Acute Exercise for Spinal Cord Injury

(IBSCI Trial)

Overseen By Nicholas J Gatto, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Parathyroid hormone, Steroids, Bisphosphonates, Glucocorticoids

Disqualifiers: Fractures, Coronary artery disease, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise affects bone health and a protein called irisin in people with spinal cord injuries. Researchers aim to determine if exercise can boost irisin levels and improve bone health. Participants will engage in high-intensity interval exercises using an arm ergometer (a type of exercise bike for the arms), with blood tests conducted before and after to measure changes. Individuals with a spinal cord injury at the neck level or below, who regularly use a manual wheelchair and can perform arm exercises, might be suitable candidates. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could enhance the quality of life for those with spinal cord injuries.

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.

What prior data suggests that this exercise is safe for individuals with spinal cord injury?

Research has shown that high-intensity interval training (HIIT) is generally safe for people with spinal cord injuries (SCI). One study found that people with SCI enjoyed HIIT more than moderate exercise, suggesting it is not only safe but also enjoyable. Another study recommended moderate-to-vigorous aerobic activity for fitness benefits in people with SCI.

Overall, the evidence suggests that HIIT is a safe and effective exercise method for people with SCI. It can improve fitness without causing major problems. While all exercise carries some risks, these studies indicate that HIIT is a good choice for those looking to improve their health after a spinal cord injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using acute exercise for spinal cord injury (SCI) because it offers a novel approach to improving recovery that differs from the standard care options, which often focus on medication and physical rehabilitation. This treatment involves high-intensity interval exercise using an arm ergometer, which may enhance blood flow and muscle activation in a targeted way, potentially leading to better outcomes for individuals with SCI. By focusing on exercise as an immediate intervention, researchers hope to uncover benefits that standard therapies may not address, such as improved bone density and muscle health, which are crucial for SCI recovery.

What evidence suggests that acute exercise is effective for improving bone health in individuals with spinal cord injury?

Research has shown that high-intensity interval training (HIIT) can improve health in individuals with spinal cord injuries in several ways. Studies have found that HIIT enhances insulin use, increases fitness levels, and strengthens muscles. These exercises can also improve cholesterol levels, which are important for heart health. While most research has focused on long-term exercise programs, this trial explores how short bursts of exercise might increase irisin levels, a hormone related to bone health. Participants in this trial, both those with spinal cord injuries and controls without, will undergo high-intensity interval exercise to assess its impact on irisin levels. Early findings suggest that exercise might affect irisin and, in turn, bone health, but more research is needed to confirm this. ^{2 4 5 6 7}

Who Is on the Research Team?

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.

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

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?

Group I: Individuals with SCI Active Control 1 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 Control 1 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.

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving nine male participants with spinal cord injuries, combined arm and leg exercise (HYBRID) resulted in significantly higher oxygen uptake (V˙O2peak) and cardiovascular responses compared to arm cycling alone (ACE) and FES-assisted leg cycling (FES-LCE).

FES-LCE alone produced lower oxygen uptake and cardiovascular metrics, indicating it may not be sufficient for improving aerobic fitness in individuals with spinal cord injuries, suggesting that incorporating combined exercises could enhance fitness outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise responses during functional electrical stimulation cycling in individuals with spinal cord injury. Hasnan, N., Ektas, N., Tanhoffer, AI., et al.[2013]

Circuit resistance training (CRT) and high-intensity interval training (HIIT) can significantly improve cardiorespiratory fitness, muscular strength, and blood lipid levels in individuals with spinal cord injury (SCI), highlighting the importance of exercise for metabolic health in this population.

Using virtual platforms to deliver high-intensity exercise can help overcome barriers such as transportation and facility access, making it easier for individuals with SCI to engage in effective exercise programs while ensuring safety and risk mitigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Strategies for the Broad Delivery of High Intensity Exercise in Persons With Spinal Cord Injury: Ongoing Studies and Considerations for Implementation. McMillan, DW., Astorino, TA., Correa, MA., et al.[2021]

A systematic review of 38 studies involving exercise in adults with spinal cord injury found no serious adverse events (AEs) associated with cardiovascular exercise, suggesting it is safe when following guidelines.

The only notable AEs were musculoskeletal issues related to functional electrical stimulation (FES) walking, while volitional exercise showed very few AEs, indicating that exercise can be beneficial for individuals with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review. Warms, CA., Backus, D., Rajan, S., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Within-session responses to high-intensity interval training in spinal cord injury. Astorino, TA., Thum, JS.[2022]

Hybrid High-Intensity Interval Training (HIIT) using Functional Electrical Stimulation (FES) was found to be safe and well-accepted by participants with spinal cord injuries, with no serious adverse events reported during the 8-week study involving 8 participants.

Participants experienced a significant 17% increase in peak oxygen uptake (VO2peak) and reported improvements in leisure time physical activity and quality of life, indicating that this training method can enhance physical fitness and overall well-being for individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid high-intensity interval training using functional electrical stimulation leg cycling and arm ski ergometer for people with spinal cord injuries: a feasibility study. Vestergaard, M., Jensen, K., Juul-Kristensen, B.[2022]

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Both conditions led to improvements in insulin sensitivity, aerobic capacity, muscle strength, and lipids in patients with spinal cord injury.

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