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OpenTrials
Completed

NCT Number: NCT05376449

Spinal Cord Injury - Exercise

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Effect of Exercise on Inflammation (C-reactive Protein)

    Time frame: 12 weeks

    Change in C-reactive protein after 12 week exercise program

  2. Effect of Exercise on Inflammation (Interleukin 6)

    Time frame: 12 weeks

    Change in Interleukin 6 after 12 week exercise program

  3. Effect of Exercise on Inflammation (Tumor Necrosis)

    Time frame: 12 weeks

    Change in Tumor Necrosis Biomarker after 12 week exercise program

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 17, 2022
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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