Spinal Cord InjuriesNCT05376449

Spinal Cord Injury - Exercise

A study testing HealthPartners NeuroWell Exercise Program in people with Spinal Cord Injuries, run by HealthPartners Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Spinal Cord Injuries
What is being tested?: HealthPartners NeuroWell Exercise Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 9 May 2022to 13 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130

Other trials in United States

About this study

Official title: The Effect of an Adaptive Exercise Program on Chronic Inflammation in Spinal Cord Injury

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.

Conditions: Spinal Cord Injuries
Being tested: HealthPartners NeuroWell Exercise Program
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HealthPartners NeuroWell Exercise ProgramBehavioural
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.

Study groups in NCT05376449
Study group	Role	What they receive
Immediate start	Experimental	Intervention to start immediately after first visits. Receives: Behavioral: HealthPartners NeuroWell Exercise Program
Delayed start	Active comparator	Intervention to start after 12 weeks delay. Receives: Behavioral: HealthPartners NeuroWell Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of Exercise on Inflammation (C-reactive Protein)
Change in C-reactive protein after 12 week exercise program
Measured: 12 weeks
Effect of Exercise on Inflammation (Interleukin 6)
Change in Interleukin 6 after 12 week exercise program
Measured: 12 weeks
Effect of Exercise on Inflammation (Tumor Necrosis)
Change in Tumor Necrosis Biomarker after 12 week exercise program
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 202213 Sep 2024

First posted17 May 2022
Study start9 May 2022
Primary completion20 Jun 2024
Study completion13 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05376449
Sponsor's protocol ID: A21-009
Status last verified: Sep 2025
First submitted: 11 May 2022
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of an Adaptive Exercise Program on Chronic Inflammation in Spinal Cord Injury
ClinicalTrials.gov ID: NCT05376449
Acronym / sponsor ID: A21-009
Conditions: Spinal Cord Injuries
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: HealthPartners InstituteUniversity, hospital or other
Study start: 9 May 2022 (actual)
Primary completion: 20 Jun 2024 (actual)
Study completion: 13 Sep 2024 (actual)
First posted: 17 May 2022 (actual)
Results: Posted 20 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate start	Experimental	Behavioral: HealthPartners NeuroWell Exercise ProgramIntervention to start immediately after first visits.
Delayed start	Active comparator	Behavioral: HealthPartners NeuroWell Exercise ProgramIntervention to start after 12 weeks delay.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HealthPartners NeuroWell Exercise ProgramA 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.	Behavioural	Delayed start, Immediate start

Primary outcome

Effect of Exercise on Inflammation (C-reactive Protein)
Time frame: 12 weeks
Change in C-reactive protein after 12 week exercise program
Effect of Exercise on Inflammation (Interleukin 6)
Time frame: 12 weeks
Change in Interleukin 6 after 12 week exercise program
Effect of Exercise on Inflammation (Tumor Necrosis)
Time frame: 12 weeks
Change in Tumor Necrosis Biomarker after 12 week exercise program

Results and safety

Results posted to the registry on 20 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immediate Start	12	9
Delayed Start	12	8

Primary outcome: Effect of Exercise on Inflammation (C-reactive Protein)

Time frame: 12 weeks. Mean (Inter-Quartile Range). Unit: mg/dL

Measure	Immediate Start n = 9	Delayed Start n = 8
Value	0.00 (-0.010 to 0.010)	0.05 (0.00 to 0.55)

Primary outcome: Effect of Exercise on Inflammation (Interleukin 6)

Time frame: 12 weeks. Mean (Inter-Quartile Range). Unit: pg/mL

Measure	Immediate Start n = 8	Delayed Start n = 8
Value	-0.33 (-1.28 to -0.18)	0.50 (0.03 to 1.84)

Primary outcome: Effect of Exercise on Inflammation (Tumor Necrosis)

Time frame: 12 weeks. Mean (Inter-Quartile Range). Unit: pg/mL

Measure	Immediate Start n = 8	Delayed Start n = 8
Value	-2 (-3 to 6)	2 (-2 to 5)

Adverse events

Time frame: 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Start - Exercise Program	2 of 12 (16.7%)	9 of 12 (75%)	0 of 12
Immediate Start - No Exercise	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Delayed Start - No Exercise	3 of 12 (25%)	4 of 12 (33.3%)	0 of 12
Delayed Start - Exercise Program	2 of 8 (25%)	5 of 8 (62.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amanda A Herrmann, PhD principal investigator

HealthPartners Neuroscience Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HealthPartners NeuroWell Exercise Program in people with Spinal Cord Injuries, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Exercise on Inflammation (C-reactive Protein) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05376449.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.