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Clinical Trials/NCT05376449
NCT05376449
Completed
Not Applicable

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

HealthPartners Institute1 site in 1 country24 target enrollmentMay 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
HealthPartners Institute
Enrollment
24
Locations
1
Primary Endpoint
Effect of Exercise on Inflammation (C-reactive Protein)
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2022
End Date
September 13, 2024
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Effect of Exercise on Inflammation (C-reactive Protein)

Time Frame: 12 weeks

Change in C-reactive protein after 12 week exercise program

Effect of Exercise on Inflammation (Interleukin 6)

Time Frame: 12 weeks

Change in Interleukin 6 after 12 week exercise program

Effect of Exercise on Inflammation (Tumor Necrosis)

Time Frame: 12 weeks

Change in Tumor Necrosis Biomarker after 12 week exercise program

Study Sites (1)

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