Trial Outcomes & Findings for Spinal Cord Injury - Exercise (NCT NCT05376449)
NCT ID: NCT05376449
Last Updated: 2025-10-17
Results Overview
Change in C-reactive protein after 12 week exercise program
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-10-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Weeks 1-12
STARTED
|
12
|
12
|
|
Weeks 1-12
COMPLETED
|
9
|
8
|
|
Weeks 1-12
NOT COMPLETED
|
3
|
4
|
|
Weeks 13-24
STARTED
|
9
|
8
|
|
Weeks 13-24
COMPLETED
|
9
|
5
|
|
Weeks 13-24
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spinal Cord Injury - Exercise
Baseline characteristics by cohort
| Measure |
Immediate Start
n=12 Participants
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.
|
Delayed Start
n=12 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 11 • n=99 Participants
|
49 years
STANDARD_DEVIATION 14 • n=107 Participants
|
53 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · White
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · Some Other Race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA)
A
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA)
B
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA)
C
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA)
D
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA)
E
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
American Spinal Injury Association (ASIA)
Unknown
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Neurological Level of Injury
C1-C8
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Neurological Level of Injury
T1-T12
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Neurological Level of Injury
L1-L5
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Neurological Level of Injury
S1-S5
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Neurological Level of Injury
Unknown
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Time Since Injury
|
7 months
STANDARD_DEVIATION 8 • n=99 Participants
|
13 months
STANDARD_DEVIATION 15 • n=107 Participants
|
10 months
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Ambulation
Ambulatory & Manual Wheelchair
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ambulation
Ambulatory Only
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ambulation
Ambulatory, Manual, and Power Wheelchairs
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ambulation
Manual and Power Wheelchairs
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ambulation
Manual Wheelchair Only
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ambulation
Power Wheelchair Only
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
27 kg per square meter
STANDARD_DEVIATION 5 • n=99 Participants
|
29 kg per square meter
STANDARD_DEVIATION 7 • n=107 Participants
|
28 kg per square meter
STANDARD_DEVIATION 6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksChange in C-reactive protein after 12 week exercise program
Outcome measures
| Measure |
Immediate Start
n=9 Participants
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.
|
Delayed Start
n=8 Participants
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.
|
|---|---|---|
|
Effect of Exercise on Inflammation (C-reactive Protein)
|
0.00 mg/dL
Interval -0.01 to 0.01
|
0.05 mg/dL
Interval 0.0 to 0.55
|
PRIMARY outcome
Timeframe: 12 weeksChange in Interleukin 6 after 12 week exercise program
Outcome measures
| Measure |
Immediate Start
n=8 Participants
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.
|
Delayed Start
n=8 Participants
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.
|
|---|---|---|
|
Effect of Exercise on Inflammation (Interleukin 6)
|
-0.33 pg/mL
Interval -1.28 to -0.18
|
0.50 pg/mL
Interval 0.03 to 1.84
|
PRIMARY outcome
Timeframe: 12 weeksChange in Tumor Necrosis Biomarker after 12 week exercise program
Outcome measures
| Measure |
Immediate Start
n=8 Participants
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.
|
Delayed Start
n=8 Participants
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.
|
|---|---|---|
|
Effect of Exercise on Inflammation (Tumor Necrosis)
|
-2 pg/mL
Interval -3.0 to 6.0
|
2 pg/mL
Interval -2.0 to 5.0
|
Adverse Events
Immediate Start - Exercise Program
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Immediate Start - No Exercise
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Delayed Start - No Exercise
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Delayed Start - Exercise Program
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Start - Exercise Program
n=12 participants at risk
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.
|
Immediate Start - No Exercise
n=9 participants at risk
Intervention to start immediately after first visits - Delay after program is complete.
|
Delayed Start - No Exercise
n=12 participants at risk
Intervention to start after 12 weeks delay.
|
Delayed Start - Exercise Program
n=8 participants at risk
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.
|
|---|---|---|---|---|
|
Vascular disorders
Acute intracranial hemorrage
|
0.00%
0/12 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
12.5%
1/8 • Number of events 1 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Issues
|
8.3%
1/12 • Number of events 1 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
|
Ear and labyrinth disorders
Lighheaded/Syncope
|
0.00%
0/12 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
12.5%
1/8 • Number of events 1 • 24 weeks
|
|
Renal and urinary disorders
Infection
|
0.00%
0/12 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • Number of events 1 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
|
General disorders
Pain
|
0.00%
0/12 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • Number of events 1 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Breathing Issues
|
0.00%
0/12 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
8.3%
1/12 • Number of events 1 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Closed displaced fracture of left tibial spine
|
8.3%
1/12 • Number of events 1 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
Other adverse events
| Measure |
Immediate Start - Exercise Program
n=12 participants at risk
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.
|
Immediate Start - No Exercise
n=9 participants at risk
Intervention to start immediately after first visits - Delay after program is complete.
|
Delayed Start - No Exercise
n=12 participants at risk
Intervention to start after 12 weeks delay.
|
Delayed Start - Exercise Program
n=8 participants at risk
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.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
41.7%
5/12 • Number of events 13 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
25.0%
3/12 • Number of events 3 • 24 weeks
|
62.5%
5/8 • Number of events 14 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Issues
|
33.3%
4/12 • Number of events 4 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
25.0%
2/8 • Number of events 4 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Breathing Issues
|
8.3%
1/12 • Number of events 1 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
|
General disorders
Sleep/mood disturbance
|
8.3%
1/12 • Number of events 1 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
|
General disorders
Infection
|
8.3%
1/12 • Number of events 1 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
25.0%
2/8 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Issues
|
8.3%
1/12 • Number of events 2 • 24 weeks
|
11.1%
1/9 • Number of events 1 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
|
Ear and labyrinth disorders
Lightheaded/Syncope
|
8.3%
1/12 • Number of events 1 • 24 weeks
|
11.1%
1/9 • Number of events 1 • 24 weeks
|
8.3%
1/12 • Number of events 1 • 24 weeks
|
0.00%
0/8 • 24 weeks
|
|
General disorders
Other
|
8.3%
1/12 • Number of events 5 • 24 weeks
|
0.00%
0/9 • 24 weeks
|
0.00%
0/12 • 24 weeks
|
12.5%
1/8 • Number of events 2 • 24 weeks
|
Additional Information
Amanda Herrmann, PhD
HealthPartners Institute Neuroscience Research Center
Phone: 651-495-6363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place