High-Intensity Exercise for Spinal Cord Injury

Overseen By Thomas G Hornby, PT, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Intrathecal baclofen, Botulinum toxin

Disqualifiers: Obesity, Cardiovascular disease, Orthopedic bracing, others

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

Compensation: Varies

Number of Visits: 30

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how high-intensity walking exercises can improve mobility for people with chronic, motor incomplete spinal cord injuries. It compares the effectiveness of high-intensity walking sessions to lower-intensity ones. Participants must have had a spinal cord injury for over a year and be able to walk with little or no help. The study aims to determine if more intense exercise can improve walking abilities and overall health. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance rehabilitation strategies for spinal cord injuries.

Do I need to stop taking my current medications for the trial?

The trial does not require you to stop taking your current medications, especially if you are on oral anti-spastic medications. However, if you have an intrathecal baclofen pump or have had a recent botulinum toxin injection in the lower extremities, you may be excluded from participating.

What prior data suggests that high-intensity walking training is safe for individuals with spinal cord injury?

Research has shown that high-intensity walking exercises are generally safe for people with partial spinal cord injuries. Studies have found these exercises to be both effective and well-tolerated. Many participants appreciate these programs for their safety, affordability, and ease of practice.

Participants in high-intensity walking exercises reported improved walking abilities. Importantly, these studies reported no major problems or side effects, indicating the exercises' safety.

Some studies use low-intensity walking exercises for comparison. This type of training is also safe and helps improve walking ability.

Overall, both high- and low-intensity walking programs are considered safe for people with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different intensities of walking training can benefit individuals with spinal cord injuries. Unlike standard rehabilitation practices, which often include low-intensity exercises, this study is testing high-intensity locomotor training, aiming to push heart rates to about 80% of one's heart rate reserve. This approach could potentially enhance cardiovascular fitness and muscle strength more effectively. By comparing high and low intensity sessions, researchers hope to find out if pushing the limits safely can lead to better recovery outcomes.

What evidence suggests that this trial's walking training treatments could be effective for spinal cord injury?

This trial will compare High Intensity Locomotor Training with Low Intensity Locomotor Training for individuals with partial spinal cord injuries. Research has shown that high-intensity walking training can improve walking ability. One study found that practicing walking at a high intensity is crucial for enhancing mobility. High-intensity exercise is beneficial because it is cost-effective, safe, and can significantly enhance walking ability. This training often involves walking faster or on varied surfaces to challenge the body, leading to better results. Overall, evidence suggests that engaging in more intense training can be more effective for improving mobility than less intense exercises. ^{1 3 4 6 7}

Who Is on the Research Team?

Thomas G Hornby

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with chronic motor incomplete spinal cord injury (AIS C or D), lasting more than a year, and lesions between C1-T10. They should be able to walk with minimal assistance and have normal range of motion in their legs. Excluded are those over 400 lbs, with certain health issues like unhealed wounds, heart disease, severe osteoporosis, lung diseases, or brain injuries.

Inclusion Criteria

I have a spinal cord injury between C1-T10 and can still move somewhat.

I have a spinal cord injury that is not fully paralyzing, lasting more than a year, between my neck and mid-back.

I can walk and move my ankles, knees, and hips within normal ranges.

Exclusion Criteria

You have a history of autonomic dysreflexia.

You weigh more than 400 pounds.

I am currently receiving physical therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high or low intensity locomotor training for 2 months, consisting of 30 sessions of walking-related activities in variable contexts

8 weeks

30 sessions

Follow-up

Participants are monitored for changes in locomotor performance, cardiopulmonary capacity, and neuromuscular coordination

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Walking training

Trial Overview The study tests the effectiveness of high-intensity walking training versus lower-intensity exercise for people with chronic motor incomplete spinal cord injury. It aims to see which intensity level improves walking ability better.

How Is the Trial Designed?

Group I: High Intensity Locomotor Training Experimental Treatment 1 Intervention

High Intensity Locomotor Training will consist of 30 sessions of walking related activities in variable contexts (i..e, on a treadmill, overground, and on stairs), with a primary goal to achieve 40 minutes of walking within 1 hour sessions while achieving heart rates close to 80% of heart rate reserve.

Group II: Low Intensity Locomotor Training Active Control 1 Intervention

High Intensity Locomotor Training will consist of 30 sessions of walking related activities in variable contexts (i..e, on a treadmill, overground, and on stairs), with a primary goal to achieve 40 minutes of walking within 1 hour sessions while achieving heart rates from 30% to 40% of heart rate reserve.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Rehabilitation Hospital of Indiana

Collaborator

Trials

13

Recruited

5,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5729047/

Effects of training intensity on locomotor performance in ... Previous studies in individuals with other neurologic injuries suggest the intensity of locomotor training (LT) may positively influence walking outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5131185/

Effects of Locomotor Exercise Intensity on Gait Performance in ... High-intensity stepping practice may be a critical component to improve gait following motor incomplete spinal cord injury (iSCI). However, such practice is ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03714997

NCT03714997 | High Intensity Exercise in Incomplete SCI The goal of this study is to identify the comparative efficacy of high-intensity walking training in individuals with chronic, motor incomplete spinal cord ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1442004/full

Effect of high-intensity exercise training on functional ... In recent years, exercise training has gained prominence in the treatment of SCI due to its advantages, including low cost, high safety, ease of ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999320313393

The Value of High Intensity Locomotor Training Applied to ... The purpose of this review is to delineate some of the evidence regarding the effects of exercise intensity during locomotor training in patients with stroke ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8581515/

The Value of High Intensity Locomotor Training Applied to ... A clinical prediction rule for ambulation outcomes after traumatic spinal cord injury: a longitudinal cohort study. Lancet 2011;377:1004–10. [DOI] [PubMed] ...

7. mayoclinic.org mayoclinic.org/tests-procedures/locomotor-training-for-spinal-cord-injury/about/pac-20394608

Locomotor training for spinal cord injury Some studies have found that locomotor training for a spinal cord injury can lead to improvements in function. People with some feeling and ...