Spinal Cord Injury - Exercise

The Effect of an Adaptive Exercise Program on Chronic Inflammation in Spinal Cord Injury

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Behavioral: HealthPartners NeuroWell Exercise Program

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55130
      • HealthPartners Neuroscience Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate start; Intervention to start immediately after first visits.	Behavioral: HealthPartners NeuroWell Exercise Program; A 12-week exercise program geared towards individuals with neurological disorders or injuries run by the Regions Hospital Rehabilitation department at the HealthPartners Neuroscience Center. The exercise programming will be designed by the exercise physiologists and adapted to individuals' abilities. Exercise prescriptions will be designed based on established guidelines, level and completeness of injury, individual functional ability, individual goals, and baseline exercise assessments. Program will consist of strength and endurance adaptive exercise.
Active Comparator: Delayed start; Intervention to start after 12 weeks delay.	Behavioral: HealthPartners NeuroWell Exercise Program; A 12-week exercise program geared towards individuals with neurological disorders or injuries run by the Regions Hospital Rehabilitation department at the HealthPartners Neuroscience Center. The exercise programming will be designed by the exercise physiologists and adapted to individuals' abilities. Exercise prescriptions will be designed based on established guidelines, level and completeness of injury, individual functional ability, individual goals, and baseline exercise assessments. Program will consist of strength and endurance adaptive exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Exercise on Inflammation (C-reactive Protein)	Change in C-reactive protein after 12 week exercise program	12 weeks
Effect of Exercise on Inflammation (Interleukin 6)	Change in Interleukin 6 after 12 week exercise program	12 weeks
Effect of Exercise on Inflammation (Tumor Necrosis)	Change in Tumor Necrosis Biomarker after 12 week exercise program	12 weeks

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Investigators: Principal Investigator: Amanda A Herrmann, PhD, HealthPartners Neuroscience Research

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): September 13, 2024

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: A21-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No