Intracerebral HemorrhageBEACHNCT04027049
Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage
A study testing Supine cycle ergometry of the lower extremities in people with Intracerebral Hemorrhage and Acute Ischemic Stroke, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Acute Ischemic Stroke
- What is being tested?
- Supine cycle ergometry of the lower extremities
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2019to 24 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University, Department of Neurology
Baltimore, Maryland, 21287
About this study
Official title: Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage: a Pilot Randomized Controlled Trial of Cycle Ergometry
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.
- Conditions
- Intracerebral Hemorrhage, Acute Ischemic Stroke
- Being tested
- Supine cycle ergometry of the lower extremities
- Keywords
- rehabilitation, cycle ergometry
- Medical subject headings
- Cerebral Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine cycle ergometry of the lower extremitiesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Supine cycle ergometry of the lower extremities |
| Control | No intervention | Patients will receive usual care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)
Measured: Day 1, day 3 and day 7 of study
Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)
Measured: Day 1, day 3 and day 7 of study
Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter)
Measured: Day 1, day 3 and day 7 of study
Change in C Reactive Protein Level in Blood (Nanogram/Milliliter)
Measured: Day 1, day 3 and day 7 of study
Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)
Measured: Day 1, day 3 and day 7 of study
Change in Interleukin-1beta Level in Cerebrospinal Fluid (Picogram/Milliliter)
Cerebrospinal fluid (CSF) will be collected only in patients with an external ventricular drain as part of patients' care.
Measured: Day 1, day 3 and day 7 of study
Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)
CSF will be collected only in patients with an external ventricular drain as part of patients' care.
Measured: Day 1, day 3 and day 7 of study
Change in Tumor Necrosis Factor (TNF) -Alpha Level in CSF (Picogram/Milliliter)
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)
Measured: Day 1, day 3 and day 7 of study
Change in C Reactive Protein Level in CSF (Nanogram/Milliliter)
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Measured: Day 1, day 3 and day 7 of study
Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Measured: Day 1, day 3 and day 7 of study
Change in Salivary Cortisol Level (Microgram/Deciliter)
Measured: Day 1, day 3 and day 7 of study
Secondary outcomes (9)
Absolute Change in Hand-held Dynamometry Score (Pounds)
An average of three hand-held dynamometry measurements will be calculated for each measurement episode and the change over time will be measured. Grip strength is reported in pounds and compared against population and sex-based normative values.
Measured: 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
The global physical health status subscale of the Promis scale v1.2 will be used to measure pre-morbid physical health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. 10 points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population.
Measured: Day 1 of study
Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2
The global mental health status subscale of the Promis scale will be used to measure pre-morbid mental health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. Ten points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population.
Measured: Day 1 of study
Functional Status as Assessed by the Modified Rankin Score (mRS)
The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Reporting the frequency of each score category.
Measured: Standard of care 90-day assessment
Change in the Functional Status as Assessed by the Modified Rankin Score
The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Change in functional status was calculated by subtracting the first score (discharge) from the second score (90 day assessment).
Measured: Day of ICU transfer or discharge, 90 day assessment
Change in Muscle Strength as Assessed by the Medical Research Council Sum (MRCS) Score
The MRCS will be used to measure muscle strength over time. The instrument is a 60 point scale indicating muscle strength in 6 muscle groups. Three muscle groups each on the right and left upper extremities and three each in the right and left lower extremities. Each muscle group is scored from 0-5 out of a possible 5 points. A composite score with a maximum of 60 is produced, 30 points can be achieved for each side of the body.
Measured: 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
The Barthel index will be used to measure a participant's ability to perform activities of daily living in detail. The instrument is a 10-item scale with a range of 0 -100 points. Higher scores indicate higher levels of function.
Measured: 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
This is a 59-item questionnaire that will measure health status in 8 domains following the stroke. A 5-point Likert scale is used to score each item with higher scores indicating higher perceived health status.
Measured: During the 30-day follow up visit
Perception of Stroke Recovery as Assessed by the Stroke Impact Scale Version 3.0
The last question of the instrument measures a participant's perception of stroke recovery using a 0-100 scale with higher scores representing higher levels of recovery and lower scores representing less recovery.
Measured: During the 30-day follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start2 Mar 2019
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth K Zink, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027049
- Sponsor's protocol ID
- IRB00154440
- Acronym
- BEACH
- Status last verified
- Apr 2024
- First submitted
- 16 Jul 2019
- Last updated
- 1 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Amidei C, Sole ML. Physiological responses to passive exercise in adults receiving mechanical ventilation. Am J Crit Care. 2013 Jul;22(4):337-48. doi: 10.4037/ajcc2013284.
PubMed 23817823Arafah BM, Nishiyama FJ, Tlaygeh H, Hejal R. Measurement of salivary cortisol concentration in the assessment of adrenal function in critically ill subjects: a surrogate marker of the circulating free cortisol. J Clin Endocrinol Metab. 2007 Aug;92(8):2965-71. doi: 10.1210/jc.2007-0181. Epub 2007 May 29.
PubMed 17535998Burn JP. Reliability of the modified Rankin Scale. Stroke. 1992 Mar;23(3):438. No abstract available.
PubMed 1610453Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.
PubMed 19623052Calabrese EJ. Pre- and post-conditioning hormesis in elderly mice, rats, and humans: its loss and restoration. Biogerontology. 2016 Aug;17(4):681-702. doi: 10.1007/s10522-016-9646-8. Epub 2016 Apr 13.
PubMed 27075594Camargo Pires-Neto R, Fogaca Kawaguchi YM, Sayuri Hirota A, Fu C, Tanaka C, Caruso P, Park M, Ribeiro Carvalho CR. Very early passive cycling exercise in mechanically ventilated critically ill patients: physiological and safety aspects--a case series. PLoS One. 2013 Sep 9;8(9):e74182. doi: 10.1371/journal.pone.0074182. eCollection 2013.
PubMed 24040200Chen J, Qin J, Su Q, Liu Z, Yang J. Treadmill rehabilitation treatment enhanced BDNF-TrkB but not NGF-TrkA signaling in a mouse intracerebral hemorrhage model. Neurosci Lett. 2012 Oct 31;529(1):28-32. doi: 10.1016/j.neulet.2012.09.021. Epub 2012 Sep 19.
PubMed 22999926Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013 Feb;66(2):197-201. doi: 10.1016/j.jclinepi.2012.09.002. Epub 2012 Nov 27.
PubMed 23195919Di Napoli M, Godoy DA, Campi V, Masotti L, Smith CJ, Parry Jones AR, Hopkins SJ, Slevin M, Papa F, Mogoanta L, Pirici D, Popa Wagner A. C-reactive protein in intracerebral hemorrhage: time course, tissue localization, and prognosis. Neurology. 2012 Aug 14;79(7):690-9. doi: 10.1212/WNL.0b013e318264e3be. Epub 2012 Aug 1.
PubMed 22855859Duffy L, Gajree S, Langhorne P, Stott DJ, Quinn TJ. Reliability (inter-rater agreement) of the Barthel Index for assessment of stroke survivors: systematic review and meta-analysis. Stroke. 2013 Feb;44(2):462-8. doi: 10.1161/STROKEAHA.112.678615. Epub 2013 Jan 8.
PubMed 23299497Fearon P, McArthur KS, Garrity K, Graham LJ, McGroarty G, Vincent S, Quinn TJ. Prestroke modified rankin stroke scale has moderate interobserver reliability and validity in an acute stroke setting. Stroke. 2012 Dec;43(12):3184-8. doi: 10.1161/STROKEAHA.112.670422. Epub 2012 Nov 13.
PubMed 23150650Fogelholm R, Murros K, Rissanen A, Avikainen S. Long term survival after primary intracerebral haemorrhage: a retrospective population based study. J Neurol Neurosurg Psychiatry. 2005 Nov;76(11):1534-8. doi: 10.1136/jnnp.2004.055145.
PubMed 16227546Gao Z, Wang J, Thiex R, Rogove AD, Heppner FL, Tsirka SE. Microglial activation and intracerebral hemorrhage. Acta Neurochir Suppl. 2008;105:51-3. doi: 10.1007/978-3-211-09469-3_11.
PubMed 19066082Giraldo E, Garcia JJ, Hinchado MD, Ortega E. Exercise intensity-dependent changes in the inflammatory response in sedentary women: role of neuroendocrine parameters in the neutrophil phagocytic process and the pro-/anti-inflammatory cytokine balance. Neuroimmunomodulation. 2009;16(4):237-44. doi: 10.1159/000212384. Epub 2009 Apr 9.
PubMed 19365147Gomez-Cabrera MC, Domenech E, Vina J. Moderate exercise is an antioxidant: upregulation of antioxidant genes by training. Free Radic Biol Med. 2008 Jan 15;44(2):126-31. doi: 10.1016/j.freeradbiomed.2007.02.001. Epub 2007 Feb 9.
PubMed 18191748
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage: a Pilot Randomized Controlled Trial of Cycle Ergometry
- ClinicalTrials.gov ID
- NCT04027049
- Acronym / sponsor ID
- BEACH / IRB00154440
- Conditions
- Intracerebral Hemorrhage, Acute Ischemic Stroke
- Keywords
- rehabilitation, cycle ergometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Posted 1 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot randomized parallel group design
| Arm | Type | Receives |
|---|---|---|
| Supine cycle ergometry of the lower extremities | Experimental | Device: Supine cycle ergometry of the lower extremitiesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine cycle ergometry of the lower extremitiesThe 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. | Device | Supine cycle ergometry of the lower extremities |
Primary outcome
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
9 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23817823Amidei C, Sole ML. Physiological responses to passive exercise in adults receiving mechanical ventilation. Am J Crit Care. 2013 Jul;22(4):337-48. doi: 10.4037/ajcc2013284.
- Background: PubMed 17535998Arafah BM, Nishiyama FJ, Tlaygeh H, Hejal R. Measurement of salivary cortisol concentration in the assessment of adrenal function in critically ill subjects: a surrogate marker of the circulating free cortisol. J Clin Endocrinol Metab. 2007 Aug;92(8):2965-71. doi: 10.1210/jc.2007-0181. Epub 2007 May 29.
- Background: PubMed 1610453Burn JP. Reliability of the modified Rankin Scale. Stroke. 1992 Mar;23(3):438. No abstract available.
- Background: PubMed 19623052Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.
- Background: PubMed 27075594Calabrese EJ. Pre- and post-conditioning hormesis in elderly mice, rats, and humans: its loss and restoration. Biogerontology. 2016 Aug;17(4):681-702. doi: 10.1007/s10522-016-9646-8. Epub 2016 Apr 13.
- Background: PubMed 24040200Camargo Pires-Neto R, Fogaca Kawaguchi YM, Sayuri Hirota A, Fu C, Tanaka C, Caruso P, Park M, Ribeiro Carvalho CR. Very early passive cycling exercise in mechanically ventilated critically ill patients: physiological and safety aspects--a case series. PLoS One. 2013 Sep 9;8(9):e74182. doi: 10.1371/journal.pone.0074182. eCollection 2013.
- Background: PubMed 22999926Chen J, Qin J, Su Q, Liu Z, Yang J. Treadmill rehabilitation treatment enhanced BDNF-TrkB but not NGF-TrkA signaling in a mouse intracerebral hemorrhage model. Neurosci Lett. 2012 Oct 31;529(1):28-32. doi: 10.1016/j.neulet.2012.09.021. Epub 2012 Sep 19.
- Background: PubMed 23195919Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013 Feb;66(2):197-201. doi: 10.1016/j.jclinepi.2012.09.002. Epub 2012 Nov 27.
- Background: PubMed 22855859Di Napoli M, Godoy DA, Campi V, Masotti L, Smith CJ, Parry Jones AR, Hopkins SJ, Slevin M, Papa F, Mogoanta L, Pirici D, Popa Wagner A. C-reactive protein in intracerebral hemorrhage: time course, tissue localization, and prognosis. Neurology. 2012 Aug 14;79(7):690-9. doi: 10.1212/WNL.0b013e318264e3be. Epub 2012 Aug 1.
- Background: PubMed 23299497Duffy L, Gajree S, Langhorne P, Stott DJ, Quinn TJ. Reliability (inter-rater agreement) of the Barthel Index for assessment of stroke survivors: systematic review and meta-analysis. Stroke. 2013 Feb;44(2):462-8. doi: 10.1161/STROKEAHA.112.678615. Epub 2013 Jan 8.
- Background: PubMed 23150650Fearon P, McArthur KS, Garrity K, Graham LJ, McGroarty G, Vincent S, Quinn TJ. Prestroke modified rankin stroke scale has moderate interobserver reliability and validity in an acute stroke setting. Stroke. 2012 Dec;43(12):3184-8. doi: 10.1161/STROKEAHA.112.670422. Epub 2012 Nov 13.
- Background: PubMed 16227546Fogelholm R, Murros K, Rissanen A, Avikainen S. Long term survival after primary intracerebral haemorrhage: a retrospective population based study. J Neurol Neurosurg Psychiatry. 2005 Nov;76(11):1534-8. doi: 10.1136/jnnp.2004.055145.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth K Zink principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine cycle ergometry of the lower extremities in people with Intracerebral Hemorrhage and Acute Ischemic Stroke, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interleukin-1beta Level in Blood (Picogram/Milliliter) (time frame: Day 1, day 3 and day 7 of study). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027049, which also lists 51 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.