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Behavioural Intervention
Early Exercise for Stroke (BEACH Trial)
N/A
Recruiting
Led By Elizabeth K Zink
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pre-morbid modified Rankin Score of 0-2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 3 and day 7 of study
Awards & highlights
BEACH Trial Summary
This trial will compare the inflammatory factors of two groups of brain hemorrhage patients, one of which will receive in-bed cycling in addition to usual care.
Who is the study for?
This trial is for individuals who've had a type of brain hemorrhage and can consent to participate or have someone to consent for them. They should be relatively independent in daily activities before the stroke, not on daily anti-inflammatory meds, without severe injuries that prevent cycling, not excessively overweight, free from inflammatory conditions or infections needing antibiotics, and not pregnant.Check my eligibility
What is being tested?
The study tests if using an in-bed cycle machine early after a brain hemorrhage helps manage inflammation in the brain. Participants are divided into two groups: one does cycling plus standard care starting three days post-hemorrhage; the other receives standard care alone.See study design
What are the potential side effects?
Since this intervention involves physical activity (cycling), potential side effects may include muscle soreness or fatigue. However, as it's gentle exercise designed for hospital settings, serious side effects are unlikely but will be monitored.
BEACH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a score between 0 and 2 on the modified Rankin Scale before you got sick.
BEACH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 3 and day 7 of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 3 and day 7 of study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Brain Derived Neurotrophic Factor level in CSF (picogram/milliliter)
Change in Brain Derived Neurotrophic Factor level in blood (picogram/milliliter)
Change in C Reactive Protein level in CSF (nanogram/milliliter)
+14 moreSecondary outcome measures
Ability to perform activities of daily living as assessed by the Barthel Index
Change in hand-held dynamometry score (pounds)
Change in muscle strength as assessed by the Medical Research Council Sum (MRCS) Score
+9 moreBEACH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Supine cycle ergometry of the lower extremitiesExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Patients will receive usual care only.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,256 Previous Clinical Trials
14,820,031 Total Patients Enrolled
1 Trials studying Hemorrhagic Stroke
50 Patients Enrolled for Hemorrhagic Stroke
Elizabeth K ZinkPrincipal InvestigatorJohns Hopkins University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have bleeding in the brain, either inside or around it.You have a score between 0 and 2 on the modified Rankin Scale before you got sick.You have injuries in your legs or hips, or you weigh more than 250 kilograms and cannot use the cycle normally.You have an ongoing infection, inflammation, or are pregnant.You have a very low Glasgow Coma Score (GCS) within 48 hours of being admitted.You are currently taking certain anti-inflammatory medications every day.Your family is thinking about taking you off life support.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Supine cycle ergometry of the lower extremities
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for participants in this research?
"Per the clinicaltrials.gov website, this experiment is actively seeking participants at present. First posted on March 2nd 2019, it was last modified on January 6th 2022."
Answered by AI
How many individuals have enrolled in this research endeavor?
"Affirmative. The clinical trial is recruiting as indicated on the clinicaltrials.gov website, which was last updated in January 6th 2022 and initially posted on March 2nd 2019. This medical study requires 40 participants at a single site."
Answered by AI
What are the main aims of this research endeavor?
"The primary aim of this experiment, which will be assessed on Day 1, 3 and 7, is to measure the amount of interleukin-1beta in the blood. Secondary endpoints include Functional status as measured by a Modified Rankin Score (MRS) rating from 0-6 (with 6 indicating death), fatigue as evaluated using Promis Scale v1.2 with higher scores illustrating less weariness, and Hand-held dynamometry score (pounds)."
Answered by AI
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