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
- 1
- 主要终点
- Change in Insulin Sensitivity (Si)
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
- •Adults 18-65 years of age (inclusive)
- •Sex: male or female
- •Women of child-bearing potential who agree to refrain from getting pregnant during the trial
- •C4-T4 motor complete (AIS A&B) spinal cord injury for duration greater than 12 months
- •<5% change in body weight over the past 12 months
排除标准
- •<22% body fat
- •Unresponsive to neurostimulation
- •Those who have participated in an FES or ACE exercise program (>60 minutes/week) within the past 3 months
- •Known orthopaedic limitations
- •Coronary artery disease
- •Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus (fasting glucose>126 or HgbA1c>7.0)
- •Uncompensated Hypothyroidism (Stable on medication >1 year or not on medication)
- •Renal disease
- •Uncontrolled autonomic dysreflexia, recent (within 3 months)
- •Deep vein thrombosis
- •Pressure ulcers > Grade II
- •Decisional impairment
- •Any potential causes of autonomic dysreflexia at the discretion of the PI
- •Prisoners
- •Pregnant or nursing women
研究组 & 干预措施
Home-Based Exercise & Diet Group
16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention
干预措施: Functional Electrical Stimulation Leg Cycle Ergometry (Device)
Home-Based Exercise & Diet Group
16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention
干预措施: Diet (Behavioral)
Home-Based Diet Alone Group
Diet intervention
干预措施: Diet (Behavioral)
结局指标
主要结局
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
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 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
Change in Insulin Sensitivity (Si)
时间窗: Baseline, 21 weeks
Insulin Sensitivity will be measured using intravenous glucose tolerance test (IVGTT)
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.
次要结局
- C-Reactive Protein (hsCRP)(Baseline, 21 weeks)
- High Density Lipoprotein Cholesterol (HDL-C)(Baseline, 21 weeks)
- Change in Total Cholesterol : HDL-C Ratio(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