Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage (BEACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04027049
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date July 19, 2019
Actual Study Start Date  ICMJE March 2, 2019
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Change in interleukin-1beta level in blood (picogram/milliliter) [ Time Frame: Day 1, day 3 and day 7 of study ]
  • Change in Interleukin-6 level in blood (picogram/milliliter) [ Time Frame: Day 1, day 3 and day 7 of study ]
  • Change in Tumor Necrosis Factor-alpha level in blood (picogram/milliliter) [ Time Frame: Day 1, day 3 and day 7 of study ]
  • Change in C Reactive Protein level in blood (nanogram/milliliter) [ Time Frame: Day 1, day 3 and day 7 of study ]
  • Change in Brain Derived Neurotrophic Factor level in blood (picogram/milliliter) [ Time Frame: Day 1, day 3 and day 7 of study ]
  • 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.
  • Coefficient of correlation between interleukin-1beta level in CSF and blood [ Time Frame: Day 1 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care
  • Coefficient of correlation between interleukin-1beta level in CSF and blood [ Time Frame: Day 3 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care.
  • Coefficient of correlation between interleukin-1beta level in CSF and blood [ Time Frame: Day 7 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care
  • 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.
  • Coefficient of correlation between Interleukin-6 level in CSF and blood [ Time Frame: Day 1 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care.
  • Coefficient of correlation between Interleukin-6 level in CSF and blood [ Time Frame: Day 3 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care.
  • Coefficient of correlation between Interleukin-6 level in CSF and blood [ Time Frame: Day 7 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care.
  • Change in tumor Necrosis Factor-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
  • Coefficient of correlation between tumor Necrosis Factor-alpha level in CSF and blood [ Time Frame: Day 1 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care
  • Coefficient of correlation between tumor Necrosis Factor-alpha level in CSF and blood [ Time Frame: Day 3 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care
  • Coefficient of correlation between tumor Necrosis Factor-alpha level in CSF and blood [ Time Frame: 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 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
  • Coefficient of correlation between C Reactive Protein level in CSF and blood [ Time Frame: Day 1 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care
  • Coefficient of correlation between C Reactive Protein level in CSF and blood [ Time Frame: Day 3 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care
  • Coefficient of correlation between C Reactive Protein level in CSF and blood [ Time Frame: Day 7 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care
  • 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
  • Coefficient of correlation between Brain Derived Neurotrophic Factor levels in CSF and blood [ Time Frame: Day 1 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care
  • Coefficient of correlation between Brain Derived Neurotrophic Factor level in CSF and blood [ Time Frame: Day 3 of study ]
    CSF will be collected only in patients with an external ventricular drain as part of patients' care
  • Coefficient of correlation between Brain Derived Neurotrophic Factor level in CSF and blood [ Time Frame: 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) [ Time Frame: Day 1, day 3 and day 7 of study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Change in hand-held dynamometry score (pounds) [ Time Frame: Daily on study days 1-7 ]
    An average of three hand-held dynamometry measurements will be calculated for each measurement episode and the change over time will be measured.
  • Hand-held dynamometry score (pounds) [ Time Frame: On the 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.
  • Hand-held dynamometry score (pounds) [ Time Frame: At 30-day follow-up visit ]
    An average of three hand-held dynamometry measurements will be calculated.
  • 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.
  • 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 mental health status.
  • Global pre-morbid pain status as measured by the Promis Scale v1.2 [ Time Frame: Day 1 of study ]
    The pain subscale of the Promis scale of global health will be used to measure pre-morbid pain status. A 10 point visual analog scale is used with higher scores indicating greater pain levels. Raw scores will be used for analysis.
  • Global pre-morbid fatigue as measured by the Promis Scale v1.2 [ Time Frame: Day 1 of study ]
    The fatigue subscle of the Promis scale of global health will be used to measure pre-morbid fatigue status. A 5 point Likert scale is used with higher scores indicating no fatigue and lower scores indicating increasing levels of fatigue. Raw scores will be used for analysis.
  • Functional status as assessed by the Modified Rankin Score [ Time Frame: On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days ]
    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.
  • Functional status as assessed by the Modified Rankin Score [ Time Frame: During the 30-day follow-up visit ]
    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 muscle strength as assessed by the Medical Research Council Sum (MRCS) Score [ Time Frame: Daily on study days 1-7 ]
    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.
  • Muscle strength as assessed by the Medical Research Council Sum (MRCS) Score [ Time Frame: On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days ]
    The MRCS will be used to measure muscle strength. 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.
  • Muscle strength as assessed by the Medical Research Council Sum (MRCS) Score [ Time Frame: During the 30-day follow-up visit ]
    The MRCS will be used to measure muscle strength. 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 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 [ Time Frame: On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days ]
    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 maximum of 100 points. Higher scores indicate higher levels of function.
  • Ability to perform activities of daily living as assessed by the Barthel Index [ Time Frame: During the 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 maximum of 100 points. Higher scores indicate higher levels of function.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage
Official Title  ICMJE Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage: a Pilot Randomized Controlled Trial of Cycle Ergometry
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pilot randomized parallel group design
Masking: Single (Outcomes Assessor)
Masking Description:
The clinician assessing outcomes will not have been involved in the care of the patient and will not be aware of the group assignment.
Primary Purpose: Treatment
Condition  ICMJE
  • Intra Cerebral Hemorrhage
  • Stroke Hemorrhagic
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Device: Supine cycle ergometry of the lower extremities
  • No Intervention: Control
    Patients will receive usual care only.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth K Zink, RN, PhD(c) 410-502-5726 ezink1@jhmi.edu
Contact: Wendy C Ziai, MD, MPH weziai@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04027049
Other Study ID Numbers  ICMJE IRB00154440
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizabeth K Zink Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP