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Adaptive Exercise Program for Spinal Cord Injury
N/A
Waitlist Available
Led By Amanda A Herrmann, PhD
Research Sponsored by HealthPartners Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Age 18-70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will test whether a 12-week adaptive exercise program can reduce inflammation in people with SCI, who are often inactive.
Who is the study for?
This trial is for adults aged 18-70 with spinal cord injury (SCI) who are at least 6 months post-injury, can move their elbows, wrists, and shoulders enough to do the exercises, and can consent. It's not for non-English speakers, those with conditions limiting exercise like heart failure or severe spasms, pregnant individuals, or anyone in another study recently.Check my eligibility
What is being tested?
The HealthPartners NeuroWell Exercise Program is being tested to see if it reduces inflammation in people with SCI. Participants will be randomly assigned to either start a 12-week adaptive exercise program immediately or after a delay of the same duration.See study design
What are the potential side effects?
Since this trial involves an exercise program designed for individuals with SCI, side effects may include muscle soreness or fatigue. However, participants with conditions that could worsen due to exercise have been excluded from the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can move my elbow, wrist, and shoulder well enough to do study tasks.
Select...
I am between 18 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of exercise on inflammation (C-reactive protein)
Effect of exercise on inflammation (Interleukin 6)
Effect of exercise on inflammation (Tumor Necrosis)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate startExperimental Treatment1 Intervention
Intervention to start immediately after first visits.
Group II: Delayed startActive Control1 Intervention
Intervention to start after 12 weeks delay.
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Who is running the clinical trial?
HealthPartners InstituteLead Sponsor
184 Previous Clinical Trials
3,716,135 Total Patients Enrolled
Amanda A Herrmann, PhDPrincipal InvestigatorHealthPartners Neuroscience Research
2 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any cognitive issues that prevent me from participating.I need a machine to help me breathe.My spasms prevent me from joining in study activities.I do not speak English.I have been advised not to twist, bend excessively, reach overhead, or lift over 10 pounds.I can move my elbow, wrist, and shoulder well enough to do study tasks.I have severe and uncontrolled autonomic dysreflexia.I am between 18 and 70 years old.I have been diagnosed with a spinal cord injury for over 6 months.I have a condition like heart failure or lung disease that makes me unusually short of breath.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate start
- Group 2: Delayed start
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the demographic of individuals eligible to participate in this experiment?
"This medical trial is recruiting approximately 20 people, who must have spinal cord injuries and be between 18-70 years old."
Answered by AI
What is the current subject population of this trial?
"Affirmative. The clinical trial, first posted on May 9th 2022, is still searching for participants and has recently been updated (June 14th 2022). 20 patients will be recruited from a single site."
Answered by AI
Are there any vacancies left for participants in this research?
"Per the information collected on clinicaltrials.gov, this medical experiment is still recruiting participants. The original posting date was May 9th 2022 and the most recent amendment can be dated back to June 14th 2022."
Answered by AI
Does this research project encompass individuals aged 55 and over?
"Patients over the age of 18 and below 70 years old are eligible to join this clinical trial."
Answered by AI
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