Spinal Cord Injury - Exercise

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05376449
• Other study ID #: A21-009
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	HealthPartners Neuroscience Center	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of exercise on inflammation (C-reactive protein)	Change in C-reactive protein after 12 week exercise program	12 weeks
Primary	Effect of exercise on inflammation (Interleukin 6)	Change in Interleukin 6 after 12 week exercise program	12 weeks
Primary	Effect of exercise on inflammation (Tumor Necrosis)	Change in Tumor Necrosis Biomarker after 12 week exercise program	12 weeks