Adaptive Exercise Program for Spinal Cord Injury

Recruiting in Saint Paul (>99 mi)

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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

Long lasting inflammation in the body is related to cardiovascular and respiratory disease, which are the two most common causes of death in people living with spinal cord injury (SCI). Individuals with SCI have been reported to have higher levels of inflammation when compared to healthy individuals. Exercise is a well-known method to reduce inflammation; however, people with SCI are often inactive. The main goal of this study is to determine whether a 12-week adaptive exercise program can reduce inflammation in people with SCI. Participants will be randomized to start exercise immediately or after a 12-week delay.

Research Team

Amanda A Herrmann, PhD

Principal Investigator

HealthPartners Neuroscience Research

Eligibility Criteria

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 am between 18 and 70 years old.

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

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

Treatment Details

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.

Participant Groups

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+