Acute Ischemic Stroke Clinical Trial
— BEACHOfficial title:
Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage: a Pilot Randomized Controlled Trial of Cycle Ergometry
Verified date | April 2024 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | February 24, 2021 |
Est. primary completion date | February 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University, Department of Neurology | Baltimore | Maryland |
Lead Sponsor | Collaborator |
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Johns Hopkins University |
United States,
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* Note: There are 51 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Interleukin-1beta Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | ||
Primary | Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | ||
Primary | Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | ||
Primary | Change in C Reactive Protein Level in Blood (Nanogram/Milliliter) | Day 1, day 3 and day 7 of study | ||
Primary | Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | ||
Primary | 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. | Day 1, day 3 and day 7 of study | |
Primary | 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. | Day 1, day 3 and day 7 of study | |
Primary | 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) | Day 1, day 3 and day 7 of study | |
Primary | Change in C Reactive Protein Level in CSF (Nanogram/Milliliter) | CSF will be collected only in patients with an external ventricular drain as part of patients' care | Day 1, day 3 and day 7 of study | |
Primary | 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 | Day 1, day 3 and day 7 of study | |
Primary | Change in Salivary Cortisol Level (Microgram/Deciliter) | Day 1, day 3 and day 7 of study | ||
Secondary | 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. | Study days 1, 3, 7, day of transfer from the ICU or discharge, whichever comes first, assessed up to 60 days | |
Secondary | 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. | Day 1 of study | |
Secondary | 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. | Day 1 of study | |
Secondary | 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. | Standard of care 90-day assessment | |
Secondary | 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). | Day of ICU transfer or discharge, 90 day assessment | |
Secondary | 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. | 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 | |
Secondary | 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. | On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit | |
Secondary | 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. | During the 30-day follow up visit | |
Secondary | 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. | During the 30-day follow up visit |
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