11 Participants Needed

Acute Exercise for Spinal Cord Injury

(IBSCI Trial)

AJ
NJ
Overseen ByNicholas J Gatto, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking medications that affect bone metabolism, like parathyroid hormone, steroids, bisphosphonates, or oral glucocorticoids, you will need to stop them to participate in this study.

Is acute exercise safe for people with spinal cord injuries?

Research on high-intensity interval training (HIIT) for people with spinal cord injuries suggests that while there are safety considerations due to the neurological consequences of the injury, exercise can be beneficial for health. However, specific adverse events have not been fully enumerated, indicating a need for careful monitoring and specialized guidance during exercise.12345

How does acute exercise differ from other treatments for spinal cord injury?

Acute exercise for spinal cord injury is unique because it involves high-intensity interval training (HIIT) and functional electrical stimulation (FES) to improve cardiovascular health and muscle strength. This approach is different from traditional treatments as it combines vigorous exercise with technology to stimulate muscles, which can be delivered virtually to overcome accessibility barriers.12467

What data supports the effectiveness of the treatment Acute Exercise, Acute Aerobic Exercise, High-Intensity Interval Training (HIIT), Short-Duration Exercise for Spinal Cord Injury?

Research suggests that high-intensity interval training (HIIT) can improve cardiovascular health and fitness in people with spinal cord injury, similar to its benefits in the general population. Although evidence quality is low, exercise guidelines recommend moderate to vigorous exercise to enhance aerobic fitness and muscle strength in this group.12346

Who Is on the Research Team?

AJ

Adam J. Sterczala, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have a spinal cord injury at the level of the neck or lower that happened at least 12 months ago.
You need to have enough strength and use of your arms to operate a special bike during the study.
You can move to and from a wheelchair by yourself.
See 3 more

Exclusion Criteria

Control Participants: pregnant
You have a bone-related condition like Paget's disease or a bone disorder related to kidney problems.
Participants with SCI: pregnant
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline blood draw, muscle biopsy, and DXA/HR-pQCT bone imaging

1 week
1 visit (in-person)

Exercise Intervention

Participants undergo arm ergometer high-intensity interval exercise with blood draws before and after exercise

1 week
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after exercise intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acute Exercise
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Individuals with SCIActive Control1 Intervention
Group II: Controls (No SCI)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

High-intensity interval training (HIIT) shows promise for improving cardiovascular health in individuals with spinal cord injury (SCI), but the current research lacks standardized protocols, making it difficult to draw definitive conclusions.
A review of 26 studies highlights the need for more consistent HIIT interventions to better understand their effects on cardiorespiratory fitness and cardiometabolic risk factors in people with SCI.
Intervention Design of High-Intensity Interval Training in Individuals With Spinal Cord Injury: Narrative Review and Future Perspectives.Veith, DD., Linde, MB., Wiggins, CC., et al.[2023]
High-intensity interval training (HIIT) and sprint interval training resulted in higher peak oxygen uptake and heart rates compared to moderate intensity exercise in 9 adults with spinal cord injury, indicating that these interval training methods can effectively enhance cardiorespiratory fitness in this population.
Participants preferred interval training over moderate exercise, suggesting that HIIT may be a more engaging and feasible exercise option for individuals with spinal cord injury, warranting further research into its long-term benefits.
Within-session responses to high-intensity interval training in spinal cord injury.Astorino, TA., Thum, JS.[2022]
This overview of 16 systematic reviews highlights that while the quality of evidence on exercise for improving aerobic fitness and muscle strength in people with spinal cord injury is critically low, it still provides valuable guidelines for effective exercise types and intensities.
Specifically, ergometry training and resistance training, when performed at moderate to vigorous intensity twice weekly for 6 weeks, are suggested to enhance aerobic fitness and muscle strength, respectively.
Overview of Systematic Reviews of Aerobic Fitness and Muscle Strength Training after Spinal Cord Injury.Eitivipart, AC., de Oliveira, CQ., Arora, M., et al.[2020]

Citations

Intervention Design of High-Intensity Interval Training in Individuals With Spinal Cord Injury: Narrative Review and Future Perspectives. [2023]
Within-session responses to high-intensity interval training in spinal cord injury. [2022]
Overview of Systematic Reviews of Aerobic Fitness and Muscle Strength Training after Spinal Cord Injury. [2020]
Virtual Strategies for the Broad Delivery of High Intensity Exercise in Persons With Spinal Cord Injury: Ongoing Studies and Considerations for Implementation. [2021]
Hybrid high-intensity interval training using functional electrical stimulation leg cycling and arm ski ergometer for people with spinal cord injuries: a feasibility study. [2022]
Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review. [2021]
Exercise responses during functional electrical stimulation cycling in individuals with spinal cord injury. [2013]
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