N/A
N=24
Spinal Cord Injury - Exercise
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT05376449 ↗Enrolled (actual)
24
Serious AEs
17.1%
Results posted
Oct 2025
Primary outcome: Primary: Effect of Exercise on Inflammation (C-reactive Protein) — 0.00; 0.05 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HealthPartners NeuroWell Exercise Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Exercise on Inflammation (C-reactive Protein) |
0.00; 0.05 | — |
| PRIMARY Effect of Exercise on Inflammation (Interleukin 6) |
-0.33; 0.50 | — |
| PRIMARY Effect of Exercise on Inflammation (Tumor Necrosis) |
-2; 2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Ability to provide and provision of signed and dated informed consent form
- Age 18-70
- Diagnosis of SCI and post injury ≥ 6 months
- 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
Exclusion Criteria
- Non-English speaking
- Exercise program participation ≤1 month from study enrollment or any other exercise participation during the duration of the study
- Patients with significant cognitive impairment of any etiology that prevents them from being able to participate
- Patients that were given sternal or spinal precautions that would prevent excessive twisting, bending, overhead reaching and lifting over 10 pounds
- Patients with a history heart failure, chronic lung disease, angina or any other condition that causes unreasonable shortness of breath on exertion
- Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled
- Requires ventilator support
- Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator
- Pregnant, planning to become pregnant
- Any other medical conditions that could affect their ability to participate in the exercise program (as determined by study investigators)
- Active participation or past participation ≤3 months in any other interventional study.
- Unwilling to participate in all study related activities
Data sourced from ClinicalTrials.gov (NCT05376449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.