Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Fat Free Mass
研究概览
简要总结
Evaluate and compare the health benefits of an at home exercise program using functional electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group in adults with spinal cord injury.
详细描述
The purpose of this proposal is to evaluate and compare the health benefits of home-based functional electrical stimulation leg cycle ergometry plus diet (HBFESLCE + Diet) to home-based (HB) Diet alone. This is a randomized, baseline-controlled, prospective, interventional trial to assess the impact of a 16-week exercise and/or diet intervention on selected fitness parameters in adults with high SCI. Primary outcome measures will include body composition by iDXA, insulin sensitivity, glucose effectiveness and BMR, while secondary outcomes will include lower extremity BMC and density, lipid profiles, and hsCRP determined before and after the 16-week interventions. Subjects will be randomly assigned to either HBFES LCE + Diet on an RT300 ergometer or Home-based (HB) Diet Alone intervention. Both groups will be routinely monitored via telemedicine while at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Fat Free Mass
时间窗: Baseline, 21 weeks
Body composition will be assessed using Dual-Energy X-ray Absorptiometry (DXA), which provides precise measurements of both absolute fat mass (FM) and absolute fat-free mass (FFM) in kilograms. FFM represents a distinct component of total body mass and will be used to evaluate lean tissue (i.e.,FFM) over time.
Change in Insulin Sensitivity (Si)
时间窗: Baseline, 21 weeks
Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
Change in Glucose Effectiveness (Sg)
时间窗: Baseline, 21 weeks
Glucose Effectiveness will be measured using IVGTT
Change in Basal Metabolic Rate (BMR)
时间窗: Baseline, 21 weeks
BMR will be measured by indirect calorimetry
Percent Body Fat Assessed by DXA at Baseline and 21 Weeks
时间窗: Baseline, 21 weeks
Percent body fat will be assessed in percentage using Dual Energy x-ray absorbency (DXA). Assessments will be conducted at baseline and at 21 weeks to evaluate changes in body composition over time.
Change in Insulin Sensitivity (Si)
时间窗: Baseline, 21 weeks
Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
Change in Basal Metabolic Rate (BMR)
时间窗: Baseline, 21 weeks
BMR will be measured by indirect calorimetry
次要结局
- High Density Lipoprotein Cholesterol (HDL-C)(Baseline, 21 weeks)
- Change in Total Cholesterol : HDL-C Ratio(Baseline, 21 weeks)
- C-Reactive Protein (hsCRP)(Baseline, 21 weeks)
- Lower Extremity Bone Mineral Density (BMD) - Femur(Baseline, 21 weeks)
研究者
Eduard Tiozzo, PhD
Research Assistant Professor
University of Miami