Spinal Cord Injuries
Conditions
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.
Interventions
BEHAVIORALHealthPartners 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.
Sponsors
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Exercise on Inflammation (C-reactive Protein) | 12 weeks | Change in C-reactive protein after 12 week exercise program |
| Effect of Exercise on Inflammation (Interleukin 6) | 12 weeks | Change in Interleukin 6 after 12 week exercise program |
| Effect of Exercise on Inflammation (Tumor Necrosis) | 12 weeks | Change in Tumor Necrosis Biomarker after 12 week exercise program |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Start Intervention to start immediately after first visits.
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. | 12 |
| Delayed Start Intervention to start after 12 weeks delay.
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. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Total | Delayed Start | Immediate Start |
|---|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 13 | 49 years STANDARD_DEVIATION 14 | 57 years STANDARD_DEVIATION 11 |
| Ambulation Ambulatory, Manual, and Power Wheelchairs | 2 Participants | 0 Participants | 2 Participants |
| Ambulation Ambulatory & Manual Wheelchair | 4 Participants | 1 Participants | 3 Participants |
| Ambulation Ambulatory Only | 6 Participants | 3 Participants | 3 Participants |
| Ambulation Manual and Power Wheelchairs | 6 Participants | 4 Participants | 2 Participants |
| Ambulation Manual Wheelchair Only | 3 Participants | 3 Participants | 0 Participants |
| Ambulation Power Wheelchair Only | 3 Participants | 1 Participants | 2 Participants |
| American Spinal Injury Association (ASIA) A | 6 Participants | 5 Participants | 1 Participants |
| American Spinal Injury Association (ASIA) B | 0 Participants | 0 Participants | 0 Participants |
| American Spinal Injury Association (ASIA) C | 6 Participants | 2 Participants | 4 Participants |
| American Spinal Injury Association (ASIA) D | 7 Participants | 3 Participants | 4 Participants |
| American Spinal Injury Association (ASIA) E | 0 Participants | 0 Participants | 0 Participants |
| American Spinal Injury Association (ASIA) Unknown | 5 Participants | 2 Participants | 3 Participants |
| Body Mass Index (BMI) | 28 kg per square meter STANDARD_DEVIATION 6 | 29 kg per square meter STANDARD_DEVIATION 7 | 27 kg per square meter STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 12 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Neurological Level of Injury C1-C8 | 13 Participants | 3 Participants | 10 Participants |
| Neurological Level of Injury L1-L5 | 0 Participants | 0 Participants | 0 Participants |
| Neurological Level of Injury S1-S5 | 0 Participants | 0 Participants | 0 Participants |
| Neurological Level of Injury T1-T12 | 9 Participants | 8 Participants | 1 Participants |
| Neurological Level of Injury Unknown | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race (NIH/OMB) Some Other Race | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race (NIH/OMB) White | 19 Participants | 9 Participants | 10 Participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 17 Participants | 7 Participants | 10 Participants |
| Time Since Injury | 10 months STANDARD_DEVIATION 12 | 13 months STANDARD_DEVIATION 15 | 7 months STANDARD_DEVIATION 8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 9 | 0 / 12 | 0 / 8 |
| other Total, other adverse events | 9 / 12 | 2 / 9 | 4 / 12 | 5 / 8 |
| serious Total, serious adverse events | 2 / 12 | 0 / 9 | 3 / 12 | 2 / 8 |
Outcome results
Primary
Effect of Exercise on Inflammation (C-reactive Protein)
Change in C-reactive protein after 12 week exercise program
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Immediate Start | Effect of Exercise on Inflammation (C-reactive Protein) | 0.00 mg/dL |
| Delayed Start | Effect of Exercise on Inflammation (C-reactive Protein) | 0.05 mg/dL |
Primary
Effect of Exercise on Inflammation (Interleukin 6)
Change in Interleukin 6 after 12 week exercise program
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Immediate Start | Effect of Exercise on Inflammation (Interleukin 6) | -0.33 pg/mL |
| Delayed Start | Effect of Exercise on Inflammation (Interleukin 6) | 0.50 pg/mL |
Primary
Effect of Exercise on Inflammation (Tumor Necrosis)
Change in Tumor Necrosis Biomarker after 12 week exercise program
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Immediate Start | Effect of Exercise on Inflammation (Tumor Necrosis) | -2 pg/mL |
| Delayed Start | Effect of Exercise on Inflammation (Tumor Necrosis) | 2 pg/mL |