Spinal Cord Injury - Exercise

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Behavioral: HealthPartners NeuroWell Exercise Program

• Registration Number: NCT05376449
• Lead Sponsor: HealthPartners Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-09
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-17
• Primary Completion: 2024-06-20
• Study Completion: 2024-09-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed start	HealthPartners NeuroWell Exercise Program	Intervention to start after 12 weeks delay.
Immediate start	HealthPartners NeuroWell Exercise Program	Intervention to start immediately after first visits.

Primary Outcome Measures

Name	Time	Method
Effect of exercise on inflammation (C-reactive protein)	12 weeks	Change in C-reactive protein after 12 week exercise program
Effect of exercise on inflammation (Interleukin 6)	12 weeks	Change in Interleukin 6 after 12 week exercise program
Effect of exercise on inflammation (Tumor Necrosis)	12 weeks	Change in Tumor Necrosis Biomarker after 12 week exercise program

Trial Locations

Locations (1)

HealthPartners Neuroscience Center; 🇺🇸 Saint Paul, Minnesota, United States