Status:
UNKNOWN
Cardioprotective Benefit of Passive Heat Therapy in Higher-Level Spinal Cord Injury: Safety and Proof of Concept
Lead Sponsor:
University of British Columbia
Conditions:
Spinal Cord Injuries
Cardiovascular Diseases
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
As compared to the general population, those living with a spinal cord injury (SCI) are at a greater risk of cardiovascular (CV) diseases.The investigators know that regular exercise can help lessen t...
Detailed Description
The risk of cardiovascular diseases for people with a spinal cord injury (SCI) is approximately 3x greater than the general population, and Cardiovascular (CV) diseases account for \~40% of deaths in ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06027502
Start Date
September 15 2023
End Date
December 1 2023
Last Update
September 7 2023
Active Locations (1)
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1
ICORD Blusson SPinal Cord Centre
Vancouver, British Columbia, Canada, V5Z 1M9