Johns Hopkins University, Department of Neurology
Baltimore, Maryland, 21287, United States
NCT Number: NCT04027049
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21287, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 1, day 3 and day 7 of study
Time frame: Day 1, day 3 and day 7 of study
Time frame: Day 1, day 3 and day 7 of study
Time frame: Day 1, day 3 and day 7 of study
Time frame: Day 1, day 3 and day 7 of study
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Day 1, day 3 and day 7 of study
Time frame: Study days 1, 3, 7, day of transfer from the ICU or discharge, whichever comes first, assessed up to 60 days
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: Day 1 of study
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
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: Standard of care 90-day assessment
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: Day of ICU transfer or discharge, 90 day assessment
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: 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
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: On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit
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: During the 30-day follow up visit
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
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.
Johns Hopkins University
Other
Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage: a Pilot Randomized Controlled Trial of Cycle Ergometry
Acronym: BEACH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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