Association of neuromuscular functions with fatigue in people with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Predicted variable:
研究概览
简要总结
Background:
Fatigue is a prevalent and debilitating symptom in individuals with type 2 diabetes mellitus (T2DM), often impacting physical activity, psychological well-being, and overall quality of life. Neuromuscular function and other factors such as depression and functional capacity may play significant roles in its manifestation.
Aims:
-
To study the association of neuromuscular function with fatigue in individuals with T2DM.
-
To investigate the relationship between physical activity, depression, quality of life, and fatigue in this population.
-
To classify individuals into different fatigue levels and analyze their functional capacity.
Methodology
It is a observational cross sectional study.
Predicted variable:
Fatigue: Multidimensional Fatigue Inventory will assess fatigue
Predictor variables:
1.Muscle strength: Handheld dynamometer reading of knee extensors, ankle dorsiflexors and handgrip to assess muscle strength.
Leg press testing: For 1 Repetition Maximum determination
-
Muscle endurance: 2 minutes step test to assess muscle endurance
-
Nerve function: Nerve conduction velocity of Deep peroneal (Motor) and Sural nerve (sensory)
-
Sensory function: Monofilament test and Vibration Perception Threshold
-
Physical activity: International Physical Activity Questionnaire- Short form to assess Physical activity
-
Depression: Hamilton Depression Rating Scale to assess depression.
-
Quality of life : will be assessed using SF12-V2 questionnaire.
-
Functional status: International Classification of Functioning Disability and Health to assess the function status.
Results: will be reported for all variables at baseline.
Significance: This study aims to identify key factors influencing fatigue in T2DM and provide a foundation for tailored intervention strategies to enhance patient outcomes and quality of life
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults diagnosed with Type 2 Diabetes Mellitus more than or equal to 6 months Male and female Age between 40-70 years.
排除标准
- •Diabetic foot ulcer Lower limb amputation wheelchair bound Over 70 years Known history of stroke, cancer or other central nervous system pathology which may cause additional burden of fatigue besides diabetes Inability to ambulate.
结局指标
主要结局
Predicted variable:
时间窗: Baseline assessment will be taken
Fatigue: will be assessed Multidimensional Fatigue Inventory
时间窗: Baseline assessment will be taken
Predictor variables:
时间窗: Baseline assessment will be taken
1. Muscle strength: Handheld dynamometer reading of knee extensors, ankle dorsiflexors.
时间窗: Baseline assessment will be taken
Leg press test: to assess 1 Repetition Maximum determination
时间窗: Baseline assessment will be taken
2. Muscle endurance: 2 minutes step test to assess muscle endurance
时间窗: Baseline assessment will be taken
3. Nerve function: Nerve conduction velocity of Deep peroneal (Motor) and Sural nerve (sensory)
时间窗: Baseline assessment will be taken
4. Sensory function: Monofilament test and Vibration Perception Threshold
时间窗: Baseline assessment will be taken
5. Physical activity: International Physical Activity Questionnaire- Short form to assess Physical activity
时间窗: Baseline assessment will be taken
6. Depression: Hamilton Depression Rating Scale to assess depression.
时间窗: Baseline assessment will be taken
7. Quality of life : will be assessed using SF12-V2 questionnaire.
时间窗: Baseline assessment will be taken
8. Functional status: International Classification of Functioning Disability and Health to assess the function status.
时间窗: Baseline assessment will be taken
次要结局
未报告次要终点
研究者
Dr Majumi M Noohu
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi