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

Spinal Cord Injury Clinical Trial

— SCIPHS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04971408
• Other study ID #: B3724-P
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Inflammation
• Endothelial Function
• Glucose Metabolism
• Inflammation
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

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