The Effect of an Adaptive Exercise Program on Chronic Inflammation in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Effect of Exercise on Inflammation (C-reactive Protein)
研究概览
简要总结
Long lasting inflammation in the body is related to cardiovascular and respiratory disease, which are the two most common causes of death in people living with spinal cord injury (SCI). Individuals with SCI have been reported to have higher levels of inflammation when compared to healthy individuals. Exercise is a well-known method to reduce inflammation; however, people with SCI are often inactive. The main goal of this study is to determine whether a 12-week adaptive exercise program can reduce inflammation in people with SCI. Participants will be randomized to start exercise immediately or after a 12-week delay.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide and provision of signed and dated informed consent form
- •Age 18-70
- •Diagnosis of SCI and post injury ≥ 6 months
- •Able to achieve adequate active range of motion at the elbow and wrist (flexion/extension) and able to achieve at least 90° active shoulder flexion, in order to complete study activities
排除标准
- •Non-English speaking
- •Exercise program participation ≤1 month from study enrollment or any other exercise participation during the duration of the study
- •Patients with significant cognitive impairment of any etiology that prevents them from being able to participate
- •Patients that were given sternal or spinal precautions that would prevent excessive twisting, bending, overhead reaching and lifting over 10 pounds
- •Patients with a history heart failure, chronic lung disease, angina or any other condition that causes unreasonable shortness of breath on exertion
- •Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled
- •Requires ventilator support
- •Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator
- •Pregnant, planning to become pregnant
- •Any other medical conditions that could affect their ability to participate in the exercise program (as determined by study investigators)
- •Active participation or past participation ≤3 months in any other interventional study.
- •Unwilling to participate in all study related activities
研究组 & 干预措施
Immediate start
Intervention to start immediately after first visits.
干预措施: HealthPartners NeuroWell Exercise Program (Behavioral)
Delayed start
Intervention to start after 12 weeks delay.
干预措施: HealthPartners NeuroWell Exercise Program (Behavioral)
结局指标
主要结局
Effect of Exercise on Inflammation (C-reactive Protein)
时间窗: 12 weeks
Change in C-reactive protein after 12 week exercise program
Effect of Exercise on Inflammation (Interleukin 6)
时间窗: 12 weeks
Change in Interleukin 6 after 12 week exercise program
Effect of Exercise on Inflammation (C-reactive Protein)
时间窗: 12 weeks
Change in C-reactive protein after 12 week exercise program
Effect of Exercise on Inflammation (Interleukin 6)
时间窗: 12 weeks
Change in Interleukin 6 after 12 week exercise program
Effect of Exercise on Inflammation (Tumor Necrosis)
时间窗: 12 weeks
Change in Tumor Necrosis Biomarker after 12 week exercise program
次要结局
未报告次要终点