Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate start | Experimental | Intervention to start immediately after first visits. |
|
| Delayed start | Active Comparator | Intervention to start after 12 weeks delay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HealthPartners NeuroWell Exercise Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Exercise on Inflammation (C-reactive Protein) | Change in C-reactive protein after 12 week exercise program | 12 weeks |
| Effect of Exercise on Inflammation (Interleukin 6) | Change in Interleukin 6 after 12 week exercise program | 12 weeks |
| Effect of Exercise on Inflammation (Tumor Necrosis) | Change in Tumor Necrosis Biomarker after 12 week exercise program | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amanda A Herrmann, PhD | HealthPartners Neuroscience Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Weeks 1-12 |
| |||||||||||||
| Weeks 13-24 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of Exercise on Inflammation (C-reactive Protein) | Change in C-reactive protein after 12 week exercise program | Posted | Mean | Inter-Quartile Range | mg/dL | 12 weeks |
|
24 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Start - Exercise Program | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute intracranial hemorrage | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Herrmann, PhD | HealthPartners Institute Neuroscience Research Center | 651-495-6363 | Amanda.A.Herrmann@HealthPartners.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2023 | Sep 2, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| American Spinal Injury Association (ASIA) | ASIA Impairment Scale A - Complete Injury B - Sensory Incomplete C - Motor Incomplete (Limited Movement) D - Motor Incomplete (Functional Movement) E - Normal Function | Count of Participants | Participants |
|
| Neurological Level of Injury | Neurological injury level describes the specific location where the spinal cord is damaged. C1-C8: Cervical T1-T12: Thoracic L1-L5: Lumbar S1-S5: Sacrum | Count of Participants | Participants |
|
| Time Since Injury | Mean | Standard Deviation | months |
|
| Ambulation | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg per square meter |
|
| OG001 |
| 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. |
|
|
| Primary | Effect of Exercise on Inflammation (Interleukin 6) | Change in Interleukin 6 after 12 week exercise program | Posted | Mean | Inter-Quartile Range | pg/mL | 12 weeks |
|
|
|
| Primary | Effect of Exercise on Inflammation (Tumor Necrosis) | Change in Tumor Necrosis Biomarker after 12 week exercise program | Posted | Mean | Inter-Quartile Range | pg/mL | 12 weeks |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| 9 |
| 12 |
| EG001 | Immediate Start - No Exercise | Intervention to start immediately after first visits - Delay after program is complete. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG002 | Delayed Start - No Exercise | Intervention to start after 12 weeks delay. | 0 | 12 | 3 | 12 | 4 | 12 |
| EG003 | Delayed Start - Exercise Program | 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. | 0 | 8 | 2 | 8 | 5 | 8 |
| Skin Issues | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Infection around pacemaker |
|
| Lighheaded/Syncope | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Infection | Renal and urinary disorders | Non-systematic Assessment | Catheter-associated urinary tract infection |
|
| Pain | General disorders | Non-systematic Assessment | Headache/Delirium |
|
| Breathing Issues | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Shortness of breath |
|
| Closed displaced fracture of left tibial spine | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Skin Issues | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Breathing Issues | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sleep/mood disturbance | General disorders | Non-systematic Assessment |
|
| Infection | General disorders | Non-systematic Assessment |
|
| Gastrointestinal Issues | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lightheaded/Syncope | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment | Falls, balance instability |
|
Not provided
Not provided
Not provided
| D014947 | Wounds and Injuries |