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

Not Applicable

Completed

• Conditions: Spinal Cord Injury; Glucose Metabolism; Chronic Inflammation; Endothelial Function
• Interventions: Other: passive heat stress; Other: control

• Registration Number: NCT04971408
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-21
• Study Start: 2022-07-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Passive heat stress	passive heat stress	After arm 1, passive heat stress 3x/week x8 weeks.
control	control	passive heat stress x1 visit then no intervention for 8 weeks. participants continue regular exercise habits as usual.

Primary Outcome Measures

Name	Time	Method
inflammatory markers	change from 0 to 8 to 16 weeks	IL-6

Secondary Outcome Measures

Name	Time	Method
endothelial function	change from 0 to 8 to 16 weeks	cutaneous vascular conductance measured via laser doppler flowmetry
glucose metabolism via oral glucose tolerance test	change from 0 to 8 to 16 weeks	oral glucose tolerance test
inflammatory marker	change from 0 to 8 to 16 weeks	TNF-alpha
inflammation	change from 0 to 8 to 16 weeks	Heat shock protein 72

Trial Locations

Locations (1)

South Texas Health Care System, San Antonio, TX; 🇺🇸 San Antonio, Texas, United States