AI-driven Personalized Exercise Feedback Program on Exercise Adherence in Traumatic Brain Injury
NCT ID: NCT06817564
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
125 participants
INTERVENTIONAL
2025-03-01
2031-08-31
Brief Summary
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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.
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Detailed Description
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Study procedures
1. Phase I (Year 1): Development and Pilot Testing (Aim 1) Phase I will focus on developing and refining the AI-PEF through expert validation and pilot testing. This phase will use a sequential-parallel hybrid design to develop and evaluate the appropriateness of the AI-PEF to deliver personalized exercise empowerment. Stage 1, Delphi Process for AI-PEF Development: Ten experts from diverse fields will participate in two Delphi rounds to finalize the AI-PEF framework. This includes refining algorithms, educational materials, and preliminary validation of key components, such as personalization algorithms and behavior-change strategies. Stage 2, Small-Scale Pilot Study (Early Feedback): A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity.
2. Phase II : Larger Pilot Study (Aim 2) Phase II will focus on evaluating the feasibility, acceptability, and preliminary effectiveness of the refined AI-PEF intervention. A two-parallel-group design will be employed, with 30 participants, 15 participants per group, randomly assigned in a 1:1 ratio to the AI-PEF group and Active control group. Over three months, AI-PEF participants will engage in personalized exercise guided by AI, while active control participants will follow standard exercise recommendations. Both qualitative and quantitative data will be collected. Assessments will occur at baseline (T0) and 3 months (T1), including fitness tracker data, questionnaires (motivation, sleep, symptoms), and semi-structured interviews. The primary outcome of interest will be adherence rates, while secondary outcomes will focus on motivation and various health metrics.
3. Phase III : Full- scale three-arm RCT (Aim 3) Phase III will assess the long-term impact of the AI- PEF on exercise adherence, motivation, and health outcomes through a 3-arm RCT randomly assigned to one of three groups: (1) the AI-PEF group, receiving a machine learning-powered personalized exercise program; (2) the Theory-based digital exercise group, engaging in structured digital exercise without machine learning- powered feedback; or (3) the Active control group, receiving general exercise recommendations as part of standard care in a 1:1:1 ratio. Over six months, participants will receive group-specific interventions, with assessments conducted at baseline (T0), 3 months (T1), and 6 months (T2). Primary outcomes, including exercise adherence, will be objectively measured via Garmin fitness trackers, while secondary outcomes, such as motivation, sleep quality, and symptom reduction, will be assessed through standardized questionnaires and qualitative interviews. These standardized questionnaires are being used in our current digital remote exercise trial in patients with mild TBI (NSTC 112-2314-B-016-007-MY2) and have performed well on physiological performance. Data will be collected and analyzed using both quantitative and qualitative methods to compare adherence, motivation, and health outcomes across the three groups, identifying the efficacy of AI-PEF relative to standard interventions. Procedures will adhere to the blinding and randomization protocols described in Intervention Fidelity, ensuring unbiased assignment and data collection processes. This proposed study protocol is closely aligned with those that have been successfully implemented in our previous digital exercise trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Phase 3: Examine the impact of the AI-PEF on exercise adherence and health outcomes
SUPPORTIVE_CARE
TRIPLE
Study Groups
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AI-PEF
the AI-PEF group, receiving a machine learning-powered personalized exercise program.
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.
Theory-based digital exercise
Theory-based digital exercise group, engaging in structured digital exercise without machine learning- powered feedback.
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
Active control group
the Active control group, receiving general exercise recommendations as part of standard care in a 1:1:1 ratio.
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.
Interventions
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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.
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Defense Medical Center, Taiwan
OTHER
Responsible Party
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Hui-Hsun Chiang
Professor
Central Contacts
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Other Identifiers
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AI feedback digital exercise
Identifier Type: -
Identifier Source: org_study_id
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