Clincosm LogoSign in Get a demo

Spinal Cord Injury - Exercise

Sponsor
HealthPartners Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05376449
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
24.8
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HealthPartners NeuroWell Exercise Program
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of an Adaptive Exercise Program on Chronic Inflammation in Spinal Cord Injury
Actual Study Start Date :
May 9, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immediate start

Intervention to start immediately after first visits.

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.
Active Comparator: Delayed start

Intervention to start after 12 weeks delay.

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.

Outcome Measures

Primary Outcome Measures

  1. Effect of exercise on inflammation (C-reactive protein) [12 weeks]

    Change in C-reactive protein after 12 week exercise program

  2. Effect of exercise on inflammation (Interleukin 6) [12 weeks]

    Change in Interleukin 6 after 12 week exercise program

  3. Effect of exercise on inflammation (Tumor Necrosis) [12 weeks]

    Change in Tumor Necrosis Biomarker after 12 week exercise program

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 HealthPartners Neuroscience Center Saint Paul Minnesota United States 55130

Sponsors and Collaborators

  • HealthPartners Institute

Investigators

  • Principal Investigator: Amanda A Herrmann, PhD, HealthPartners Neuroscience Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT05376449
Other Study ID Numbers:
  • A21-009
First Posted:
May 17, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries

Study Results

No Results Posted as of Jun 21, 2022