Spinal Cord Injury Clinical Trial
— SCIPHSOfficial title:
Passive Heating as an Accessible and Tolerable Strategy to Improve the Inflammatory Profile and Cardiometabolic Health in People With Spinal Cord Injury
NCT number | NCT04971408 |
Other study ID # | B3724-P |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2022 |
Est. completion date | June 30, 2024 |
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | South Texas Health Care System, San Antonio, TX | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health Related Quality of Life | RAND -36 survey | change from 0 to 8 to 16 weeks | |
Other | Chronic pain | SCI Pain Questionnaire | change from 0 to 8 to 16 weeks | |
Other | Mental Health | Mental Health Inventory-5 | change from 0 to 8 to 16 weeks | |
Primary | inflammatory markers | IL-6 | change from 0 to 8 to 16 weeks | |
Secondary | endothelial function | cutaneous vascular conductance measured via laser doppler flowmetry | change from 0 to 8 to 16 weeks | |
Secondary | glucose metabolism via oral glucose tolerance test | oral glucose tolerance test | change from 0 to 8 to 16 weeks | |
Secondary | inflammatory marker | TNF-alpha | change from 0 to 8 to 16 weeks | |
Secondary | inflammation | IL-1 beta | change from 0 to 8 to 16 weeks | |
Secondary | inflammation | IL-10 | change from 0 to 8 to 16 weeks | |
Secondary | inflammation | Heat shock protein 72 | change from 0 to 8 to 16 weeks |
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