThese AI feedback implementations will be tailored to complement the in-person education and will include reminders of the individualized goals set during the remote exercise intervention and consultation . The digital component will also offer a platform for patients to share their progress and seek further guidance during the scheduled in-person consultation. The use of digital AI feedback aligns with the trend of integrating technology into healthcare services, providing a convenient and accessible modality for supporting parents engaging in regular exercise.
Participants in the active control group will receive standard TBI care, including Garmin-based self-monitoring and routine clinic visits at baseline (T0), 1 months (T1), 2months(T2),and 3 months (T3). These visits will include general health education and recommendations on daily physical activity. No personalized or digital exercise strategies will be provided. Participants completing the 3-month protocol will have the option to access the AI-PEF program. When active control group participants completing the 3-month protocol will have the option to access the AI-PEF program.Then participants will use AI-PEF program to be the waitlist control group after 3 months to 6months, with assessments conducted at 6 months (T4).
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
Time frame: T0-baseline
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
Time frame: T1(1 month later)
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
Time frame: T2(2 month later)
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
Time frame: T3(3 month later)
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance(meter) indicates better functional capacity.
Time frame: T4(6 month later)
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Time frame: T0-baseline
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Time frame: T1(1 month later)
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Time frame: T2(2 month later)
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Time frame: T3(3 month later)
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Time frame: T4(6 month later)
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Time frame: T0-baseline
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Time frame: T1(1 month later)
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Time frame: T2(2 month later)
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Time frame: T3(3 month later)
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Time frame: T4(6 month later)
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Time frame: T0-baseline
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Time frame: T1(1 month later)
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Time frame: T2(2 month later)
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Time frame: T3(3 month later)
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Time frame: T4(6 month later)
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the Pittsburgh Sleep Quality Index Chinese version in Taiwan's populations. Each component score of the Pittsburgh Sleep Quality Index ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Time frame: T0-baseline
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), higher scores indicating more severe depressive symptoms,will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Time frame: T0-baseline
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms
Time frame: T0(baseline)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Time frame: T0( baseline)
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Time frame: T0( baseline)
Advanced sleep pattern
Garmin Vivosmart 5. This wearable device will track heart rate, exercise intensity, and sleep patterns. HR will be track every second. Advanced sleep tracking in compatible Garmin devices takes into account multiple factors to help understanding of sleep. In addition to the basics, such as when participants fell asleep and when they woke up, researchers can see times when they were awake and how much time they spent in key sleep stages (light, deep, REM), and the data will be calculated by heart rate to increase its validity.
Time frame: T0(baseline)
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Time frame: T0( baseline)
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Time frame: T0(baseline)
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Time frame: T0( baseline)
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data. It is a qualitative data, not a quantitative data. The interview content covers three major questions: (1) Benefits of the walking program; (2) Experiences and challenges of the walking program; (3) The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Time frame: T0(baseline)
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the Pittsburgh Sleep Quality Index Chinese version in Taiwan's populations. Each component score of the Pittsburgh Sleep Quality Index ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Time frame: T1(1 month later)
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the Pittsburgh Sleep Quality Index Chinese version in Taiwan's populations. Each component score of the Pittsburgh Sleep Quality Index ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Time frame: T2(2 month later)
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the Pittsburgh Sleep Quality Index Chinese version in Taiwan's populations. Each component score of the Pittsburgh Sleep Quality Index ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Time frame: T3(3 month later)
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the Pittsburgh Sleep Quality Index Chinese version in Taiwan's populations. Each component score of the Pittsburgh Sleep Quality Index ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Time frame: T4(6 month later)
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), higher scores indicating more severe depressive symptoms,will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Time frame: T1(1 month later)
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), higher scores indicating more severe depressive symptoms,will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Time frame: T2(2 month later)
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), higher scores indicating more severe depressive symptoms,will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Time frame: T3(3 month later)
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), higher scores indicating more severe depressive symptoms,will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Time frame: T4(6 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms
Time frame: T1(1 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms
Time frame: T2(2 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms
Time frame: T3(3 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms
Time frame: T4(6 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Time frame: T1(1 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Time frame: T2(2 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Time frame: T3(3 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Time frame: T4(6 month later)
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Time frame: T1(1 month later)
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Time frame: T2(2 month later)
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Time frame: T3(3 month later)
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Time frame: T4(6 month later)
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Time frame: T1(1 month later)
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Time frame: T2(2 month later)
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Time frame: T3(3 month later)
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Time frame: T4(6 month later)
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Time frame: T1(1 month later)
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Time frame: T2(2 month later)
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Time frame: T3(3 month later)
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Time frame: T4(6 month later)
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Time frame: T1(1 month later)
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Time frame: T2(2 month later)
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Time frame: T3(3 month later)
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Time frame: T4(6 month later)
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data. It is a qualitative data, not a quantitative data. The interview content covers three major questions: (1) Benefits of the walking program; (2) Experiences and challenges of the walking program; (3) The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Time frame: T1(1 month later)
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data. It is a qualitative data, not a quantitative data. The interview content covers three major questions: (1) Benefits of the walking program; (2) Experiences and challenges of the walking program; (3) The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Time frame: T2(2 month later)
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data. It is a qualitative data, not a quantitative data. The interview content covers three major questions: (1) Benefits of the walking program; (2) Experiences and challenges of the walking program; (3) The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Time frame: T3(3 month later)
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data. It is a qualitative data, not a quantitative data. The interview content covers three major questions: (1) Benefits of the walking program; (2) Experiences and challenges of the walking program; (3) The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Time frame: T4(6 month later)
Physiological Monitoring Tools
Participants will wear a Garmin Vivosmart 5 device during the intervention period. The device will be used to collect heart rate, physical activity, exercise intensity, and sleep-related data. Data will be synchronized with the Garmin Connect application for monitoring and data collection. Heart rate data will be recorded continuously during device use. Sleep-related variables estimated by the device include total sleep time, awake time, light sleep duration, deep sleep duration, and rapid eye movement sleep duration. Each variable will be reported separately in its corresponding outcome measure.
Time frame: T1(1 month later)
Physiological Monitoring Tools
Participants will wear a Garmin Vivosmart 5 device during the intervention period. The device will be used to collect heart rate, physical activity, exercise intensity, and sleep-related data. Data will be synchronized with the Garmin Connect application for monitoring and data collection. Heart rate data will be recorded continuously during device use. Sleep-related variables estimated by the device include total sleep time, awake time, light sleep duration, deep sleep duration, and rapid eye movement sleep duration. Each variable will be reported separately in its corresponding outcome measure.
Time frame: T2(2 month later)
Physiological Monitoring Tools
Participants will wear a Garmin Vivosmart 5 device during the intervention period. The device will be used to collect heart rate, physical activity, exercise intensity, and sleep-related data. Data will be synchronized with the Garmin Connect application for monitoring and data collection. Heart rate data will be recorded continuously during device use. Sleep-related variables estimated by the device include total sleep time, awake time, light sleep duration, deep sleep duration, and rapid eye movement sleep duration. Each variable will be reported separately in its corresponding outcome measure.
Time frame: T3(3 month later)
Physiological Monitoring Tools
Participants will wear a Garmin Vivosmart 5 device during the intervention period. The device will be used to collect heart rate, physical activity, exercise intensity, and sleep-related data. Data will be synchronized with the Garmin Connect application for monitoring and data collection. Heart rate data will be recorded continuously during device use. Sleep-related variables estimated by the device include total sleep time, awake time, light sleep duration, deep sleep duration, and rapid eye movement sleep duration. Each variable will be reported separately in its corresponding outcome measure.
Time frame: T4(6 month later)
Plan to share: No
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National Defense Medical Center, Taiwan