Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage
NCT ID: NCT04027049
Last Updated: 2024-05-01
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-03-02
Study Completion Date
2021-02-24
Brief Summary
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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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Detailed Description
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Conditions
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Intracerebral Hemorrhage
Acute Ischemic Stroke
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Pilot randomized parallel group design
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
The clinician assessing outcomes will not have been involved in the care of the patient and will not be aware of the group assignment.
Study Groups
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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.
Group Type
EXPERIMENTAL
Supine cycle ergometry of the lower extremities
Intervention Type
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.
Control
Patients will receive usual care only.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
DEVICE
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Johns Hopkins University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Elizabeth K Zink
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University, Department of Neurology
Baltimore, Maryland, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00154440
Identifier Type: -
Identifier Source: org_study_id
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