Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage (BEACH)

Johns Hopkins University

Status: Completed

Conditions: Intracerebral Hemorrhage; Acute Ischemic Stroke

Treatments: Device: Supine cycle ergometry of the lower extremities

Study type: Interventional

Funder types: Other

Identifiers

NCT04027049

IRB00154440

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Supine cycle ergometry of the lower extremities

Experimental group

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.

Treatment:

Device: Supine cycle ergometry of the lower extremities

Control

No Intervention group

Description:

Patients will receive usual care only.