Effects of an AI-driven Personalized Exercise Feedback Program on Exercise Adherence and Health Outcomes in Patients With Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
- 主要终点
- Adherence
研究概览
简要总结
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.
详细描述
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
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Physicians are masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active control group
the Active control group, receiving general exercise recommendations as part of standard care in a 1:1:1 ratio.
干预措施: Active Control (Behavioral)
AI-PEF
the AI-PEF group, receiving a machine learning-powered personalized exercise program.
干预措施: AI-PEF (Behavioral)
Theory-based digital exercise
Theory-based digital exercise group, engaging in structured digital exercise without machine learning- powered feedback.
干预措施: Theory-based digital exercise (Behavioral)
结局指标
主要结局
Adherence
时间窗: 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.
Adherence
时间窗: 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.
Adherence
时间窗: 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.
Adherence
时间窗: 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.
Adherence
时间窗: 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.
The Chinese Version of the Sport Motivation Scale-II
时间窗: 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.
The Chinese Version of the Sport Motivation Scale-II
时间窗: 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.
The Chinese Version of the Sport Motivation Scale-II
时间窗: 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.
The Chinese Version of the Sport Motivation Scale-II
时间窗: 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.
The Chinese Version of the Sport Motivation Scale-II
时间窗: 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.
The mHealth App usability questionnaire
时间窗: 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.
The mHealth App usability questionnaire
时间窗: 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.
The mHealth App usability questionnaire
时间窗: 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.
The mHealth App usability questionnaire
时间窗: 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.
The mHealth App usability questionnaire
时间窗: 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.
6-Minute Walk Test
时间窗: 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.
6-Minute Walk Test
时间窗: 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.
6-Minute Walk Test
时间窗: 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.
6-Minute Walk Test
时间窗: 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.
6-Minute Walk Test
时间窗: 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.
次要结局
- Physiological Monitoring Tools(T5- 6 month later)
- Physiological Monitoring Tools(T2- 1 month later)
- Physiological Monitoring Tools(T3-2 month later)
- Physiological Monitoring Tools(T4-3 month later)
- The Rivermead Post-Concussion Symptoms Questionnaire(T1- baseline)
- The Rivermead Post-Concussion Symptoms Questionnaire(T2- 1 month later)
- The Rivermead Post-Concussion Symptoms Questionnaire(T3- 2 month later)
- The Rivermead Post-Concussion Symptoms Questionnaire(T4- 3 month later)
- The Rivermead Post-Concussion Symptoms Questionnaire(T5- 6 month)
- The Beck Depression Inventory-II(T1- baseline)
- The Beck Depression Inventory-II(T2-1 month later)
- The Beck Depression Inventory-II(T3- 2 month later)
- Physiological Monitoring Tools(T1- baseline)
- The Beck Depression Inventory-II(T5- 6 month later)
- The Pittsburgh Sleep Quality Index(T5-6 month later)
- Semi-Structured Interviews(T5- 6 month later)
- The Godin-Shephard Leisure Time Physical Activity Questionnaire(T5-6 month later)
- The World Health Organization Quality of Life Scale-brief(T5- 6 month later)
- Mini-Mental State Examination(T5- 6 month later)
- Montreal Cognitive Assessment(T5-6 month later)
- Near-Infrared Brain Blood Flow Imaging(T5- 6 month later)
- cardiac metabolic performance benchmark(T5- 6 month later)
- The Pittsburgh Sleep Quality Index(T1-baseline)
- The Godin-Shephard Leisure Time Physical Activity Questionnaire(T1 -baseline)
- The World Health Organization Quality of Life Scale-brief(T1 - baseline)
- Mini-Mental State Examination(T1- baseline)
- The Beck Depression Inventory-II(T4-3 month later)
- Montreal Cognitive Assessment(T1-baseline)
- Near-Infrared Brain Blood Flow Imaging(T1 - baseline)
- cardiac metabolic performance benchmark(T1- baseline)
- Semi-Structured Interviews(T1- baseline)
- The Pittsburgh Sleep Quality Index(T2- 1 month later)
- The Pittsburgh Sleep Quality Index(T3-2 month later)
- The Pittsburgh Sleep Quality Index(T4-3 month later)
- The Godin-Shephard Leisure Time Physical Activity Questionnaire(T2 -1 month later)
- The Godin-Shephard Leisure Time Physical Activity Questionnaire(T3 -2 month later)
- The Godin-Shephard Leisure Time Physical Activity Questionnaire(T4-3 month later)
- The World Health Organization Quality of Life Scale-brief(T2 - 1 month later)
- The World Health Organization Quality of Life Scale-brief(T3 - 2 month later)
- The World Health Organization Quality of Life Scale-brief(T4 - 3 month later)
- Mini-Mental State Examination(T2-1 month later)
- Mini-Mental State Examination(T3-2 month later)
- Mini-Mental State Examination(T4-3 month later)
- Montreal Cognitive Assessment(T2-1 month later)
- Montreal Cognitive Assessment(T3-2 month later)
- Montreal Cognitive Assessment(T4-3 month later)
- Near-Infrared Brain Blood Flow Imaging(T2- 1 month later)
- Near-Infrared Brain Blood Flow Imaging(T3-2 month later)
- Near-Infrared Brain Blood Flow Imaging(T4- 3 month later)
- cardiac metabolic performance benchmark(T2- 1 month later)
- cardiac metabolic performance benchmark(T3-2 month later)
- cardiac metabolic performance benchmark(T4- 3 month later)
- Semi-Structured Interviews(T2- 1 month later)
- Semi-Structured Interviews(T3- 2 month later)
- Semi-Structured Interviews(T4-3 month later)
研究者
Hui-Hsun Chiang
Professor
National Defense Medical Center, Taiwan