Clinical trial NCT04971408: Impact of Passive Heat on Metabolic, Inflammatory and Vascular Health in Persons With Spinal Cord Injury
Official title: Passive Heating as an Accessible and Tolerable Strategy to Improve the Inflammatory Profile and Cardiometabolic Health in People With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Chronic Inflammation
Glucose Metabolism
Endothelial Function
Keywords: spinal cord injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: passive heat stress with water perfused heat suits and electrical heating blankets
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: inflammatory markers
timeFrame: change from 0 to 8 to 16 weeks
Secondary outcomes:
measure: endothelial function
timeFrame: change from 0 to 8 to 16 weeks
measure: glucose metabolism via oral glucose tolerance test
timeFrame: change from 0 to 8 to 16 weeks
measure: inflammatory marker
timeFrame: change from 0 to 8 to 16 weeks
measure: inflammation
timeFrame: change from 0 to 8 to 16 weeks
measure: inflammation
timeFrame: change from 0 to 8 to 16 weeks
measure: inflammation
timeFrame: change from 0 to 8 to 16 weeks
Other outcomes:
measure: Health Related Quality of Life
timeFrame: change from 0 to 8 to 16 weeks
measure: Chronic pain
timeFrame: change from 0 to 8 to 16 weeks
measure: Mental Health
timeFrame: change from 0 to 8 to 16 weeks
Locations:
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
Study officials:
affiliation: South Texas Health Care System, San Antonio, TX
name: Michelle B Trbovich, MD
role: PRINCIPAL_INVESTIGATOR
References: