Exercise to Reduce Obesity in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in Insulin Sensitivity (Si)
研究概览
简要总结
The purpose of this proposal was to evaluate and compare the health benefits of using upper extremity exercise versus functional electrical stimulation for lower extremity exercise. It was our hypothesis that both Functional Electrical Stimulation Leg Cycle Ergometry (FES LCE) exercise and voluntary Arm Crank Ergometry (ACE) upper extremity exercise would increase whole body energy expenditure, thereby increasing muscle mass, insulin sensitivity, glucose effectiveness and improving lipid profiles in adults with paraplegia.
详细描述
Objective
Spinal cord injuries (SCI) predispose individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing them at greater risk for diabetes, coronary artery disease, and upper extremity overuse syndrome as body weight increases. The specific objectives for the current proposal were to compare the impact of FES (functional electrical stimulation) lower extremity exercise versus upper extremity arm crank ergometry on energy metabolism, body composition and fat deposition, insulin sensitivity, glucose effectiveness, lower extremity bone mineral density and lipid profiles, in adults with complete paraplegia. Research Plan: A randomized, baseline-controlled, prospective, 16-week interventional trial was employed to assess the impact of FES LCE versus volitional arm crank ergometry exercise on energy metabolism, body composition and fat deposition, insulin sensitivity, glucose effectiveness, lower extremity bone mineral density and lipid profiles in adults with complete paraplegia. Methods: Twenty-four 18-65 y.o. individuals with motor complete T4-L2 SCI were assigned to either FES lower extremity exercise or upper extremity arm crank ergometry to compare impact on energy expenditure, obesity, and insulin sensitivity. Both groups were provided similar nutritional assessments and intervention. Exercise training consisted of five, 40-minute sessions at 70% maximal heart rate (HRmax) each week for a total of 16 weeks. Resting metabolic rate, exercise energy expenditure, body composition by DXA, insulin sensitivity, glucose effectiveness, lipid profiles, and lower extremity bone mineral density (BMD) were determined before and after 16-week exercise interventions.
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
- •Criteria for participation included men and women within the age range of 18-65 years old with BMI>25 kg/m2 who have had T4-L2 Motor-Complete (ASIA A&B) SCI for duration of greater than 12 months to ensure a homogenous sample.
排除标准
- •persons who were unresponsive to surface neurostimulation
- •had participated in an FES or ACE exercise (> 60 minutes/week) program within the past 3 months
- •and those with known orthopedic limitations
- •diabetes mellitus (fasting glucose>126 or HgbA1c>7.0) or known family history
- •hypothyroidism
- •and/or renal disease were excluded from the study.
- •Additionally, individuals with uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis, or pressure ulcers > Grade II were excluded.
结局指标
主要结局
Change in Insulin Sensitivity (Si)
时间窗: Baseline, 16-weeks
Change in insulin sensitivity (min\^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
%Body Fat Between Groups
时间窗: 16 weeks
Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.
Change in % Body Fat
时间窗: baseline, 16 weeks
Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Change in Fat-Free Mass
时间窗: baseline, 16 weeks
Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Change in Glucose Effectiveness (Sg)
时间窗: Baseline, 16-weeks
Change in Glucose Effectiveness (min\^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Fat Mass Between Groups
时间窗: 16 weeks
Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.
Fat Free Mass Between Groups
时间窗: 16 weeks
Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.
Change in Fat Mass
时间窗: Baseline, 16 Weeks
Change in Fat Mass (Kg) after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Insulin Sensitivity (Si) Between Groups
时间窗: 16 weeks
Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.
Glucose Effectiveness (Sg) Between Groups
时间窗: 16 weeks
Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.
次要结局
- Change in Low Density Lipoprotein Cholesterol (LDL)(baseline, 16 weeks)
- Lower Limb Bone Mineral Density Between Groups(16 weeks)
- Low Density Lipoprotein Cholesterol (LDL) Between Groups(16 weeks)
- Total Cholesterol (TC) Between Groups(16 weeks)
- Change in Lower Limb Bone Mineral Density(baseline, 16 weeks)
- Change in Lower Limb Bone Mineral Content(baseline, 16 weeks)
- Change in High Density Lipoprotein Cholesterol (HDL)(baseline, 16 weeks)
- Change in Total Cholesterol (TC)(baseline, 16 weeks)
- Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL)(Baseline, 16 weeks)
- Lower Limb Bone Mineral Content Between Groups(16 weeks)
- Triglycerides Between Groups(16 weeks)
- Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups(16 weeks)
- High Density Lipoprotein Cholesterol (HDL) Between Groups(16 weeks)
- Change in Triglycerides(baseline, 16 weeks)