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

Summary

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.

Conditions

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

Interventions

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.

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.

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.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-17

Primary Completion

2030-12-31

Completion

2031-08-31