Cardiovascular Diseases Clinical Trial
Official title:
Cardioprotective Benefit of Passive Heat Therapy in Higher-Level Spinal Cord Injury: Safety and Proof of Concept
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 the risk of CV diseases. However, those with higher level SCI have a limited ability to exercise due to their loss of function. Heat therapy has been shown to promote significant health benefits in populations with health challenges and has demonstrated a mild exercise like response. The investigators aim to extend these findings and develop a practical passive heat therapy program appropriate for safe home use.
Status | Not yet recruiting |
Enrollment | 18 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | ICORD Blusson SPinal Cord Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Brunt VE, Eymann TM, Francisco MA, Howard MJ, Minson CT. Passive heat therapy improves cutaneous microvascular function in sedentary humans via improved nitric oxide-dependent dilation. J Appl Physiol (1985). 2016 Sep 1;121(3):716-23. doi: 10.1152/japplph — View Citation
Brunt VE, Howard MJ, Francisco MA, Ely BR, Minson CT. Passive heat therapy improves endothelial function, arterial stiffness and blood pressure in sedentary humans. J Physiol. 2016 Sep 15;594(18):5329-42. doi: 10.1113/JP272453. Epub 2016 Jun 30. — View Citation
Gass EM, Gass GC. Thermoregulatory responses to repeated warm water immersion in subjects who are paraplegic. Spinal Cord. 2001 Mar;39(3):149-55. doi: 10.1038/sj.sc.3101117. — View Citation
Larson EA, Ely BR, Francisco, MA, Brunt VE, Minson CT. Thermoregulatory Response to Acute Passive Heat Exposure in Individuals with Low-level Spinal Cord Injury. FASEB J. 2019;33(1):838.19.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Core temperature | As measured by CorTemp smart pill and the Bair Hugger system | Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes) | |
Primary | Oxygen consumption | As measured by open circuit spirometer | Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes) | |
Primary | Cardiac output | As measured indirectly by Finopres© | Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes) | |
Primary | Blood pressure | As measured indirectly by Finopres© | Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes) | |
Primary | Heart rate | As measured indirectly by Finopres© | Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes) | |
Secondary | Cerebral artery blood flow | As measured by arterial doppler ultrasound | Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes) | |
Secondary | Brachial arterial blood flow | As measured by arterial doppler ultrasound | Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes) |
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