Spinal Cord Injury - Exercise

NCT05376449 | Completed Results

• 1 other identifier: A21-009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Immediate start

EXPERIMENTAL

Intervention to start immediately after first visits.

Behavioral: HealthPartners NeuroWell Exercise Program

Delayed start

ACTIVE COMPARATOR

Intervention to start after 12 weeks delay.

Behavioral: HealthPartners NeuroWell Exercise Program

Interventions

HealthPartners NeuroWell Exercise Program BEHAVIORAL

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.

Delayed start; Immediate start

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Amanda Herrmann, PhD
• Organization: HealthPartners Institute Neuroscience Research Center

Amanda.A.Herrmann@HealthPartners.com

651-495-6363

Study Officials

• Amanda A Herrmann, PhD

  HealthPartners Neuroscience Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: May 9, 2022
• Primary Completion: June 20, 2024
• Study Completion: September 13, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)