Back to resultsSpinal Cord Injury - Exercise
Primary Purpose
Spinal Cord Injuries
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HealthPartners NeuroWell Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
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
Sites / Locations
- HealthPartners Neuroscience Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate start
Delayed start
Arm Description
Intervention to start immediately after first visits.
Intervention to start after 12 weeks delay.
Outcomes
Primary Outcome Measures
Effect of exercise on inflammation (C-reactive protein)
Change in C-reactive protein after 12 week exercise program
Effect of exercise on inflammation (Interleukin 6)
Change in Interleukin 6 after 12 week exercise program
Effect of exercise on inflammation (Tumor Necrosis)
Change in Tumor Necrosis Biomarker after 12 week exercise program
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05376449
Brief Title
Spinal Cord Injury - Exercise
Official Title
The Effect of an Adaptive Exercise Program on Chronic Inflammation in Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate start
Arm Type
Experimental
Arm Description
Intervention to start immediately after first visits.
Arm Title
Delayed start
Arm Type
Active Comparator
Arm Description
Intervention to start after 12 weeks delay.
Intervention Type
Behavioral
Intervention Name(s)
HealthPartners NeuroWell Exercise Program
Intervention Description
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 Outcome Measure Information:
Title
Effect of exercise on inflammation (C-reactive protein)
Description
Change in C-reactive protein after 12 week exercise program
Time Frame
12 weeks
Title
Effect of exercise on inflammation (Interleukin 6)
Description
Change in Interleukin 6 after 12 week exercise program
Time Frame
12 weeks
Title
Effect of exercise on inflammation (Tumor Necrosis)
Description
Change in Tumor Necrosis Biomarker after 12 week exercise program
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda A Herrmann, PhD
Organizational Affiliation
HealthPartners Neuroscience Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Neuroscience Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Spinal Cord Injury - Exercise
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