Adaptive Exercise Program for Spinal Cord Injury

Overseen By Amanda A Herrmann, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Heart failure, Chronic lung disease, Angina, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a 12-week adaptive exercise program, the HealthPartners NeuroWell Exercise Program, can reduce inflammation in people with spinal cord injuries. High inflammation is linked to heart and lung diseases. Participants will either begin the exercise program immediately or after a 12-week delay. The trial seeks individuals who have had a spinal cord injury for at least six months and can move their elbows and wrists sufficiently to participate. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance health outcomes for individuals with spinal cord injuries.

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

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

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

Research shows that exercise programs are generally safe for people with spinal cord injuries. Studies have found that these programs can improve muscle strength and quality of life. No specific reports of serious side effects from exercise in people with neurological disorders exist.

This trial tests a special exercise program designed to reduce inflammation in people with spinal cord injuries. While researchers are still studying this specific program, general evidence suggests that exercise is safe and beneficial. Participants might experience some muscle soreness, common when starting new exercises, but this is usually mild and temporary.

Overall, existing research supports that participating in exercise programs is safe and can positively impact overall health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HealthPartners NeuroWell Exercise Program for spinal cord injury because it offers a new approach to rehabilitation. Unlike traditional physical therapy that often follows a fixed routine, this program is adaptive, meaning it tailors exercises to the individual's progress and specific needs. This personalization could potentially lead to better outcomes by engaging patients more effectively and addressing their unique recovery challenges. Additionally, the program's flexible start times, with immediate and delayed options, allow researchers to explore the impact of timing on rehabilitation success, which could inform future treatment protocols.

What evidence suggests that this exercise program is effective for reducing inflammation in people with spinal cord injury?

Research has shown that exercise can help lower inflammation, which tends to be higher in people with spinal cord injuries (SCI) than in those without. This inflammation links to serious health issues like heart and lung diseases. In this trial, participants will join the HealthPartners NeuroWell Exercise Program, which aims to reduce these inflammation levels. Some participants will start the program immediately, while others will begin after a 12-week delay. Studies have demonstrated that exercise can decrease inflammation and improve overall health, especially for people who are usually inactive. Although specific data on this exact program is limited, research strongly supports the benefits of exercise for reducing inflammation. ^{1 3 4 5 6}

Who Is on the Research Team?

Amanda A Herrmann, PhD

Principal Investigator

HealthPartners Neuroscience Research

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with spinal cord injury (SCI) who are at least 6 months post-injury, can move their elbows, wrists, and shoulders enough to do the exercises, and can consent. It's not for non-English speakers, those with conditions limiting exercise like heart failure or severe spasms, pregnant individuals, or anyone in another study recently.

Inclusion Criteria

Ability to provide and provision of signed and dated informed consent form

I can move my elbow, wrist, and shoulder well enough to do study tasks.

I have been diagnosed with a spinal cord injury for over 6 months.

Exclusion Criteria

I do not have any cognitive issues that prevent me from participating.

I need a machine to help me breathe.

My spasms prevent me from joining in study activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week adaptive exercise program to reduce inflammation

12 weeks

Follow-up

Participants are monitored for changes in inflammation markers after the exercise program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HealthPartners NeuroWell Exercise Program

Trial Overview

The HealthPartners NeuroWell Exercise Program is being tested to see if it reduces inflammation in people with SCI. Participants will be randomly assigned to either start a 12-week adaptive exercise program immediately or after a delay of the same duration.

How Is the Trial Designed?

Group I: Immediate start Experimental Treatment 1 Intervention

Intervention to start immediately after first visits.

Group II: Delayed start Active Control 1 Intervention

Intervention to start after 12 weeks delay.

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05376449

Study Details | NCT05376449 | Spinal Cord Injury - Exercise

A 12-week exercise program geared towards individuals with neurological disorders or injuries run by the Regions Hospital Rehabilitation department at the ...

2.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/49/NCT05376449/Prot_SAP_000.pdf

The Effect of an Adaptive Exercise Program on Chronic ...

Individuals with SCI have been reported to have higher levels of inflammation when compared to healthy individuals.

3.

healthpartners.com

healthpartners.com/institute/research/studies/category/neuroscience/

Neuroscience - HealthPartners Institute

The purpose of this study is to test the difference between light and moderate intensity exercise on health outcomes in people with MG.

4.

healthpartners.com

healthpartners.com/content/dam/brand-identity/pdfs/corporate/Rehabilitation-Center-AnnualReport-2017-Final.pdf

Regions Hospital Rehabilitation Center 2017 Annual Report

FUNCTIONAL OUTCOMES. FOR PATIENTS WITH. NON-TRAUMATIC. SPINAL CORD INJURY. Our number of patients with a non-traumatic spinal cord injury declined. Functional ...

5.

withpower.com

withpower.com/trial/adaptive-exercise-program-for-spinal-cord-injury-b0cbc

Adaptive Exercise Program for Spinal Cord Injury

Trial Overview The HealthPartners NeuroWell Exercise Program is being tested to see if it reduces inflammation in people with SCI. Participants will be randomly ...

6.

healthpartners.com

healthpartners.com/content/dam/brand-identity/pdfs/corporate/2020-regions-rehab-center-annual-report.pdf

REHABILITATION CENTER

Our patients with major multiple trauma and brain or spinal cord injury made greater overall functional gains over a significantly shorter length of stay ...