N/A N=25 Randomized Single-blind Treatment

Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage

Intracerebral Hemorrhage · Acute Ischemic Stroke

Bottom Line

View on ClinicalTrials.gov: NCT04027049 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Supine cycle ergometry of the lower extremities (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)	—	—
PRIMARY Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)	7.01; 6.18; 4.3; 4.59; 2.94; 3.17	—
PRIMARY Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter)	—	—
PRIMARY Change in C Reactive Protein Level in Blood (Nanogram/Milliliter)	—	—
PRIMARY Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)	8038.53; 2554.34; 4380.57; 3043.86; 3979.26; 2494.29	—
PRIMARY Change in Interleukin-1beta Level in Cerebrospinal Fluid (Picogram/Milliliter)	—	—
PRIMARY Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)	1659; 158.79; 3379.57; 386.02; 2729.16; 19.2	—
PRIMARY Change in Tumor Necrosis Factor (TNF) -Alpha Level in CSF (Picogram/Milliliter)	—	—
PRIMARY Change in C Reactive Protein Level in CSF (Nanogram/Milliliter)	—	—
PRIMARY Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)	26.26; 3.71; 12.42; 2.64; 4.38; 2.75	—
PRIMARY Change in Salivary Cortisol Level (Microgram/Deciliter)	—	—
SECONDARY Absolute Change in Hand-held Dynamometry Score (Pounds)	28.8; 25.7; 19.87; 24.55; 21.2; 33.6	—
SECONDARY Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2	38.6; 44.9	—
SECONDARY Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2	53.3; 41.15	—
SECONDARY Functional Status as Assessed by the Modified Rankin Score (mRS)	0; 0; 2; 0; 1; 3	—
SECONDARY Change in the Functional Status as Assessed by the Modified Rankin Score	0; 2; -1; 2	—
SECONDARY Change in Muscle Strength as Assessed by the Medical Research Council Sum (MRCS) Score	—	—
SECONDARY Ability to Perform Activities of Daily Living as Assessed by the Barthel Index	10; 5	—
SECONDARY Health Status as Assessed by the Stroke Impact Scale Version 3.0	—	—
SECONDARY Perception of Stroke Recovery as Assessed by the Stroke Impact Scale Version 3.0	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04027049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.