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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2024
Source VA Office of Research and Development
Contact Michelle B Trbovich, MD
Phone (210) 617-5300
Email michelle.trbovich@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
passive heat stress
as above
control
participant engage in activity as usual

Locations

Country Name City State
United States South Texas Health Care System, San Antonio, TX San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

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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