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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
The cycle ergometer allows for movement of the lower extremities by a motor if a patient is experiencing a disorder of consciousness or is otherwise unable to move one or both legs. If a patient is able to cycle actively the device allows the patient to move patient's legs without support of the motor.
Johns Hopkins University, Department of Neurology
Baltimore, Maryland, United States
Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)
Time frame: Day 1, day 3 and day 7 of study
Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)
Time frame: Day 1, day 3 and day 7 of study
Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter)
Time frame: Day 1, day 3 and day 7 of study
Change in C Reactive Protein Level in Blood (Nanogram/Milliliter)
Time frame: Day 1, day 3 and day 7 of study
Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)
Time frame: Day 1, day 3 and day 7 of study
Change in Interleukin-1beta Level in Cerebrospinal Fluid (Picogram/Milliliter)
Cerebrospinal fluid (CSF) will be collected only in patients with an external ventricular drain as part of patients' care.
Time frame: Day 1, day 3 and day 7 of study
Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)
CSF will be collected only in patients with an external ventricular drain as part of patients' care.
Time frame: Day 1, day 3 and day 7 of study
Change in Tumor Necrosis Factor (TNF) -Alpha Level in CSF (Picogram/Milliliter)
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)
Time frame: Day 1, day 3 and day 7 of study
Change in C Reactive Protein Level in CSF (Nanogram/Milliliter)
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CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time frame: Day 1, day 3 and day 7 of study
Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time frame: Day 1, day 3 and day 7 of study
Change in Salivary Cortisol Level (Microgram/Deciliter)
Time frame: Day 1, day 3 and day 7 of study
Absolute Change in Hand-held Dynamometry Score (Pounds)
An average of three hand-held dynamometry measurements will be calculated for each measurement episode and the change over time will be measured. Grip strength is reported in pounds and compared against population and sex-based normative values.
Time frame: Study days 1, 3, 7, day of transfer from the ICU or discharge, whichever comes first, assessed up to 60 days
Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2
The global physical health status subscale of the Promis scale v1.2 will be used to measure pre-morbid physical health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. 10 points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population.
Time frame: Day 1 of study
Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2
The global mental health status subscale of the Promis scale will be used to measure pre-morbid mental health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. Ten points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population.
Time frame: Day 1 of study
Functional Status as Assessed by the Modified Rankin Score (mRS)
The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Reporting the frequency of each score category.
Time frame: Standard of care 90-day assessment
Change in the Functional Status as Assessed by the Modified Rankin Score
The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Change in functional status was calculated by subtracting the first score (discharge) from the second score (90 day assessment).
Time frame: Day of ICU transfer or discharge, 90 day assessment
Change in Muscle Strength as Assessed by the Medical Research Council Sum (MRCS) Score
The MRCS will be used to measure muscle strength over time. The instrument is a 60 point scale indicating muscle strength in 6 muscle groups. Three muscle groups each on the right and left upper extremities and three each in the right and left lower extremities. Each muscle group is scored from 0-5 out of a possible 5 points. A composite score with a maximum of 60 is produced, 30 points can be achieved for each side of the body.
Time frame: 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
The Barthel index will be used to measure a participant's ability to perform activities of daily living in detail. The instrument is a 10-item scale with a range of 0 -100 points. Higher scores indicate higher levels of function.
Time frame: On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit
Health Status as Assessed by the Stroke Impact Scale Version 3.0
This is a 59-item questionnaire that will measure health status in 8 domains following the stroke. A 5-point Likert scale is used to score each item with higher scores indicating higher perceived health status.
Time frame: During the 30-day follow up visit
Perception of Stroke Recovery as Assessed by the Stroke Impact Scale Version 3.0
The last question of the instrument measures a participant's perception of stroke recovery using a 0-100 scale with higher scores representing higher levels of recovery and lower scores representing less recovery.
Time frame: During the 30-day follow up visit