AI-Driven Multimodal Rehabilitation Framework for Type 2 Diabetes Integrating Digital Health Technologies, Intermittent Fasting, and Resistance Training to Optimize Metabolic and Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- HbA1c (Biochemical Outcome)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •any other disability
- •not willing
研究组 & 干预措施
Standard Diabetes Care
干预措施: Standard Diabetes Care (Diagnostic Test)
AI-Guided Multimodal Rehabilitation Program
干预措施: AI-Guided Multimodal Rehabilitation Program (Combination Product)
结局指标
主要结局
HbA1c (Biochemical Outcome)
时间窗: 24 Months
HbA1c will be assessed from venous blood and reported as a percentage (%).
HOMA-IR (Biochemical Outcome)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University