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 adherence, sleep quality, depressive symptoms, and quality of life with 90 participants in a 3-arm randomized trial.
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
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.
Parallel
AI-PEF
BehavioralParticipants will follow a 12-week walking program with five 30-minute sessions per week, progressively increasing intensity based on heart rate and effort indices. Garmin fitness trackers will monitor adherence and intensity. Remote guidance will support participants via weekly digital health messages on the LINE app, offering personalized feedback, goal reinforcement, and lifestyle recommendations. Participants will also receiThese AI feedback implementations will be tailored to complement the in-person education and will include reminders of the individualized goals set during the remote exercise intervention and consultation . The digital component will also offer a platform for patients to share their progress and seek further guidance during the scheduled in-person consultation. The use of digital AI feedback aligns with the trend of integrating technology into healthcare services, providing a convenient and accessible modality for supporting parents engaging in regular exercise.
Theory-based digital exercise
BehavioralThe theory-based digital exercise group will follow the same in-person clinic visits and walking program as AI-PEF but without AI-driven feedback
Active Control
BehavioralParticipants in the active control group will receive standard TBI care, including Garmin-based self-monitoring and routine clinic visits at baseline (T0), 3 months (T1), and 6 months (T2). These visits will include general health education and recommendations on daily physical activity. No personalized or digital exercise strategies will be provided. Participants completing the 6-month protocol will have the option to access the AI-PEF program after the study.
Adherence
Exercise adherence will be the primary outcome, defined as the percentage of participants completing at least five exercise sessions weekly over 12 weeks. Adherence will be objectively tracked using the Garmin Vivosmart 5, which monitors exercise duration and frequency. Range of adherence are 0- 100%, the higher percentage means the higher adherence.
Adherence
Exercise adherence will be the primary outcome, defined as the percentage of participants completing at least five exercise sessions weekly over 12 weeks. Adherence will be objectively tracked using the Garmin Vivosmart 5, which monitors exercise duration and frequency. Range of adherence are 0- 100%, the higher percentage means the higher adherence.
Adherence
Exercise adherence will be the primary outcome, defined as the percentage of participants completing at least five exercise sessions weekly over 12 weeks. Adherence will be objectively tracked using the Garmin Vivosmart 5, which monitors exercise duration and frequency. Range of adherence are 0- 100%, the higher percentage means the higher adherence.
Adherence
Exercise adherence will be the primary outcome, defined as the percentage of participants completing at least five exercise sessions weekly over 12 weeks. Adherence will be objectively tracked using the Garmin Vivosmart 5, which monitors exercise duration and frequency. Range of adherence are 0- 100%, the higher percentage means the higher adherence.
The Revised Sport Motivation Scale-II
The Revised Sport Motivation Scale-II (SMS-II), validated in Chinese, will measure six types of motivation, including amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic motivation. A total of 18 items with Likert scale 1-7, 5 domains: Intrinsic Regulation: 3, 9, 17, Integrated Regulation: 4, 11, 14, Identified Regulation: 6, 12, 18, Introjected Regulation: 1, 7, 16, External Regulation: 5, 8, 15, Non Regulation: 2, 10, 13. Each domain is record separately. The higher scores means the higher tendency of the domain. The range of the minimum and maximum values are 18-126.
The Revised Sport Motivation Scale-II
The Revised Sport Motivation Scale-II (SMS-II), validated in Chinese, will measure six types of motivation, including amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic motivation. A total of 18 items with Likert scale 1-7, 5 domains: Intrinsic Regulation: 3, 9, 17, Integrated Regulation: 4, 11, 14, Identified Regulation: 6, 12, 18, Introjected Regulation: 1, 7, 16, External Regulation: 5, 8, 15, Non Regulation: 2, 10, 13. Each domain is record separately. The higher scores means the higher tendency of the domain. The range of the minimum and maximum values are 18-126.
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms.
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
