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

NCT06817564 | Not Yet Recruiting

• 1 other identifier: AI feedback digital exercise
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

AI-Driven Personalized Exercise Program

Outcome Measures

Primary Outcomes (5)

• 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.

  T1-baseline

• 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.

  T2- 1 month later

• 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.

  T3- 2 month later

• 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.

  T4- 3 month later

• 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.

  T5- 6 month later

Secondary Outcomes (70)

• The Revised Sport Motivation Scale-II

  T1- baseline

• The Revised Sport Motivation Scale-II

  T2- 1 month later

• The Rivermead Post-Concussion Symptoms Questionnaire

  T1 baseline

• The Beck Depression Inventory-II

  T1 baseline

• The Pittsburgh Sleep Quality Index

  T1-baseline

Study Arms (3)

AI-PEF

EXPERIMENTAL

the AI-PEF group, receiving a machine learning-powered personalized exercise program.

Behavioral: AI-PEF

Theory-based digital exercise

EXPERIMENTAL

Theory-based digital exercise group, engaging in structured digital exercise without machine learning- powered feedback.

Behavioral: Theory-based digital exercise

Active control group

ACTIVE COMPARATOR

the Active control group, receiving general exercise recommendations as part of standard care in a 1:1:1 ratio.

Behavioral: Active Control

Interventions

AI-PEF BEHAVIORAL

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.

AI-PEF

Theory-based digital exercise BEHAVIORAL

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

Theory-based digital exercise

Active Control BEHAVIORAL

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.

Active control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• complete self-administered questionnaires.

You may not qualify if:

• hindering physical activity in the 6-minute walk test,
• cognitive impairments (MMSE \< 24),
• frontal lobe injuries or penetrating injury causing significant psychological dysfunction.
• Patients regularly engaging in moderate-to-high-intensity aerobic exercise or participating in other studies will also be excluded to avoid bias.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic; Motor Activity

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavior

Central Study Contacts

Hui-Hsun Chiang, Professor

CONTACT

886-2-87923100; sheisvivian@gmail.com

Hui-Hsun Chiang, Professor

CONTACT

886-921060383; huihsunchiang@mail.ndmctsgh.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Physicians are masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Phase 2: Evaluate the feasibility, acceptability, and preliminary effectiveness of the AI-PEF in improving patient outcomes. Phase 3: Examine the impact of the AI-PEF on exercise adherence and health outcomes

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 10, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): August 31, 2031
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share