Body Composition Assessment in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- To compare different methods of body composition analyses with the gold standard 4-compartment monitoring to determine accuracy and validity of those alternative, but less labor-intensive techniques.
研究概览
简要总结
The purpose of this research is to evaluate different methods of measuring body composition (amount of fat, muscle, bone, and water in your body) and to determine relationships between body composition and other medical problems associated with spinal cord injury (SCI).
详细描述
A preliminary investigation in our laboratory has demonstrated the advantage of using 4-compartment modeling to assess body composition in SCI adults. In comparing body composition analyses techniques in 20 individuals with SCI, we found Total Error to be 8.0% with Dual X-ray Absorptiometry, 8.4% with hydrodensitometry, 11.5% with bioelectrical impedance analysis, and 21.8% with standard skinfold equations when compared to 4-compartment modeling, the currently accepted gold standard for body composition assessment. To date there is no gold standard for the determination of body composition in SCI individuals.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria for participation will include men and women within the age range of 18-65 years old with C5-L2 Motor-Complete (ASIA A&B)
- •SCI of duration greater than 12 months to ensure a homogenous sample.
排除标准
- •Persons with uncompensated hypothyroidism, and/or renal disease will be excluded from the study.
- •Additionally, individuals with uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis
- •Pressure ulcers > Grade II will be excluded.
结局指标
主要结局
To compare different methods of body composition analyses with the gold standard 4-compartment monitoring to determine accuracy and validity of those alternative, but less labor-intensive techniques.
时间窗: 3 years
次要结局
- To assess the relationship between % body fat, visceral fat, and markers of the metabolic syndrome, including Plasminogen Activator Inhibitor-1 (PAI-1), Thrombin-Activatable Fibrinolysis Inhibitor (TAFI), and high-sensitivity C-Reactive Protein (hsCRP)(3 years)
- To develop body composition regression equations that can be easily utilized in a clinical setting to estimate risk for the metabolic syndrome in persons with SCI.(3 years)
- To cross-validate the derived regression equations against the gold standard 4-compartment model in an independent group of persons with SCI.(3 years)