Clinical trial NCT05376449: Spinal Cord Injury - Exercise
Official title: The Effect of an Adaptive Exercise Program on Chronic Inflammation in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)
* Active participation or past participation ≤3 months in any other interventional study.
* Unwilling to participate in all study related activities

Primary outcomes:
measure: Effect of exercise on inflammation (C-reactive protein)
timeFrame: 12 weeks
measure: Effect of exercise on inflammation (Interleukin 6)
timeFrame: 12 weeks
measure: Effect of exercise on inflammation (Tumor Necrosis)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Neuroscience Research
name: Amanda A Herrmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: