N/A
Completed N=25
Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage
Source: ClinicalTrials.gov NCT04027049 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)
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.
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 |
— | — |
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
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. Informational only — not medical advice.