What side effects are associated with this type of intervention?

Exercise regimens for spinal cord injury, aimed at increasing circulating irisin, are generally considered safe and beneficial for improving muscle strength, cardiovascular health, and overall well-being. However, potential side effects can include muscle soreness, fatigue, and the risk of overuse injuries. Other common treatments for SCI include physical therapy, which may cause temporary discomfort or pain, and medications such as pain relievers and muscle relaxants, which can have side effects like drowsiness, dizziness, and gastrointestinal issues. It is important for patients to work closely with their healthcare providers to tailor treatments to their individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting the increase of circulating irisin for Spinal Cord Injury (SCI). Most FDA-approved treatments for SCI focus on managing symptoms and preventing further damage, such as corticosteroids to reduce inflammation. Research is ongoing in various areas, including the potential benefits of exercise regimens, which may increase circulating irisin and improve muscle and bone health in individuals with SCI. However, these exercise-based treatments are still under investigation and have not yet received FDA approval.

What other types of research exist?

Promising novel alternatives to exercise regimens for increasing circulating irisin in spinal cord injury patients include: 1) Pharmacological agents targeting the Rho pathway, such as Cethrin, which have neuroregenerative properties. 2) Stem cell therapies, including the use of mesenchymal stem cells and autologous macrophage implantation, which are being investigated for their potential to promote neural repair and regeneration. 3) Advanced integrative therapies like Scrambler Therapy, which has shown efficacy in managing chronic pain and may have ancillary benefits for neural health.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and immediately post-exercise

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.

Do I qualify?Apply below to find out

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.