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Completed

NCT Number: NCT04027049

Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University, Department of Neurology

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supine cycle ergometry of the lower extremities

Device

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.

Primary outcomes

  1. Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)

    Time frame: Day 1, day 3 and day 7 of study

  2. Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)

    Time frame: Day 1, day 3 and day 7 of study

  3. Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter)

    Time frame: Day 1, day 3 and day 7 of study

  4. Change in C Reactive Protein Level in Blood (Nanogram/Milliliter)

    Time frame: Day 1, day 3 and day 7 of study

  5. Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)

    Time frame: Day 1, day 3 and day 7 of study

  6. Change in Interleukin-1beta Level in Cerebrospinal Fluid (Picogram/Milliliter)

    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.

  7. Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)

    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.

  8. Change in Tumor Necrosis Factor (TNF) -Alpha Level in CSF (Picogram/Milliliter)

    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)

  9. Change in C Reactive Protein Level in CSF (Nanogram/Milliliter)

    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

  10. Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)

    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

  11. Change in Salivary Cortisol Level (Microgram/Deciliter)

    Time frame: Day 1, day 3 and day 7 of study

Secondary outcomes

  1. Absolute Change in Hand-held Dynamometry Score (Pounds)

    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.

  2. Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2

    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.

  3. Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2

    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.

  4. Functional Status as Assessed by the Modified Rankin Score (mRS)

    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.

  5. Change in the Functional Status as Assessed by the Modified Rankin Score

    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).

  6. Change in Muscle Strength as Assessed by the Medical Research Council Sum (MRCS) Score

    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.

  7. Ability to Perform Activities of Daily Living as Assessed by the Barthel Index

    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.

  8. Health Status as Assessed by the Stroke Impact Scale Version 3.0

    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.

  9. Perception of Stroke Recovery as Assessed by the Stroke Impact Scale Version 3.0

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Acronym: BEACH

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2019
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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