Exercise Guidelines for Spinal Cord Injury

Overseen By Femke Hoekstra, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Non-MSK pain, Insufficient arm function, Cognitive impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercise can reduce chronic pain in adults with spinal cord injuries. The goal is to determine if a personalized exercise plan, followed at home or in the community, can effectively manage pain that often surpasses the injury in severity. Participants will either begin a specific exercise routine immediately or wait six months to start. The study seeks adults with spinal cord injuries who experience ongoing pain and currently engage in less than 40 minutes of structured exercise per week. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance pain management strategies for spinal cord injury patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that exercise might safely help manage chronic pain in people with spinal cord injuries (SCI). Studies have found that exercise can improve fitness and heart health without causing serious side effects. For example, following an exercise plan like cycling or strength training can help reduce muscle loss and increase overall body strength.

Other research suggests that people with SCI generally tolerate regular physical activity well. While this trial focuses on exercise guidelines, these guidelines are based on previous studies that have shown positive results. Exercise is usually safe and offers many health benefits, making it a promising option for managing chronic pain from SCI. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores personalized exercise guidelines specifically tailored for individuals with spinal cord injuries. Unlike conventional rehabilitation programs, this approach uses a structured exercise regimen based on international guidelines, gradually increasing in intensity and supported by professionals with specialized training. The trial aims to uncover the benefits of a consistent, progressive exercise plan on physical health and overall quality of life for those with spinal cord injuries, which could offer an innovative and accessible way to enhance their well-being.

What evidence suggests that exercise is effective for reducing chronic pain in adults with spinal cord injury?

Research shows that exercise can help manage chronic pain for people with spinal cord injuries (SCI). Studies have found that high-intensity treadmill training improves muscle coordination, which might help reduce pain. Exercise also increases strength, although it doesn't significantly change psychological outcomes. In this trial, participants in the Exercise Condition arm will follow a personalized exercise prescription based on the International Scientific SCI Exercise Guidelines, which includes moderate-to-vigorous aerobic exercise. These guidelines suggest that such exercise can improve fitness and may also help with pain management. While these findings are encouraging, researchers are still determining the specific type and amount of exercise needed for pain relief in SCI. ^{1 3 4 6 7}

Who Is on the Research Team?

Kathleen Martin Ginis, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

Adults over 18 with spinal cord injury (SCI), experiencing chronic pain for more than 3 months, and doing less than the recommended levels of exercise can join. They must be able to perform a maximal exercise test and have access to a phone. Those with recent injuries (<12 months) or medical conditions that make exercising unsafe cannot participate.

Inclusion Criteria

You are physically able to do a very strenuous exercise test.

My pain from spinal cord injury is either nerve or muscle related.

You don't currently do enough exercise, as defined by specific guidelines, so the trial can see how increasing exercise to recommended levels affects you.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in home-/community-based exercise prescribed according to the SCI exercise guidelines for 6 months

24 weeks

Weekly check-ins with fitness trainer and exercise counselor

Follow-up

Participants are monitored for changes in chronic pain, inflammation, and well-being after the treatment phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The trial is testing if following new SCI exercise guidelines in a home/community setting can significantly reduce chronic pain in adults with SCI. Participants will either follow these exercise recommendations or be part of a control group, to see which method is more effective at managing pain.

How Is the Trial Designed?

Group I: Exercise Condition Experimental Treatment 1 Intervention

The intervention is a personalized exercise prescription based on the International Scientific Spinal Cord Injury (SCI) Exercise Guidelines. Participants begin at the Starting Level guideline: 20 min aerobic exercise, 2x/wk, at 70% of heart rate reserve (or a Borg Continuous Ratio 0-10 rating of 6), \& 3 sets of 10 repetitions of strengthening exercises (each major functioning muscle group at 50-80% of 1-rep max), 2x/wk. Participants will gradually increase aerobic exercise to 30 min, 3x/wk (i.e. the Advanced Level guideline). Exercise implementation will be supported by a fitness trainer and an exercise counsellor with SCI-specific training and experience.

Group II: Wait-list Control Active Control 1 Intervention

Control participants will not get an exercise prescription. They will be asked to refrain from lifestyle changes for 6 mos. After the 6-month waitlist period, Controls will receive the same resources as Exercisers.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10517363/

Effectiveness of the “Evidence-Based Scientific Exercise ... Implementing FES cycle ergometry in the first 6 months of injury may reduce the risk of muscle atrophy and increase LBM. Progressive strength training for up to ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999325007993

Effectiveness of the ProACTIVE SCI intervention on ... There were no statistically significant changes in psychosocial outcomes; however, there were moderate-sized effects for increased strength- ...

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

Effect of high-intensity exercise training on functional ... Furthermore, high-intensity treadmill training has been shown to enhance neuromuscular synergy in individuals with SCI, thereby improving muscle ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10712898/

Exercise and aerobic capacity in individuals with spinal cord ... ‐ The current SCI-specific exercise guidelines encourage moderate-to-vigorous intensity aerobic exercise 40 min per week for fitness benefits or 90 min per week ...

5. nature.com nature.com/articles/s41598-022-07927-5

A national survey of physical activity after spinal cord injury The odds of physical activity in people with SCI were 0.43 (95% CI 0.3–0.61), 0.53 (95% CI 0.36–0.75), and 0.42 (95% CI 0.28–0.61), across the ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2590109525000709

Interim Analysis of the Spinal Cord Injury Program ... Preliminary outcomes included changes in physical activity (Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury) ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04007445

NCT04007445 | Exercise for People with Spinal Cord Injury People with spinal cord injuries (SCI) are at a greater risk for major health conditions and poorer health outcomes than the population without disabilities ...