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Adaptive Exercise Program for Spinal Cord Injury

N/A

Waitlist Available

Led By Amanda A Herrmann, PhD

Research Sponsored by HealthPartners Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to achieve adequate active range of motion at the elbow and wrist (flexion/extension) and able to achieve at least 90° active shoulder flexion, in order to complete study activities

Age 18-70

Must not have

Patients with significant cognitive impairment of any etiology that prevents them from being able to participate

Requires ventilator support

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Summary

This trial will test whether a 12-week adaptive exercise program can reduce inflammation in people with SCI, who are often inactive.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves an exercise program designed for individuals with SCI, side effects may include muscle soreness or fatigue. However, participants with conditions that could worsen due to exercise have been excluded from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I need a machine to help me breathe.

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I do not speak English.

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I have been advised not to twist, bend excessively, reach overhead, or lift over 10 pounds.

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I have severe and uncontrolled autonomic dysreflexia.

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I have a condition like heart failure or lung disease that makes me unusually short of breath.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effect of exercise on inflammation (C-reactive protein)

Effect of exercise on inflammation (Interleukin 6)

Effect of exercise on inflammation (Tumor Necrosis)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate startExperimental Treatment1 Intervention

Intervention to start immediately after first visits.

Group II: Delayed startActive Control1 Intervention

Intervention to start after 12 weeks delay.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

HealthPartners InstituteLead Sponsor

191 Previous Clinical Trials

3,721,633 Total Patients Enrolled

Amanda A Herrmann, PhDPrincipal InvestigatorHealthPartners Neuroscience Research

2 Previous Clinical Trials

63 Total Patients Enrolled

Media Library

HealthPartners NeuroWell Exercise Program Clinical Trial Eligibility Overview. Trial Name: NCT05376449 — N/A

Spinal Cord Injury Research Study Groups: Immediate start, Delayed start

Spinal Cord Injury Clinical Trial 2023: HealthPartners NeuroWell Exercise Program Highlights & Side Effects. Trial Name: NCT05376449 — N/A

HealthPartners NeuroWell Exercise Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05376449 — N/A

~0 spots leftby Oct 2024

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