Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage

Not Applicable

Completed

Conditions: Acute Ischemic Stroke
Intracerebral Hemorrhage

Interventions: Device: Supine cycle ergometry of the lower extremities

Registration Number: NCT04027049

Lead Sponsor: Johns Hopkins University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supine cycle ergometry of the lower extremities	Supine cycle ergometry of the lower extremities	Patients will receive two 20 minute cycle ergometry sessions separated by at least 4 hours in addition to usual care. The cycle will be set to a gear of zero and will begin in passive mode, the patient will be able to actively cycle if patients are able.

Primary Outcome Measures

Name	Time	Method
Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)	Day 1, day 3 and day 7 of study
Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)	Day 1, day 3 and day 7 of study
Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter)	Day 1, day 3 and day 7 of study
Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)	Day 1, day 3 and day 7 of study
Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)	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)	Day 1, day 3 and day 7 of study
Change in Tumor Necrosis Factor (TNF) -Alpha Level in CSF (Picogram/Milliliter)	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)	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)	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)	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)	Day 1, day 3 and day 7 of study

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
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	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.
Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2	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.
Functional Status as Assessed by the Modified Rankin Score (mRS)	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.
Change in the Functional Status as Assessed by the Modified Rankin Score	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).
Perception of Stroke Recovery as Assessed by the Stroke Impact Scale Version 3.0	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.
Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2	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.
Health Status as Assessed by the Stroke Impact Scale Version 3.0	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.