Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT06027502
Eligibility Criteria:
Inclusion Criteria:
* sedentary to active individuals living with a spinal cord injury and have injury level between T7 and C4 (of any AIS level)\*
* at least 2 years post-injury\*
* be able to do a level transfer with minimal assistance\*
* engaged in a regular and consistent bowel/bladder management program\*
* be 19 years of age or older
* be able to communicate effectively in English
* If present, self-reported well controlled/predictable orthostatic hypertension and/or autonomic dysreflexia\*
* be fully vaccinated against COVID-19 (initial 2 doses and 1 booster)
* these criteria do not apply to the non-SCI controls
Exclusion Criteria:
* smoke/use tobacco products
* have any cardiac/respiratory illness or diabetes mellitus
* known diverticulitis
* hypertensive (Systolic Blood Pressure \>140 mmHg and/or Diastolic Blood Pressure \>190 mmHg)
* scheduled MRI investigation in the 7 days following the data collection session
* take prescription medications that affect blood vessels, other than contraceptives
* have used an erectile dysfunction related medication (e.g., Viagra or Cialis) in the past 48 hours
* have unhealed fracture, or contracture, that would interfere with a simple chair to tub transfer and/or donning/doffing clothing
* have an unhealed pressure sore of any grade and/or open skin areas
* have unstable medical/psychiatric condition or substance abuse disorder that is likely to affect their ability to complete this study
* have underlying health conditions or injuries that would impact their ability to tolerate a mild exercise response or hot water immersion
* have uncontrolled orthostatic hypotension i.e., blood pressure does not return to normal within 2-3 minutes after standing or transferring\*
* have underlying health conditions that put them at greater risk for COVID-19 (e.g., respiratory illness, compromised immunity, or chronic health condition)
* have any COVID-19 related symptoms (e.g., new or worsening cough, shortness of breath, sore throat, runny nose or nasal congestion, hoarse voice, difficulty swallowing, new smell or taste disorders, nausea, vomiting, diarrhea, abdominal pain, unexplained fatigue, chills or headache)
* have a fever
* have travelled outside Canada or had close contact with anyone who has travelled outside Canada in the past 14 days
* have close contact with anyone with respiratory illness or a confirmed or probable case of COVID-19
* are currently self-isolating
* these criteria do not apply to the non-SCI controls
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06027502
Study Brief:
Protocol Section:
NCT06027502