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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
No Placebo-Only Group

Summary

This trial examines how a muscle-released protein called irisin affects bone health in people with spinal cord injuries. Irisin is released by muscle during physical activity and has been studied for its potential role in bone and muscle health. It targets individuals with spinal cord injuries who suffer from severe bone loss and ineffective current treatments. The study tests if arm exercises can increase irisin levels and improve bone health.

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and immediately post-exercise
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and immediately post-exercise for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Exercise induced change in irisin concentration
FNDC5 gene expression
Irisin - Bone measure correlations

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Exercise regimens that increase circulating irisin are particularly beneficial for Spinal Cord Injury (SCI) patients. Irisin, a myokine released during physical activity, has been shown to improve bone health and muscle function, which are critical areas of concern for SCI patients who often experience muscle atrophy and bone density loss due to reduced mobility. By increasing irisin levels through targeted exercise, SCI patients can potentially mitigate these complications, improve overall physical function, enhance cardiovascular health, and boost mental well-being, making exercise a comprehensive treatment strategy.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,604 Total Patients Enrolled
Adam J. Sterczala, PhDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Media Library

Individuals with SCI Clinical Trial Eligibility Overview. Trial Name: NCT05319522 — N/A
Spinal Cord Injury Research Study Groups: Individuals with SCI, Controls (No SCI)
Spinal Cord Injury Clinical Trial 2023: Individuals with SCI Highlights & Side Effects. Trial Name: NCT05319522 — N/A
Individuals with SCI 2023 Treatment Timeline for Medical Study. Trial Name: NCT05319522 — N/A
~10 spots leftby Apr 2025