AI-Driven Multimodal Rehabilitation Framework for Type 2 Diabetes Integrating Digital Health Technologies, Intermittent Fasting, and Resistance Training to Optimize Metabolic and Functional Outcomes
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Superior University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- HbA1c (Biochemical Outcome)
Overview
Brief Summary
This randomized controlled trial aims to evaluate the effectiveness of an AI-driven multimodal rehabilitation framework combining digital health technologies, intermittent fasting, and resistance training in individuals with Type 2 Diabetes Mellitus (T2DM). The study will integrate mobile-based AI monitoring for glucose trends, physical activity tracking, and dietary adherence reminders, thereby improving patient engagement and self-management.
Detailed Description
Participants will be randomized into two groups: the intervention group receiving AI-guided resistance training alongside intermittent fasting, and the control group receiving standard diabetes care. Outcomes will include changes in HbA1c, insulin sensitivity (HOMA-IR), muscle strength, functional mobility, and quality of life. The study will also assess adherence, feasibility, and cost-effectiveness. By utilizing AI-enabled technology and lifestyle-based interventions, this study addresses the gap between clinical management and sustainable self-care in T2DM. The framework is designed to be low-cost, scalable, and adaptable, making it suitable for resource-limited healthcare systems.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with Type 2 Diabetes (≥1 year)
- •HbA1c between 6.5% and 9.0%
- •Sedentary or low physical activity levels
- •BMI: 25-35 kg/m²
- •Able to perform mild-to-moderate exercise
Exclusion Criteria
- •any other disability
- •not willing
Arms & Interventions
AI-Guided Multimodal Rehabilitation Program
Intervention: AI-Guided Multimodal Rehabilitation Program (Combination Product)
Standard Diabetes Care
Intervention: Standard Diabetes Care (Diagnostic Test)
Outcomes
Primary Outcomes
HbA1c (Biochemical Outcome)
Time Frame: 24 Months
HbA1c will be assessed from venous blood and reported as a percentage (%).
HOMA-IR (Biochemical Outcome)
Time Frame: 24 Months
HOMA-IR will be derived from fasting glucose and fasting insulin measurements and presented as a unitless index.
6-Minute Walk Test (Functional capacity; distance in meters)
Time Frame: 24 Months
The 6-Minute Walk Test (6MWT) measures functional capacity by recording the total distance (in meters) a person can walk in six minutes on a flat, straight course. Healthy adults typically walk between 400 and 700 meters,
WHOQOL-BREF
Time Frame: 24 Months
The WHOQOL-BREF is a 26-item, self-report questionnaire developed by the World Health Organization (WHO) for measuring an individual's self-perceived quality of life. It is a widely used and cross-culturally validated abbreviated version of the original, more comprehensive WHOQOL-Score 0-100
Diabetes Self-Management Questionnaire
Time Frame: 24 Months
Diabetes Self-Management Questionnaire (DSMQ), first reverse the scores for any negatively worded items so higher scores consistently indicate more effective self-care. Then, sum the scores for all items to get a raw total score. This raw score can be transformed to a scale of 0-10 by dividing the raw score by the theoretical maximum and multiplying by 10 for easier interpretation and comparison.
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad Naveed Babur
Principal Investigator
Superior University