Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage

NCT04027049 | Completed Results FDA Device

• 1 other identifier: IRB00154440
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage; Acute Ischemic Stroke

Keywords

rehabilitation; cycle ergometry

Outcome Measures

Primary Outcomes (11)

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

  Day 1, day 3 and day 7 of study

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

  Day 1, day 3 and day 7 of study

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

  Day 1, day 3 and day 7 of study

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

  Day 1, day 3 and day 7 of study

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

  Day 1, day 3 and day 7 of study

• 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

• 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

• 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

• 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

• 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

• Change in Salivary Cortisol Level (Microgram/Deciliter)

  Day 1, day 3 and day 7 of study

Secondary Outcomes (9)

• Absolute Change in Hand-held Dynamometry Score (Pounds)

  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

  Day 1 of study

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

  Day 1 of study

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

  Standard of care 90-day assessment

• Change in the Functional Status as Assessed by the Modified Rankin Score

  Day of ICU transfer or discharge, 90 day assessment

Study Arms (2)

Supine cycle ergometry of the lower extremities

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients will receive usual care only.

Interventions

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.

Supine cycle ergometry of the lower extremities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University, Department of Neurology

Baltimore, Maryland, 21287, United States

Location

Related Publications (51)

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MeSH Terms

Conditions

Cerebral Hemorrhage; Ischemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Limitations and Caveats

Data from the first 25 patients enrolled in this study was analyzed. However, recruitment was thought to be affected by the COVID-19 pandemic. The investigator intended to resume recruitment of the remainder of the sample, however additional funding was not available.

Results Point of Contact

• Title: Department of Neurology
• Organization: Johns Hopkins University

ezink1@jhmi.edu

410-955-2228

Study Officials

• Elizabeth K Zink

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinician assessing outcomes will not have been involved in the care of the patient and will not be aware of the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot randomized parallel group design

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 19, 2019
• Study Start: March 2, 2019
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: May 1, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)