Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage (BEACH)

April 5, 2024 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
No Intervention: Control
Patients will receive usual care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)
Time Frame: Day 1, day 3 and day 7 of study
Day 1, day 3 and day 7 of study
Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)
Time Frame: Day 1, day 3 and day 7 of study
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
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
Day 1, day 3 and day 7 of study
Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)
Time Frame: Day 1, day 3 and day 7 of study
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.
Day 1, day 3 and day 7 of study
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.
Day 1, day 3 and day 7 of study
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)
Day 1, day 3 and day 7 of study
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
Day 1, day 3 and day 7 of study
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
Day 1, day 3 and day 7 of study
Change in Salivary Cortisol Level (Microgram/Deciliter)
Time Frame: Day 1, day 3 and day 7 of study
Day 1, day 3 and day 7 of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Study days 1, 3, 7, day of transfer from the ICU or discharge, whichever comes first, assessed up to 60 days
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.
Day 1 of study
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.
Day 1 of study
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.
Standard of care 90-day assessment
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).
Day of ICU transfer or discharge, 90 day assessment
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.
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
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.
On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit
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.
During the 30-day follow up visit
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.
During the 30-day follow up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Elizabeth K Zink, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2019

Primary Completion (Actual)

February 24, 2021

Study Completion (Actual)

February 24, 2021

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00154440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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