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Blood Flow Restriction Exercise for Spinal Cord Injury
N/A
Recruiting
Led By John McDaniel, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be between the ages of 18 and 75 years
All participants must be between the ages of 18 and 70 years and have a medically stable incomplete spinal cord injury (AIS C or D) at least 1-year post injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 1, 28 and 56 days
Awards & highlights
Study Summary
This trial will explore the benefits and risks of blood flow restriction exercise for people with incomplete spinal cord injuries.
Who is the study for?
This trial is for adults aged 18-70 with a stable incomplete spinal cord injury (AIS C or D), at least one year post-injury, and an injury level between C3-L1. It's not for pregnant women, those needing ventilators, with significant diseases like heart disease or uncontrolled diabetes, chronic inflammatory conditions, obesity (>30% body fat), recent or repeated DVTs history, on vasodilators, or with orthopedic issues preventing knee exercises.Check my eligibility
What is being tested?
The study tests the effectiveness of Blood Flow Restriction (BFR) exercise versus traditional resistance exercise in improving muscle and vascular function in individuals with spinal cord injuries. Participants will undergo two 8-week training periods focusing on knee extension/flexion exercises to compare changes in muscle strength and endurance as well as vascular health.See study design
What are the potential side effects?
Potential side effects may include increased risk of blood clots due to temporary blood stasis from BFR exercise. The safety aspect will be closely monitored by checking immune activation markers and thrombosis risk through regular blood tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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I am 18-70 years old with a stable spinal cord injury for over a year.
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My spinal cord injury is between the C3 and L1 vertebrae.
Select...
My spinal cord injury is between C3 and L1.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 1, 28 and 56 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 1, 28 and 56 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in D-dimer
Change in muscle cross sectional area
Change in muscle fatigue resistance (percent decrease in maximal voluntary torque following fatigue protocol)
+5 moreSecondary outcome measures
Change in C-reactive protein (CRP)
Change in Hypoxia-inducible factor 1-alpha (HIF-1 )
Change in Interleukin 6
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: blood flow restriction exerciseExperimental Treatment1 Intervention
8 weeks (20 sessions) of blood flow restriction knee extension/flexion exercise
Group II: traditional resistance exerciseActive Control1 Intervention
8 weeks (20 sessions) of traditional knee extension/flexion resistance exercise
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,431 Total Patients Enrolled
John McDaniel, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considered obese based on body fat measurements.You have a condition causing uncontrollable muscle stiffness or a history of frequent sudden increases in blood pressure.I am currently taking medication to widen my blood vessels.I am between 18 and 75 years old.You need a machine to help you breathe.I can't do knee exercises due to orthopaedic issues, not including weakness from my spinal cord injury.I am 18-70 years old with a stable spinal cord injury for over a year.I have had more than one blood clot in my veins or one in the last year.I do not have serious ongoing health issues like heart disease, kidney problems, uncontrolled diabetes or blood disorders.I have a chronic inflammatory condition like MS or rheumatoid arthritis.I have had a stable partial spinal cord injury for over a year.My spinal cord injury is between the C3 and L1 vertebrae.My spinal cord injury is between C3 and L1.
Research Study Groups:
This trial has the following groups:- Group 1: traditional resistance exercise
- Group 2: blood flow restriction exercise
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 younger adults being considered as participants for this experiment?
"This medical trial requires all participants to be at least 18 years of age and not exceed the age of 70."
Answered by AI
Are there any available enrollments for this research endeavor?
"Clinicaltrials.gov indicates that this clinical trial continues to seek participants since its initial posting on July 1st 2021; the page was last updated on August 11th 2022."
Answered by AI
How many individuals have signed up to participate in this research?
"Affirmative. Clinicaltrials.gov hosts data which indicates that the recruitment process for this medical study, initially posted on July 1st 2021, is ongoing. 22 patients need to be found from a single research site."
Answered by AI
Am I eligible to be a contributing participant in this experiment?
"Individuals with spinal cord injury and aged between 18 to 70 are eligible for this trial. The total number of participants being accepted is 22 people."
Answered by AI
What are the major goals of this particular experiment?
"This trial will span 0 to 56 days with the primary purpose of examining changes in D-dimer levels. Secondary objectives include investigating modifications in interferon, NETosis, and reactive hyperemia via blood samples for analysis, NIRS (near infrared spectroscopy) imaging and Doppler/ultrasound scanning respectively."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Louis Stokes VA Medical Center, Cleveland, OH
What portion of applicants met pre-screening criteria?
Did not meet criteria
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