---
title: Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage
nct_id: NCT04027049
overall_status: COMPLETED
phase: NA
sponsor: Johns Hopkins University
study_type: INTERVENTIONAL
primary_condition: Intracerebral Hemorrhage
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04027049.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04027049"
ct_last_update_post_date: 2024-05-01
last_seen_at: "2026-05-12T07:30:36.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage

**Official Title:** Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage: a Pilot Randomized Controlled Trial of Cycle Ergometry

**NCT ID:** [NCT04027049](https://clinicaltrials.gov/study/NCT04027049)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 25
- **Lead Sponsor:** Johns Hopkins University
- **Conditions:** Intracerebral Hemorrhage, Acute Ischemic Stroke
- **Start Date:** 2019-03-02
- **Completion Date:** 2021-02-24
- **CT.gov Last Update:** 2024-05-01

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.
- **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.

## Primary Outcomes

- **Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)** _(time frame: Day 1, day 3 and day 7 of study)_
- **Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)** _(time frame: Day 1, day 3 and day 7 of study)_
- **Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter)** _(time frame: Day 1, day 3 and day 7 of study)_
- **Change in C Reactive Protein Level in Blood (Nanogram/Milliliter)** _(time frame: Day 1, day 3 and day 7 of study)_
- **Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)** _(time frame: Day 1, day 3 and day 7 of study)_
- **Change in Interleukin-1beta Level in Cerebrospinal Fluid (Picogram/Milliliter)** _(time frame: Day 1, day 3 and day 7 of study)_ — Cerebrospinal fluid (CSF) will be collected only in patients with an external ventricular drain as part of patients' care.
- **Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)** _(time frame: Day 1, day 3 and day 7 of study)_ — CSF will be collected only in patients with an external ventricular drain as part of patients' care.
- **Change in Tumor Necrosis Factor (TNF) -Alpha Level in CSF (Picogram/Milliliter)** _(time frame: Day 1, day 3 and day 7 of study)_ — 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)
- **Change in C Reactive Protein Level in CSF (Nanogram/Milliliter)** _(time frame: Day 1, day 3 and day 7 of study)_ — CSF will be collected only in patients with an external ventricular drain as part of patients' care
- **Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)** _(time frame: Day 1, day 3 and day 7 of study)_ — CSF will be collected only in patients with an external ventricular drain as part of patients' care
- **Change in Salivary Cortisol Level (Microgram/Deciliter)** _(time frame: Day 1, day 3 and day 7 of study)_

## Secondary Outcomes

- **Absolute Change in Hand-held Dynamometry Score (Pounds)** _(time frame: 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** _(time frame: Day 1 of study)_
- **Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2** _(time frame: Day 1 of study)_
- **Functional Status as Assessed by the Modified Rankin Score (mRS)** _(time frame: Standard of care 90-day assessment)_
- **Change in the Functional Status as Assessed by the Modified Rankin Score** _(time frame: Day of ICU transfer or discharge, 90 day assessment)_
- **Change in Muscle Strength as Assessed by the Medical Research Council Sum (MRCS) Score** _(time frame: Study days 1, 3, 7, On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit)_
- **Ability to Perform Activities of Daily Living as Assessed by the Barthel Index** _(time frame: On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit)_
- **Health Status as Assessed by the Stroke Impact Scale Version 3.0** _(time frame: During the 30-day follow up visit)_
- **Perception of Stroke Recovery as Assessed by the Stroke Impact Scale Version 3.0** _(time frame: During the 30-day follow up visit)_

## Locations (1)

- Johns Hopkins University, Department of Neurology, Baltimore, Maryland, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.johns hopkins university, department of neurology|baltimore|maryland|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04027049.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04027049*  
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