AI-driven Personalized Exercise Feedback Program on Exercise Adherence in Traumatic Brain Injury

August 13, 2026 updated by: Hui-Hsun Chiang, National Defense Medical Center, Taiwan

Effects of an AI-driven Personalized Exercise Feedback Program on Exercise Adherence and 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 exercise adherence and 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 evaluates feasibility and acceptability through Delphi methods with expert consensus and patient feedback; Phase II validates preliminary outcomes with 30 participants in a 2-arm randomized trial; and Phase III assesses the program's impact on exercise adherence, exercise motivation, mHealth app usability, functional capacity, sleep quality, depressive symptoms, concussion symptoms, and quality of life with 90 participants in a 3-arm randomized trial. In Phase III, quantitative and qualitative data will be collected in parallel, with qualitative data collected through semi-structured interviews to explore participants' experiences and perceptions of the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will employ a stepwise, multi-phase design, combining a two- parallel-group pilot study and a three-arm randomized controlled trial (RCT) to evaluate the appropriateness, feasibility, acceptability, and effectiveness of the AI-PEF (Figure 5). 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): Development and Pilot Testing (Aim 1) Phase I will focus on developing and refining the AI-PEF through expert validation and pilot testing. This phase will use a sequential-parallel hybrid design to develop and evaluate the appropriateness of the AI-PEF to deliver personalized exercise empowerment. Stage 1, Delphi Process for AI-PEF Development: Ten experts from diverse fields will participate in two Delphi rounds to finalize the AI-PEF framework. This includes refining algorithms, educational materials, and preliminary validation of key components, such as personalization algorithms and behavior-change strategies. Stage 2, 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.
  2. Phase II : Larger Pilot Study (Aim 2) Phase II will focus on evaluating the feasibility, acceptability, and preliminary effectiveness of the refined AI-PEF intervention. A two-parallel-group design will be employed, with 30 participants, 15 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) and 3 months (T1), including fitness tracker data, questionnaires (motivation, sleep, symptoms), and semi-structured interviews. The primary outcome of interest will be adherence rates, while secondary outcomes will focus on motivation and various health metrics.
  3. Phase III : Full- scale three-arm RCT (Aim 3) Phase III will assess the long-term impact of the AI-PEF on exercise adherence, motivation, and health outcomes through a 3-arm RCT, in which participants will be randomly assigned in a 1:1:1 ratio to one of three groups: (1) the AI-PEF group, receiving a machine learning-powered personalized exercise program; (2) the Theory-based digital exercise group, engaging in structured digital exercise without machine learning-powered feedback; or (3) the Active control group, receiving general exercise recommendations as part of standard care. Participants will receive group-specific interventions during the 12-week intervention period and will be followed for six months, with assessments conducted at baseline (T1), 1 month (T2), 2 months (T3), 3 months (T4), and the 6-month follow-up (T5).

Primary outcomes will include exercise adherence, exercise motivation, mHealth app usability, and functional capacity. Exercise adherence will be objectively measured via Garmin fitness trackers; exercise motivation and mHealth app usability will be assessed through standardized questionnaires; and functional capacity will be evaluated using the 6-Minute Walk Test. Secondary outcomes, such as sleep quality, depressive symptoms, concussion symptoms, and quality of life, will also be assessed through standardized questionnaires. 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 demonstrated good psychometric performance.

Quantitative and qualitative data will be collected and analyzed in parallel.Quantitative data will be used to compare adherence, motivation, usability, functional capacity, and health outcomes across the three groups and to evaluate the efficacy of AI-PEF relative to standard interventions. Qualitative interviews will explore participants' experiences and perceptions of the intervention. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AI-PEF
the AI-PEF group, receiving a machine learning-powered personalized exercise program.
Behavioral: AI-PEF
Participants will follow a 12-week walking program with at least three 30-minute sessions per week, with exercise intensity progressively adjusted based on heart rate and effort indices. Garmin fitness trackers will monitor exercise adherence and intensity. Remote guidance will be provided through five AI-generated digital health messages per week via LINE, delivered on Monday, Tuesday, Thursday, Friday, and Saturday, and tailored to participants' exercise performance and individualized goals established during the remote exercise intervention and consultation. The messages will include exercise performance feedback, goal setting and reinforcement, exercise and device-use reminders, health education, and encouragement and support. The digital component will allow participants to share their progress and seek guidance during scheduled in-person consultations. AI-driven digital feedback provides a convenient and accessible approach to supporting participants in engaging in exercise.
Experimental: Theory-based digital exercise
Theory-based digital exercise group, engaging in structured digital exercise without machine learning- powered feedback.
Behavioral: Theory-based digital exercise
The theory-based digital exercise group will follow the same in-person clinic visits, assessment schedule, and 12-week walking program as the AI-PEF group. Garmin fitness trackers will be used to monitor exercise adherence and intensity. The research team will deliver five standardized digital health messages per week through the LINE app using message templates developed in advance. The messages will include exercise guidance, goal setting and reinforcement, exercise and device-use reminders, health education and lifestyle recommendations, and encouragement and support. The messages will not be generated or tailored by AI, and participants will not receive AI-driven personalized feedback.
Active Comparator: Active control group
the Active control group, receiving general exercise recommendations as part of standard care in a 1:1:1 ratio.
Behavioral: Active Control
Participants in the active control group will receive standard TBI care, including routine clinic visits. In addition, Garmin fitness trackers will be provided for self-monitoring during the study. The research team will deliver five standardized general health messages per week through the LINE app. The messages will include TBI-related health education, general health and lifestyle information, general recommendations for daily physical activity, general check-in messages, and technical reminders for Garmin use. The messages will not include structured exercise guidance, individualized goal setting or reinforcement, performance-based feedback, or AI-generated personalized feedback. Participants completing the 6-month protocol will have the option to access the AI-PEF program after the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: T1-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.
T1-baseline
Adherence
Time Frame: T2- 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.
T2- 1 month later
Adherence
Time Frame: T3- 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.
T3- 2 month later
Adherence
Time Frame: T4- 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.
T4- 3 month later
Adherence
Time Frame: T5- 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.
T5- 6 month later
The Chinese Version of the Sport Motivation Scale-II
Time Frame: T1- 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.
T1- baseline
The Chinese Version of the Sport Motivation Scale-II
Time Frame: T2- 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.
T2- 1 month later
The Chinese Version of the Sport Motivation Scale-II
Time Frame: T3- 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.
T3- 2 month later
The Chinese Version of the Sport Motivation Scale-II
Time Frame: T4- 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.
T4- 3 month later
The Chinese Version of the Sport Motivation Scale-II
Time Frame: T5- 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.
T5- 6 month later
The mHealth App usability questionnaire
Time Frame: T1- 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.
T1- baseline
The mHealth App usability questionnaire
Time Frame: T2- 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.
T2- 1 month later
The mHealth App usability questionnaire
Time Frame: T3- 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.
T3- 2 month later
The mHealth App usability questionnaire
Time Frame: T4- 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.
T4- 3 month later
The mHealth App usability questionnaire
Time Frame: T5- 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.
T5- 6 month later
6-Minute Walk Test
Time Frame: T1- 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 indicates better functional capacity.
T1- baseline
6-Minute Walk Test
Time Frame: T2- 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 indicates better functional capacity.
T2- 1 month later
6-Minute Walk Test
Time Frame: T3- 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 indicates better functional capacity.
T3- 2 month later
6-Minute Walk Test
Time Frame: T4- 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 indicates better functional capacity.
T4- 3 month later
6-Minute Walk Test
Time Frame: T5- 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 indicates better functional capacity.
T5- 6 month later

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Pittsburgh Sleep Quality Index
Time Frame: T1-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 PSQI Chinese version in Taiwan's populations. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
T1-baseline
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time Frame: T1 -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.
T1 -baseline
The World Health Organization Quality of Life Scale-brief
Time Frame: T1 - 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.
T1 - baseline
Mini-Mental State Examination
Time Frame: T1- 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.
T1- baseline
Montreal Cognitive Assessment
Time Frame: T1-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.
T1-baseline
Near-Infrared Brain Blood Flow Imaging
Time Frame: T1 - 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.
T1 - baseline
cardiac metabolic performance benchmark
Time Frame: T1- baseline
Preliminary findings from this study applied the cardiac metabolic performance benchmark (CMPB3) to compare the effectiveness of increasing cerebral blood circulation at different intensities (CMPB3 ≤ 35, 40, 45, 50). Results indicated that CMPB3 levels above 40 effectively increased cerebral blood circulation, with improvements observed not only during exercise but also during the post-exercise rest period, where cerebral blood flow remained higher than the baseline level. The lower intensity means the lower exercise intensity and the higher ability to perform aerobic walking exercise. The benchmark will be calculated by the Heart rate measured by Garmin fitness bracelet.
T1- baseline
Semi-Structured Interviews
Time Frame: T1- 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 themes:

  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- baseline
The Beck Depression Inventory-II
Time Frame: T4-3 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), will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
T4-3 month later
The Beck Depression Inventory-II
Time Frame: T5- 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), will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
T5- 6 month later
The Pittsburgh Sleep Quality Index
Time Frame: T2- 1 month later
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version [68]. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the PSQI Chinese version in Taiwan's populations. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
T2- 1 month later
The Pittsburgh Sleep Quality Index
Time Frame: T3-2 month later
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version [68]. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the PSQI Chinese version in Taiwan's populations. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
T3-2 month later
The Pittsburgh Sleep Quality Index
Time Frame: T4-3 month later
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version [68]. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the PSQI Chinese version in Taiwan's populations. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
T4-3 month later
The Pittsburgh Sleep Quality Index
Time Frame: T5-6 month later
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version [68]. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the PSQI Chinese version in Taiwan's populations. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
T5-6 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time Frame: T2 -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 .
T2 -1 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time Frame: T3 -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.
T3 -2 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time Frame: T4-3 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.
T4-3 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time Frame: T5-6 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.
T5-6 month later
The World Health Organization Quality of Life Scale-brief
Time Frame: T2 - 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.
T2 - 1 month later
The World Health Organization Quality of Life Scale-brief
Time Frame: T3 - 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.
T3 - 2 month later
The World Health Organization Quality of Life Scale-brief
Time Frame: T4 - 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.
T4 - 3 month later
The World Health Organization Quality of Life Scale-brief
Time Frame: T5- 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.
T5- 6 month later
Mini-Mental State Examination
Time Frame: T2-1 month later
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds [75]. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury [76]. 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.
T2-1 month later
Mini-Mental State Examination
Time Frame: T3-2 month later
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds [75]. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury [76]. 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.
T3-2 month later
Mini-Mental State Examination
Time Frame: T4-3 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.
T4-3 month later
Mini-Mental State Examination
Time Frame: T5- 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.
T5- 6 month later
Montreal Cognitive Assessment
Time Frame: T2-1 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.
T2-1 month later
Montreal Cognitive Assessment
Time Frame: T3-2 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.
T3-2 month later
Montreal Cognitive Assessment
Time Frame: T4-3 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.
T4-3 month later
Montreal Cognitive Assessment
Time Frame: T5-6 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.
T5-6 month later
Near-Infrared Brain Blood Flow Imaging
Time Frame: T2- 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.
T2- 1 month later
Near-Infrared Brain Blood Flow Imaging
Time Frame: T3-2 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.
T3-2 month later
Near-Infrared Brain Blood Flow Imaging
Time Frame: T4- 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.
T4- 3 month later
Near-Infrared Brain Blood Flow Imaging
Time Frame: T5- 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.
T5- 6 month later
cardiac metabolic performance benchmark
Time Frame: T2- 1 month later
Preliminary findings from this study applied the cardiac metabolic performance benchmark (CMPB3) to compare the effectiveness of increasing cerebral blood circulation at different intensities (CMPB3 ≤ 35, 40, 45, 50). Results indicated that CMPB3 levels above 40 effectively increased cerebral blood circulation, with improvements observed not only during exercise but also during the post-exercise rest period, where cerebral blood flow remained higher than the baseline level. The lower intensity means the lower exercise intensity and the higher ability to perform aerobic walking exercise.
T2- 1 month later
cardiac metabolic performance benchmark
Time Frame: T3-2 month later
Preliminary findings from this study applied the cardiac metabolic performance benchmark (CMPB3) to compare the effectiveness of increasing cerebral blood circulation at different intensities (CMPB3 ≤ 35, 40, 45, 50). Results indicated that CMPB3 levels above 40 effectively increased cerebral blood circulation, with improvements observed not only during exercise but also during the post-exercise rest period, where cerebral blood flow remained higher than the baseline level. The lower intensity means the lower exercise intensity and the higher ability to perform aerobic walking exercise.
T3-2 month later
cardiac metabolic performance benchmark
Time Frame: T4- 3 month later
Preliminary findings from this study applied the cardiac metabolic performance benchmark (CMPB3) to compare the effectiveness of increasing cerebral blood circulation at different intensities (CMPB3 ≤ 35, 40, 45, 50). Results indicated that CMPB3 levels above 40 effectively increased cerebral blood circulation, with improvements observed not only during exercise but also during the post-exercise rest period, where cerebral blood flow remained higher than the baseline level. The lower intensity means the lower exercise intensity and the higher ability to perform aerobic walking exercise.
T4- 3 month later
cardiac metabolic performance benchmark
Time Frame: T5- 6 month later
Preliminary findings from this study applied the cardiac metabolic performance benchmark (CMPB3) to compare the effectiveness of increasing cerebral blood circulation at different intensities (CMPB3 ≤ 35, 40, 45, 50). Results indicated that CMPB3 levels above 40 effectively increased cerebral blood circulation, with improvements observed not only during exercise but also during the post-exercise rest period, where cerebral blood flow remained higher than the baseline level. The lower intensity means the lower exercise intensity and the higher ability to perform aerobic walking exercise.
T5- 6 month later
Semi-Structured Interviews
Time Frame: T2- 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 themes:

  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- 1 month later
Semi-Structured Interviews
Time Frame: T3- 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 themes:

  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- 2 month later
Semi-Structured Interviews
Time Frame: T4-3 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 themes:

  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.
T4-3 month later
Semi-Structured Interviews
Time Frame: T5- 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 themes:

  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.
T5- 6 month later
The Rivermead Post-Concussion Symptoms Questionnaire
Time Frame: T1- 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.
T1- baseline
The Rivermead Post-Concussion Symptoms Questionnaire
Time Frame: T2- 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.
T2- 1 month later
The Rivermead Post-Concussion Symptoms Questionnaire
Time Frame: T3- 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.
T3- 2 month later
The Rivermead Post-Concussion Symptoms Questionnaire
Time Frame: T4- 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.
T4- 3 month later
The Rivermead Post-Concussion Symptoms Questionnaire
Time Frame: T5- 6 month
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.
T5- 6 month
The Beck Depression Inventory-II
Time Frame: T1- 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), will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
T1- baseline
The Beck Depression Inventory-II
Time Frame: T2-1 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), will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
T2-1 month later
The Beck Depression Inventory-II
Time Frame: T3- 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), will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
T3- 2 month later
Physiological Monitoring Tools
Time Frame: T1- baseline
Garmin Vivosmart 5. This wearable device will track heart rate, exercise frequency, exercise duration, exercise intensity, step count, and sleep data. Data will be integrated with the Garmin Connect app for real-time monitoring and feedback. A preliminary study conducted by our research team in 2020 showed a high correlation (r = 0.91) between heart rate measurements obtained from the Garmin Vivosmart and the Zephyr BioHarness, supporting its use for home-based heart rate monitoring. Participants will wear the device at home to facilitate real-time tracking of exercise intensity and physiological responses during the intervention. Advanced sleep tracking in compatible Garmin devices incorporates multiple factors to provide information on sleep patterns. In addition to basic information, such as sleep onset and wake-up time, researchers will be able to obtain data on periods of wakefulness and time spent in key sleep stages, including light, deep, and rapid eye movement (REM) sleep.
T1- baseline
Physiological Monitoring Tools
Time Frame: T2- 1 month later
Garmin Vivosmart 5. This wearable device will track heart rate, exercise frequency, exercise duration, exercise intensity, step count, and sleep data. Data will be integrated with the Garmin Connect app for real-time monitoring and feedback. A preliminary study conducted by our research team in 2020 showed a high correlation (r = 0.91) between heart rate measurements obtained from the Garmin Vivosmart and the Zephyr BioHarness, supporting its use for home-based heart rate monitoring. Participants will wear the device at home to facilitate real-time tracking of exercise intensity and physiological responses during the intervention. Advanced sleep tracking in compatible Garmin devices incorporates multiple factors to provide information on sleep patterns. In addition to basic information, such as sleep onset and wake-up time, researchers will be able to obtain data on periods of wakefulness and time spent in key sleep stages, including light, deep, and rapid eye movement (REM) sleep.
T2- 1 month later
Physiological Monitoring Tools
Time Frame: T3-2 month later
Garmin Vivosmart 5. This wearable device will track heart rate, exercise frequency, exercise duration, exercise intensity, step count, and sleep data. Data will be integrated with the Garmin Connect app for real-time monitoring and feedback. A preliminary study conducted by our research team in 2020 showed a high correlation (r = 0.91) between heart rate measurements obtained from the Garmin Vivosmart and the Zephyr BioHarness, supporting its use for home-based heart rate monitoring. Participants will wear the device at home to facilitate real-time tracking of exercise intensity and physiological responses during the intervention. Advanced sleep tracking in compatible Garmin devices incorporates multiple factors to provide information on sleep patterns. In addition to basic information, such as sleep onset and wake-up time, researchers will be able to obtain data on periods of wakefulness and time spent in key sleep stages, including light, deep, and rapid eye movement (REM) sleep.
T3-2 month later
Physiological Monitoring Tools
Time Frame: T4-3 month later
Garmin Vivosmart 5. This wearable device will track heart rate, exercise frequency, exercise duration, exercise intensity, step count, and sleep data. Data will be integrated with the Garmin Connect app for real-time monitoring and feedback. A preliminary study conducted by our research team in 2020 showed a high correlation (r = 0.91) between heart rate measurements obtained from the Garmin Vivosmart and the Zephyr BioHarness, supporting its use for home-based heart rate monitoring. Participants will wear the device at home to facilitate real-time tracking of exercise intensity and physiological responses during the intervention. Advanced sleep tracking in compatible Garmin devices incorporates multiple factors to provide information on sleep patterns. In addition to basic information, such as sleep onset and wake-up time, researchers will be able to obtain data on periods of wakefulness and time spent in key sleep stages, including light, deep, and rapid eye movement (REM) sleep.
T4-3 month later
Physiological Monitoring Tools
Time Frame: T5- 6 month later
Garmin Vivosmart 5. This wearable device will track heart rate, exercise frequency, exercise duration, exercise intensity, step count, and sleep data. Data will be integrated with the Garmin Connect app for real-time monitoring and feedback. A preliminary study conducted by our research team in 2020 showed a high correlation (r = 0.91) between heart rate measurements obtained from the Garmin Vivosmart and the Zephyr BioHarness, supporting its use for home-based heart rate monitoring. Participants will wear the device at home to facilitate real-time tracking of exercise intensity and physiological responses during the intervention. Advanced sleep tracking in compatible Garmin devices incorporates multiple factors to provide information on sleep patterns. In addition to basic information, such as sleep onset and wake-up time, researchers will be able to obtain data on periods of wakefulness and time spent in key sleep stages, including light, deep, and rapid eye movement (REM) sleep.
T5- 6 month later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Defense Medical Center, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AI feedback digital exercise

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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