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 adherence, sleep quality, depressive symptoms, and quality of life with 90 participants in a 3-arm randomized trial.

Conditions

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

Interventions

BEHAVIORAL

AI-PEF

Participants 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.

BEHAVIORAL

Theory-based digital exercise

The theory-based digital exercise group will follow the same in-person clinic visits and walking program as AI-PEF but without AI-driven feedback

BEHAVIORAL

Active Control

Participants 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.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2030-12-31

Completion

2031-08-31