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AI Chatbot-Assisted Aerobic Exercise Guided by the Transtheoretical Model and Self-determination Theory With Machine Learning Algorithms to Provide Real-time, Personalized Feedback in Traumatic Brain Injury

2026년 8월 19일 업데이트: Hui-Hsun Chiang, National Defense Medical Center, Taiwan

Effects of an AI Chatbot-Assisted Aerobic Exercise Guided by the Transtheoretical Model and Self-determination Theory With Machine Learning Algorithms to Provide Real-time, Personalized Feedback on Health Outcomes in Patients With Traumatic Brain Injury

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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

  1. 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.

  2. Phase II : two-arm RCT (Aim 2) Phase I will focus on evaluating the functional capacity, sleep quality and depressive symptoms of the AI-PEF intervention in mTBI patient. A two-parallel-group design will be employed, with 50 participants, 25 participants per group, randomly assigned in a 1:1 ratio to the AI-PEF group and Active control group. Over three months, AI-PEF participants will engage in personalized exercise guided by AI, while active control participants will follow standard exercise recommendations. Both qualitative and quantitative data will be collected. Assessments will occur at baseline (T0), 1month (T1),2months(T2),and 3months(T3), including fitness tracker data, questionnaires (motivation, sleep, symptoms), and semi-structured interviews. The primary outcome will be functional capacity in mTBI patients, while secondary outcomes will focus on sleep quality and depressive symptoms in mTBI patients.
  3. Phase III : a waitlist two-arm RCT (Aim 3):Phase III will assess the long-term impact of the AI-PEF on health outcomes through a waitlist 2-arm RCT randomly assigned to one of two groups: (1) the AI-PEF group, receiving a machine learning-powered personalized exercise program; (2) the Active control group, receiving general exercise recommendations as part of standard care in a 1:1 ratio.(3)After three months, the Active control group will receive AI-PEF interventions to be the waitlist control group, with assessments conducted at 6 months (T4). Primary outcomes, including functional capacity in mTBI patients, while secondary outcomes will focus on sleep quality and depressive symptoms in mTBI patients.It will be assessed through standardized questionnaires and qualitative interviews. These standardized questionnaires are being used in our current digital remote exercise trial in patients with mild TBI (NSTC 112-2314-B-016-007-MY2) and have performed well on physiological performance. Data will be collected and analyzed using both quantitative and qualitative methods to compare health outcomes across the two groups, identifying the efficacy of AI-PEF relative to Active control group . Procedures will adhere to the blinding and randomization protocols described in Intervention Fidelity, ensuring unbiased assignment and data collection processes. This proposed study protocol is closely aligned with those that have been successfully implemented in our previous digital exercise trial.

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 대만
      • Taipei, 대만, 11490
        • 모병
        • Tri-Service General Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Eligible participants are patients aged over 18 with mild TBI (GCS 13-15)
  • who can walk independently,
  • reside in the Greater Taipei area,
  • and possess sufficient Chinese or Taiwanese language proficiency to understand the trial
  • complete self-administered questionnaires.

Exclusion Criteria:

include individuals with severe medical conditions (e.g., respiratory failure, epilepsy, psychiatric disorders), musculoskeletal or neurological impairments

  • hindering physical activity in the 6-minute walk test,
  • cognitive impairments (MMSE < 24),
  • frontal lobe injuries or penetrating injury causing significant psychological dysfunction.
  • Patients regularly engaging in moderate-to-high-intensity aerobic exercise or participating in other studies will also be excluded to avoid bias.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Ai-pef
기계 학습 구동 개인 개인 운동 프로그램을 수신하는 AI-PEF 그룹.
행동: AI-PEF
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.
활성 비교기: Active control group
the Active control group, receiving general exercise recommendations as part of standard care in a 1:1 ratio.
행동: Active Control
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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
6-Minute Walk Test
기간: T0-baseline
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.
T0-baseline
6-Minute Walk Test
기간: T1(1 month later)
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.
T1(1 month later)
6-Minute Walk Test
기간: T2(2 month later)
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.
T2(2 month later)
6-Minute Walk Test
기간: T3(3 month later)
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.
T3(3 month later)
6-Minute Walk Test
기간: T4(6 month later)
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.
T4(6 month later)
Adherence
기간: T0-baseline
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.
T0-baseline
Adherence
기간: T1(1 month later)
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.
T1(1 month later)
Adherence
기간: T2(2 month later)
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.
T2(2 month later)
Adherence
기간: T3(3 month later)
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.
T3(3 month later)
Adherence
기간: T4(6 month later)
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.
T4(6 month later)
The Chinese Version of the Sport Motivation Scale-II
기간: T0-baseline
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.
T0-baseline
The Chinese Version of the Sport Motivation Scale-II
기간: T1(1 month later)
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.
T1(1 month later)
The Chinese Version of the Sport Motivation Scale-II
기간: T2(2 month later)
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.
T2(2 month later)
The Chinese Version of the Sport Motivation Scale-II
기간: T3(3 month later)
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.
T3(3 month later)
The Chinese Version of the Sport Motivation Scale-II
기간: T4(6 month later)
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.
T4(6 month later)
The mHealth App usability questionnaire
기간: T0-baseline
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.
T0-baseline
The mHealth App usability questionnaire
기간: T1(1 month later)
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.
T1(1 month later)
The mHealth App usability questionnaire
기간: T2(2 month later)
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.
T2(2 month later)
The mHealth App usability questionnaire
기간: T3(3 month later)
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.
T3(3 month later)
The mHealth App usability questionnaire
기간: T4(6 month later)
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.
T4(6 month later)

2차 결과 측정

결과 측정
측정값 설명
기간
The Pittsburgh Sleep Quality Index
기간: T0-baseline
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.
T0-baseline
The Beck Depression Inventory-II
기간: T0-baseline
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.
T0-baseline
The Rivermead Post-Concussion Symptoms Questionnaire
기간: T0(baseline)
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
T0(baseline)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
기간: T0( baseline)
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.
T0( baseline)
The World Health Organization Quality of Life Scale-brief
기간: T0( baseline)
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.
T0( baseline)
Advanced sleep pattern
기간: T0(baseline)
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.
T0(baseline)
Mini-Mental State Examination
기간: T0( baseline)
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.
T0( baseline)
Montreal Cognitive Assessment
기간: T0(baseline)
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.
T0(baseline)
Near-Infrared Brain Blood Flow Imaging
기간: T0( baseline)
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.
T0( baseline)
Semi-Structured Interviews
기간: T0(baseline)
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.
T0(baseline)
The Pittsburgh Sleep Quality Index
기간: T1(1 month later)
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.
T1(1 month later)
The Pittsburgh Sleep Quality Index
기간: T2(2 month later)
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.
T2(2 month later)
The Pittsburgh Sleep Quality Index
기간: T3(3 month later)
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.
T3(3 month later)
The Pittsburgh Sleep Quality Index
기간: T4(6 month later)
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.
T4(6 month later)
The Beck Depression Inventory-II
기간: T1(1 month later)
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.
T1(1 month later)
The Beck Depression Inventory-II
기간: T2(2 month later)
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.
T2(2 month later)
The Beck Depression Inventory-II
기간: T3(3 month later)
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.
T3(3 month later)
The Beck Depression Inventory-II
기간: T4(6 month later)
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.
T4(6 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
기간: T1(1 month later)
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
T1(1 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
기간: T2(2 month later)
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
T2(2 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
기간: T3(3 month later)
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
T3(3 month later)
The Rivermead Post-Concussion Symptoms Questionnaire
기간: T4(6 month later)
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
T4(6 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
기간: T1(1 month later)
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.
T1(1 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
기간: T2(2 month later)
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.
T2(2 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
기간: T3(3 month later)
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.
T3(3 month later)
The Godin-Shephard Leisure Time Physical Activity Questionnaire
기간: T4(6 month later)
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.
T4(6 month later)
The World Health Organization Quality of Life Scale-brief
기간: T1(1 month later)
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.
T1(1 month later)
The World Health Organization Quality of Life Scale-brief
기간: T2(2 month later)
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.
T2(2 month later)
The World Health Organization Quality of Life Scale-brief
기간: T3(3 month later)
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.
T3(3 month later)
The World Health Organization Quality of Life Scale-brief
기간: T4(6 month later)
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.
T4(6 month later)
Mini-Mental State Examination
기간: T1(1 month later)
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.
T1(1 month later)
Mini-Mental State Examination
기간: T2(2 month later)
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.
T2(2 month later)
Mini-Mental State Examination
기간: T3(3 month later)
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.
T3(3 month later)
Mini-Mental State Examination
기간: T4(6 month later)
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.
T4(6 month later)
Montreal Cognitive Assessment
기간: T1(1 month later)
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.
T1(1 month later)
Montreal Cognitive Assessment
기간: T2(2 month later)
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.
T2(2 month later)
Montreal Cognitive Assessment
기간: T3(3 month later)
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.
T3(3 month later)
Montreal Cognitive Assessment
기간: T4(6 month later)
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.
T4(6 month later)
Near-Infrared Brain Blood Flow Imaging
기간: T1(1 month later)
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.
T1(1 month later)
Near-Infrared Brain Blood Flow Imaging
기간: T2(2 month later)
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.
T2(2 month later)
Near-Infrared Brain Blood Flow Imaging
기간: T3(3 month later)
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.
T3(3 month later)
Near-Infrared Brain Blood Flow Imaging
기간: T4(6 month later)
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.
T4(6 month later)
Semi-Structured Interviews
기간: T1(1 month later)
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.
T1(1 month later)
Semi-Structured Interviews
기간: T2(2 month later)
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.
T2(2 month later)
Semi-Structured Interviews
기간: T3(3 month later)
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.
T3(3 month later)
Semi-Structured Interviews
기간: T4(6 month later)
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.
T4(6 month later)
Physiological Monitoring Tools
기간: T1(1 month later)
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.
T1(1 month later)
Physiological Monitoring Tools
기간: T2(2 month later)
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.
T2(2 month later)
Physiological Monitoring Tools
기간: T3(3 month later)
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.
T3(3 month later)
Physiological Monitoring Tools
기간: T4(6 month later)
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.
T4(6 month later)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Defense Medical Center, Taiwan

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 8월 14일

기본 완료 (추정된)

2030년 12월 31일

연구 완료 (추정된)

2031년 8월 31일

연구 등록 날짜

최초 제출

2025년 5월 20일

QC 기준을 충족하는 최초 제출

2026년 8월 19일

처음 게시됨 (실제)

2026년 8월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 19일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • AI chatbot-assisted exercise

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다