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

Sponsor
National Defense Medical Center, Taiwan
Study ID
NCT06817564
Status
Not Yet Recruiting

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Conditions

  • AI (Artificial Intelligence)
  • Digital Health
  • Exercise
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AI-PEF — BEHAVIORAL
    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.
  • Theory-based digital exercise — BEHAVIORAL
    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 Control — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Feb 10, 2025
Start date
Aug 17, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2030
Completion
Aug 31, 2031

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: AI-PEF
    the AI-PEF group, receiving a machine learning-powered personalized exercise program.
  • Experimental: Theory-based digital exercise
    Theory-based digital exercise group, engaging in structured digital exercise without machine learning- powered 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.

Primary Outcome Measure

Adherence [ Time Frame: T1-baseline ]

Central Contacts

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