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

11 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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. ^{1 2 3 4 6}

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

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Intervention Design of High-Intensity Interval Training in Individuals With Spinal Cord Injury: Narrative Review and Future Perspectives. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Within-session responses to high-intensity interval training in spinal cord injury. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Overview of Systematic Reviews of Aerobic Fitness and Muscle Strength Training after Spinal Cord Injury. [2020]

4. Switzerland 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. [2021]

5. England 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Exercise responses during functional electrical stimulation cycling in individuals with spinal cord injury. [2013]