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Acute Exercise for Spinal Cord Injury (IBSCI Trial)
N/A
Recruiting
Led By Adam J. Sterczala, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; at rest
Awards & highlights
IBSCI Trial Summary
This trial will study how a protein called irisin affects bone health in people with spinal cord injuries. It will also look at how different types of muscle fibers influence irisin levels and if exercise can increase irisin concentrations.
Who is the study for?
This trial is for adults over 18 with a spinal cord injury (SCI) at the cervical level 4 or lower, occurring at least one year ago. They must be able to use an arm ergometer and perform wheelchair transfers independently. Excluded are those with bone metabolic disorders, recent hospitalizations, cardiorespiratory issues, certain medication usage affecting bone metabolism, upper limb pain that affects exercise ability, or conditions making vigorous exercise unsafe.Check my eligibility
What is being tested?
The study investigates how acute exercise influences irisin levels in the blood and its relationship to bone health in individuals with SCI. It also explores if muscle fiber type affects irisin levels and aims to find an exercise method to boost these concentrations.See study design
What are the potential side effects?
Since this trial involves acute physical exercise as the intervention rather than medication or invasive procedures, side effects may include typical post-exercise symptoms such as muscle soreness or fatigue but should not involve severe adverse reactions.
IBSCI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and immediately post-exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and immediately post-exercise
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Exercise induced change in irisin concentration
FNDC5 gene expression
Irisin - Bone measure correlations
IBSCI Trial Design
2Treatment groups
Active Control
Group I: Individuals with SCIActive Control1 Intervention
Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
Group II: Controls (No SCI)Active Control1 Intervention
Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,240 Total Patients Enrolled
Adam J. Sterczala, PhDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- People who are 18 years old or older with spinal cord injury.You have a spinal cord injury at the level of the neck or lower that happened at least 12 months ago.You have a bone-related condition like Paget's disease or a bone disorder related to kidney problems.You cannot join this study if you are already taking part in another study that has more than minimal risk.You have been in the hospital for any reason in the last three months.You have a history of heart or lung problems like coronary artery disease or coronary bypass surgery.You have had a broken bone or dislocated joint in your upper body that has not fully healed.You have been in the hospital for any reason in the last three months.You have a spinal cord injury and are likely to have significant issues with blood pressure and other bodily functions during intense exercise.Your primary care doctor thinks you shouldn't do intense arm exercise testing or vigorous exercise because of other health conditions.You are already taking part in another study that involves more than minimal risk.You need to have enough strength and use of your arms to operate a special bike during the study.You have a medical condition that your main doctor says makes it unsafe for you to have a muscle biopsy from your vastus lateralis muscle.You can move to and from a wheelchair by yourself.Control participants should be the same age and gender as the participants with spinal cord injury.You are taking certain medications that can affect bone health, such as steroids or hormone treatments.You are actively taking certain medications that could affect your bone health, such as hormones, steroids, or specific drugs for more than three months.You have upper limb pain or injury that makes it hard for you to do aerobic exercise.You use a manual wheelchair as your main way to get around for at least 30 hours per week.Control participants have had lower body injuries that haven't fully healed.You have a severe spinal cord injury categorized as A, B, or C by the American Spinal Injury Association Impairment Scale.You have had an allergic reaction to lidocaine in the past.Control participants should not have a history of conditions that could affect how their muscles work.You have had an allergic reaction to lidocaine in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Individuals with SCI
- Group 2: Controls (No SCI)
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 still opportunities for individuals to participate in this clinical trial?
"According to clinicaltrials.gov, this medical trial is not calling for new participants at the moment. Initially published on November 21st 2022 and most recently modified on October 14th 2022, it does not appear that this research study is recruiting volunteers currently - although there are 904 other studies seeking enrolment presently."
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