Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage: a Pilot Randomized Controlled Trial of Cycle Ergometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)
研究概览
简要总结
This study aims to determine whether in-bed cycle ergometry, early in the hospital course after a brain hemorrhage could balance damaging and reparative inflammation in the brain. Inflammatory factors of two groups of patients with brain hemorrhage will be compared, one group will receive in-bed cycling beginning 3 days after hemorrhage plus usual care and the other group will receive usual care only.
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
- Single (Outcomes Assessor)
盲法说明
The clinician assessing outcomes will not have been involved in the care of the patient and will not be aware of the group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Supratentorial intracerebral hemorrhage with or without intraventricular hemorrhage
- •Pre-morbid modified Rankin Score of 0-2
- •Patient must be able to provide informed consent or have a legally authorized representative to provide consent on patient's behalf
排除标准
- •Patients with known inflammatory conditions, infection requiring antibiotics or pregnancy
- •Patients receiving daily anti-inflammatory medications including but not limited to prednisone, methotrexate, non-steroidal anti-inflammatory medications (ibuprofen, naproxen, indomethacin, celecoxib) and aspirin >325mg
- •Glasgow Coma Score (GCS) 3 48 hours after admission
- •Patients in whom withdrawal of life support is being considered by surrogate decision makers
- •Injury to the lower extremities, hips or pelvis, weight >250 kg (weight limit of cycle), or body habitus precluding normal function of cycle
结局指标
主要结局
Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)
时间窗: Day 1, day 3 and day 7 of study
Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)
时间窗: Day 1, day 3 and day 7 of study
Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter)
时间窗: Day 1, day 3 and day 7 of study
Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)
时间窗: Day 1, day 3 and day 7 of study
Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)
时间窗: Day 1, day 3 and day 7 of study
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Change in C Reactive Protein Level in Blood (Nanogram/Milliliter)
时间窗: Day 1, day 3 and day 7 of study
Change in Tumor Necrosis Factor (TNF) -Alpha Level in CSF (Picogram/Milliliter)
时间窗: Day 1, day 3 and day 7 of study
CSF will be collected only in patients with an external ventricular drain as part of patients' care. TNF-alpha normal range (1.45 pg/mL to 1073.41 pg/mL)
Change in C Reactive Protein Level in CSF (Nanogram/Milliliter)
时间窗: Day 1, day 3 and day 7 of study
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Change in Interleukin-1beta Level in Cerebrospinal Fluid (Picogram/Milliliter)
时间窗: Day 1, day 3 and day 7 of study
Cerebrospinal fluid (CSF) will be collected only in patients with an external ventricular drain as part of patients' care.
Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)
时间窗: Day 1, day 3 and day 7 of study
CSF will be collected only in patients with an external ventricular drain as part of patients' care.
Change in Salivary Cortisol Level (Microgram/Deciliter)
时间窗: Day 1, day 3 and day 7 of study
次要结局
- Change in Muscle Strength as Assessed by the Medical Research Council Sum (MRCS) Score(Study days 1, 3, 7, On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit)
- Ability to Perform Activities of Daily Living as Assessed by the Barthel Index(On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit)
- Absolute Change in Hand-held Dynamometry Score (Pounds)(Study days 1, 3, 7, day of transfer from the ICU or discharge, whichever comes first, assessed up to 60 days)
- Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2(Day 1 of study)
- Functional Status as Assessed by the Modified Rankin Score (mRS)(Standard of care 90-day assessment)
- Change in the Functional Status as Assessed by the Modified Rankin Score(Day of ICU transfer or discharge, 90 day assessment)
- Perception of Stroke Recovery as Assessed by the Stroke Impact Scale Version 3.0(During the 30-day follow up visit)
- Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2(Day 1 of study)
- Health Status as Assessed by the Stroke Impact Scale Version 3.0(During the 30-day follow up visit)