Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury (TEAM-SCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in percent of lean body mass
研究概览
简要总结
The purpose of this research is to test the health benefits of using functional electrical stimulation for lower extremity exercise at home.
详细描述
The specific objectives are to assess the impact of 16 weeks of home-based telemonitored functional electrical stimulation leg cycle ergometry (FESLCE) exercise on body composition and metabolic health in adults with C4-T4 motor complete SCI. This study is available only to those who were previously enrolled in the SCIENCE protocol #20190659 that were randomized to the diet alone group. After completing the dietary intervention, those individuals will have an opportunity to experience FES bicycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Women of child-bearing potential who agree to refrain from getting pregnant during the trial
- •Previously enrolled in the SCIENCE protocol (NCT03495986) randomized to the diet alone group in SCIENCE, and are willing to complete an 8-week (2 month) washout period after the completion of the dietary intervention in the study.
排除标准
- •Do not meet inclusion criteria above
- •Those who have participated in a Functional Electrical Stimulation (FES) or ACE exercise program (>60 minutes/week) within the past 3 months
- •Self-reported or documented history of:
- •orthopedic limitations
- •coronary artery disease
- •type 1 diabetes mellitus; insulin-requiring Type 2 diabetes mellitus; untreated Type 2 diabetes mellitus
- •untreated hypothyroidism
- •renal disease
- •uncontrolled autonomic dysreflexia, recent (within 3 months)
- •deep vein thrombosis (within the past 3 months)
- •On anticoagulation therapy
- •Pressure injuries > Grade II
- •Decisional impairment
- •Prisoners
- •Pregnant or nursing women
- •Any potential causes of autonomic dysreflexia at the discretion of the PI
结局指标
主要结局
Change in percent of lean body mass
时间窗: Baseline, 20 weeks (Post Intervention)
Percent lean body mass will be assessed using DXA
Change in percent body fat
时间窗: Baseline, 20 weeks (Post Intervention)
Percent body fat will be assessed using Dual Energy x-ray absorbency (DXA)
Change in percent visceral fat
时间窗: Baseline, 20 weeks (Post Intervention)
Percent visceral fat will be assessed using DXA
Change in percent of fat free mass
时间窗: Baseline, 20 weeks (Post Intervention)
Percent fat free mass will be assessed using DXA
次要结局
- Change in Lipid Panel values(Baseline, 20 weeks (Post Intervention))
- Change in glucose levels(Baseline, 20 weeks (Post Intervention))
- Change in Insulin levels(Baseline, 20 weeks (Post Intervention))
- Change in hsCRP levels(Baseline, 20 weeks (Post Intervention))
- Change in HgbA1C levels(Baseline, 20 weeks (Post Intervention))
- Change in resting metabolic rate(Baseline, 20 weeks (Post Intervention))
研究者
Eduard Tiozzo, PhD
Research Associate Professor
University of Miami