Impact of Passive Heat on Metabolic, Inflammatory and Vascular Health in Persons With Spinal Cord Injury

Study Overview
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Brief Summary
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SCI results in higher incidence of heart disease and diabetes and heart disease is the most common cause of death. Chronic inflammation, deleterious changes in vascular structure and impaired glucose metabolism are risk factors that contribute to both heart disease and diabetes. While exercise can help reduce these risk factors, paralysis and impaired accessibility often precludes exercise in persons with SCI. New research in able-bodied persons demonstrates passive heating decreases inflammation and improves vascular function. Similar studies in persons with SCI suggest they may also have the same health benefits however these studies only investigated the impact of short term (one episode) passive heating (as opposed to repeated bouts). Repeated bouts of heat exposure will likely be required to impact chronic inflammation, but this has never been tested in persons with SCI. This study will test the impact of repeated bouts (3x/week) of passive heat stress over a longer term (8 weeks) on inflammation, metabolism and vascular function.

Official Title
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Passive Heating as an Accessible and Tolerable Strategy to Improve the Inflammatory Profile and Cardiometabolic Health in People With Spinal Cord Injury

Conditions
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Spinal Cord Injury, Chronic Inflammation, Glucose Metabolism, Endothelial Function

Intervention / Treatment
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* Other: passive heat stress
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable SCI over 1 year of duration Exclusion Criteria: Persons who smoke cigarettes Daily administration of anti-inflammatory medications Daily administration of vasoactive medications Pressure ulcer stage 3 or 4 History of heat related illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: passive heat stress with water perfused heat suits and electrical heating blankets
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control<br>passive heat stress x1 visit then no intervention for 8 weeks. participants continue regular exercise habits as usual. | Other: control<br>* participant engage in activity as usual<br>|
| Experimental: Passive heat stress<br>After arm 1, passive heat stress 3x/week x8 weeks. | Other: passive heat stress<br>* as above<br>* Other names: water perfused suit and electrical heating blanket;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory markers | IL-6 | change from 0 to 8 to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function | cutaneous vascular conductance measured via laser doppler flowmetry | change from 0 to 8 to 16 weeks | 
| glucose metabolism via oral glucose tolerance test | oral glucose tolerance test | change from 0 to 8 to 16 weeks | 
| inflammatory marker | TNF-alpha | change from 0 to 8 to 16 weeks | 
| inflammation | IL-1 beta | change from 0 to 8 to 16 weeks | 
| inflammation | IL-10 | change from 0 to 8 to 16 weeks | 
| inflammation | Heat shock protein 72 | change from 0 to 8 to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury