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

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.

NCT Number	NCT06817564
Lead Sponsor	National Defense Medical Center, Taiwan
Conditions	Traumatic Brain Injury, Exercise, AI (Artificial Intelligence), Digital Health
Enrollment	125 participants
Start Date	2025-03-01
Primary Completion	2030-12-31 (estimated)
Study Completion	2031-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-12