Back to resultsBiologic Mechanisms of Early Exercise After Intracerebral Hemorrhage (BEACH)
Primary Purpose
Intra Cerebral Hemorrhage, Stroke Hemorrhagic
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supine cycle ergometry of the lower extremities
Sponsored by
About this trial
This is an interventional treatment trial for Intra Cerebral Hemorrhage focused on measuring rehabilitation, cycle ergometry
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Supine cycle ergometry of the lower extremities
Control
Arm Description
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.
Patients will receive usual care only.
Outcomes
Primary Outcome Measures
Change in interleukin-1beta level in blood (picogram/milliliter)
Change in Interleukin-6 level in blood (picogram/milliliter)
Change in Tumor Necrosis Factor-alpha level in blood (picogram/milliliter)
Change in C Reactive Protein level in blood (nanogram/milliliter)
Change in Brain Derived Neurotrophic Factor level in blood (picogram/milliliter)
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.
Coefficient of correlation between interleukin-1beta level in CSF and blood
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Change in salivary cortisol level (microgram/deciliter)
Secondary Outcome Measures
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.
Hand-held dynamometry score (pounds)
An average of three hand-held dynamometry measurements will be calculated.
Hand-held dynamometry score (pounds)
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT04027049
First Posted
July 16, 2019
Last Updated
January 23, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT04027049
Brief Title
Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage
Acronym
BEACH
Official Title
Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage: a Pilot Randomized Controlled Trial of Cycle Ergometry
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra Cerebral Hemorrhage, Stroke Hemorrhagic
Keywords
rehabilitation, cycle ergometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot randomized parallel group design
Masking
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.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supine cycle ergometry of the lower extremities
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will receive usual care only.
Intervention Type
Device
Intervention Name(s)
Supine cycle ergometry of the lower extremities
Intervention Description
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 Outcome Measure Information:
Title
Change in interleukin-1beta level in blood (picogram/milliliter)
Time Frame
Day 1, day 3 and day 7 of study
Title
Change in Interleukin-6 level in blood (picogram/milliliter)
Time Frame
Day 1, day 3 and day 7 of study
Title
Change in Tumor Necrosis Factor-alpha level in blood (picogram/milliliter)
Time Frame
Day 1, day 3 and day 7 of study
Title
Change in C Reactive Protein level in blood (nanogram/milliliter)
Time Frame
Day 1, day 3 and day 7 of study
Title
Change in Brain Derived Neurotrophic Factor level in blood (picogram/milliliter)
Time Frame
Day 1, day 3 and day 7 of study
Title
Change in interleukin-1beta level in cerebrospinal fluid (picogram/milliliter)
Description
Cerebrospinal fluid (CSF) will be collected only in patients with an external ventricular drain as part of patients' care.
Time Frame
Day 1, day 3 and day 7 of study
Title
Coefficient of correlation between interleukin-1beta level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 1 of study
Title
Coefficient of correlation between interleukin-1beta level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care.
Time Frame
Day 3 of study
Title
Coefficient of correlation between interleukin-1beta level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 7 of study
Title
Change in Interleukin-6 level in CSF (picogram/milliliter)
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care.
Time Frame
Day 1, day 3 and day 7 of study
Title
Coefficient of correlation between Interleukin-6 level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care.
Time Frame
Day 1 of study
Title
Coefficient of correlation between Interleukin-6 level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care.
Time Frame
Day 3 of study
Title
Coefficient of correlation between Interleukin-6 level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care.
Time Frame
Day 7 of study
Title
Change in tumor Necrosis Factor-alpha level in CSF (picogram/milliliter)
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 1, day 3 and day 7 of study
Title
Coefficient of correlation between tumor Necrosis Factor-alpha level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 1 of study
Title
Coefficient of correlation between tumor Necrosis Factor-alpha level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 3 of study
Title
Coefficient of correlation between tumor Necrosis Factor-alpha level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 7 of study
Title
Change in C Reactive Protein level in CSF (nanogram/milliliter)
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 1, day 3 and day 7 of study
Title
Coefficient of correlation between C Reactive Protein level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 1 of study
Title
Coefficient of correlation between C Reactive Protein level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 3 of study
Title
Coefficient of correlation between C Reactive Protein level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 7 of study
Title
Change in Brain Derived Neurotrophic Factor level in CSF (picogram/milliliter)
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 1, day 3 and day 7 of study
Title
Coefficient of correlation between Brain Derived Neurotrophic Factor levels in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 1 of study
Title
Coefficient of correlation between Brain Derived Neurotrophic Factor level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 3 of study
Title
Coefficient of correlation between Brain Derived Neurotrophic Factor level in CSF and blood
Description
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time Frame
Day 7 of study
Title
Change in salivary cortisol level (microgram/deciliter)
Time Frame
Day 1, day 3 and day 7 of study
Secondary Outcome Measure Information:
Title
Change in hand-held dynamometry score (pounds)
Description
An average of three hand-held dynamometry measurements will be calculated for each measurement episode and the change over time will be measured.
Time Frame
Daily on study days 1-7
Title
Hand-held dynamometry score (pounds)
Description
An average of three hand-held dynamometry measurements will be calculated.
Time Frame
On the day of transfer from the ICU or discharge, whichever comes first, assessed up to 60 days
Title
Hand-held dynamometry score (pounds)
Description
An average of three hand-held dynamometry measurements will be calculated.
Time Frame
At 30-day follow-up visit
Title
Global pre-morbid physical health status as measured by the Promis Scale v1.2
Description
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.
Time Frame
Day 1 of study
Title
Global pre-morbid mental health status as measured by the Promis Scale v1.2
Description
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.
Time Frame
Day 1 of study
Title
Global pre-morbid pain status as measured by the Promis Scale v1.2
Description
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.
Time Frame
Day 1 of study
Title
Global pre-morbid fatigue as measured by the Promis Scale v1.2
Description
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.
Time Frame
Day 1 of study
Title
Functional status as assessed by the Modified Rankin Score
Description
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.
Time Frame
On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days
Title
Functional status as assessed by the Modified Rankin Score
Description
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.
Time Frame
During the 30-day follow-up visit
Title
Change in muscle strength as assessed by the Medical Research Council Sum (MRCS) Score
Description
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.
Time Frame
Daily on study days 1-7
Title
Muscle strength as assessed by the Medical Research Council Sum (MRCS) Score
Description
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.
Time Frame
On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days
Title
Muscle strength as assessed by the Medical Research Council Sum (MRCS) Score
Description
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.
Time Frame
During the 30-day follow-up visit
Title
Ability to perform activities of daily living as assessed by the Barthel Index
Description
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.
Time Frame
On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days
Title
Ability to perform activities of daily living as assessed by the Barthel Index
Description
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.
Time Frame
During the 30-day follow-up visit
Title
Health status as assessed by the Stroke Impact Scale version 3.0
Description
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.
Time Frame
During the 30-day follow up visit
Title
Perception of stroke recovery as assessed by the Stroke Impact Scale version 3.0
Description
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.
Time Frame
During the 30-day follow up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth K Zink, RN, PhD(c)
Phone
410-502-5726
Email
ezink1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy C Ziai, MD, MPH
Email
weziai@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth K Zink
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth K Zink, RN, PhD(c)
Phone
410-502-5726
Email
ezink1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Wendy C Ziai, MD, MPH
Email
weziai@jhmi.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage
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