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Spinal Cord Injury - Exercise

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HealthPartners Institute

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Behavioral: HealthPartners NeuroWell Exercise Program

Study type

Interventional

Funder types

Other

Identifiers

NCT05376449
A21-009

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Immediate start
Experimental group
Description:
Intervention to start immediately after first visits.
Treatment:
Behavioral: HealthPartners NeuroWell Exercise Program
Delayed start
Active Comparator group
Description:
Intervention to start after 12 weeks delay.
Treatment:
Behavioral: HealthPartners NeuroWell Exercise Program

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Amanda A Herrmann, PhD

Data sourced from clinicaltrials.gov

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