Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage

Acute Ischemic Stroke Clinical Trial

— BEACH  

Official title:

Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage: a Pilot Randomized Controlled Trial of Cycle Ergometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027049
• Other study ID #: IRB00154440
• Status: Completed
• Phase: N/A
• Start date: March 2, 2019
• Est. completion date: February 24, 2021

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemic Stroke

Intervention

Device:
• Supine cycle ergometry of the lower extremities
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.

Locations

Country	Name	City	State
United States	Johns Hopkins University, Department of Neurology	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (51)

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* Note: There are 51 references in all — Click here to view all references

Outcome

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