To Study the Effect of Multimodal Exercise on Body Composition, Physiological, and Biochemical Parameters among Diabetic subjects having Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Muscle Mass
研究概览
简要总结
Introduction
Sarcopenia is a significant public health concern, characterized by progressive loss of skeletal muscle mass, strength and function. It is one of the important functions for contributing to frailty, physical disability and increased risk of falls. Sarcopenia negatively impacts quality of life and poses substantial healthcare challenges. Its multifactorial etiology includes ageing, physical inactivity, chronic diseases, and nutritional deficiencies, making targeted interventions essential for prevention and management. With ageing, the amount of muscle cells is gradually depleted, and anabolic stimuli create resistance with a consequent decrease in mitochondrial function, changes in gene expression, reduced insulin sensitivity, and impaired neuromuscular signalling.
Diabetes has been associated with impaired insulin sensitivity and persistent systemic inflammation, which can increase the risk of sarcopenia. Globally, the prevalence of sarcopenia varies from 10% to 40%, contingent on evaluation standards and population variables. But according to recent meta-analyses, the prevalence of sarcopenia in diabetic patients is two to three times higher than in non-diabetic people. In India, the prevalence of sarcopenia, severe sarcopenia, and probable sarcopenia was 6.1%, 18.8%, and 43%, respectively. Exercise has emerged as a key component in the treatment of sarcopenia, with evidence supporting its function in increasing muscle mass, strength, and physical performance. While other modalities, such aerobic exercises and multimodal training regimens, have shown complimentary advantages, resistance training in particular has been thoroughly researched for its anabolic effects. Exercise is available to all, but nutrition is not feasible for most people. Nutrition alone cannot overcome the loss of muscle mass and it is not feasible for all. The expanding field of research has yielded diverse findings due to variations in study methodologies, participant demographics, intervention strategies, and outcome assessments. This inconsistency has made it challenging to establish clear-cut recommendations. While previous investigations have shown that consistent physical activity can enhance muscular performance and metabolic health across various groups, including those with chronic conditions, there remains a gap in our understanding. Specifically, we lack comprehensive knowledge about how structured exercise programs impact the physical and biochemical profiles of individuals with both sarcopenia and diabetes.
Objective
· Evaluate the effect of multimodal exercise on Body composition, Physiological, and Biochemical parameters among Sarcopenia Patients with Type 2 Diabetes.
Rationale
· Sarcopenia, characterized by progressive loss of skeletal muscle mass and function, is increasingly recognized as a critical comorbidity in individuals with type 2 diabetes mellitus (T2DM), even among younger adults. The coexistence of these conditions amplifies the risk of physical disability, metabolic complications, and reduced quality of life, emphasizing the urgent need for effective, evidence-based interventions tailored to this population. While the prevalence and impact of sarcopenia have been extensively studied in older adults, there is a significant gap in research focusing on younger adults (20–50 years), despite evidence that early-onset sarcopenia in T2DM may accelerate disease progression and functional decline.
· Multimodal exercise interventions-which combine resistance, aerobic, and balance training-have emerged as the most promising non-pharmacological strategies for improving muscle strength, physical function, and metabolic health in sarcopenic patients with T2DM. Meta-analyses and randomized controlled trials in older populations consistently demonstrate that such interventions lead to significant improvements in muscle strength (e.g., handgrip, leg strength), physical performance (e.g., sit-to-stand, timed up and go tests), and glycemic control (e.g., reductions in HbA1c).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Inclusion Criteria: 1-Adults aged 18-60 years diagnosed with Type 2 Diabetes Mellitus (T2DM) 2-Able to walk independently or with minimal assistance 3-No history of neurological disorders affecting cognition (e.g., stroke, Alzheimer’s) 4-Willing to provide informed consent.
排除标准
- •Individuals with severe mobility impairments preventing participation.
- •Diagnosed neurodegenerative diseases (e.g., dementia, Parkinson’s).
- •Uncontrolled psychiatric conditions.
- •Use of medications affecting muscle function or cognition.
结局指标
主要结局
Muscle Mass
时间窗: At baseline and at 12 Weeks
Body Mass Index (BMI)
时间窗: At baseline and at 12 Weeks
Waist-to-Hip Circumference Ratio
时间窗: At baseline and at 12 Weeks
Physiological Parameters
时间窗: At baseline and at 12 Weeks
Muscle Strength
时间窗: At baseline and at 12 Weeks
Physical Performance
时间窗: At baseline and at 12 Weeks
Balance
时间窗: At baseline and at 12 Weeks
Heart Rate & Blood Pressure
时间窗: At baseline and at 12 Weeks
Quality of Life
时间窗: At baseline and at 12 Weeks
Sleep Quality
时间窗: At baseline and at 12 Weeks
Biochemical Parameters
时间窗: At baseline and at 12 Weeks
Glycemic Control (Hba1c)
时间窗: At baseline and at 12 Weeks
Blood Glucose Levels
时间窗: At baseline and at 12 Weeks
Lipid Profile
时间窗: At baseline and at 12 Weeks
次要结局
- Inflammatory Markers(Smoking Status)
