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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Inflammation; Spinal Cord Injury; Glucose Metabolism; Endothelial Function
• Intervention / Treatment: Other: Control; Other: passive heat stress

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229-4404
      • South Texas Health Care System, San Antonio, TX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Passive heat stress; After arm 1, passive heat stress 3x/week x8 weeks.	Other: passive heat stress; After arm 1, passive heat stress 3x/week x8 weeks.; Other Names: water perfused suit and electrical heating blanket
Other: Control; Passive heat stress x1 visit then no intervention for 8 weeks. Participants continue regular exercise habits as usual.	Other: Control; participant engage in activity as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin-6	Plasma concentration, which was determined using enzyme-linked immunosorbent assays.	change from 0 weeks to 8 weeks to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Cutaneous Vascular Conductance	Cutaneous vascular conductance (CVC) in response to local heating measured via laser doppler flowmetry. Following heating of the skin for 10 min at a temperature of 34C, the skin was locally heated to 45C, which was maintained for at least 30 min (maximal CVC). The values in the data table reflect the percentage of maximum conductance of the skin at 34 degrees Celsius, when the skin is heated to 45 degrees Celsius at each time point (i.e., baseline, after control, and after intervention).	change from 0 weeks to 8 weeks to 16 weeks
Glucose Tolerance	glucose AUC from 3h oral glucose tolerance test	change from 0 to 8 to 16 weeks
TNF-alpha	plasma concentration	change from 0 to 8 to 16 weeks
Interleukin-1ra	plasma concentration	change from 0 to 8 to 16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-item Mental Health Inventory	Mental Health Inventory (MHI)-5 survey. This 5-item instrument assesses frequency of various emotional states with a 0-6 score per item. Responses were scored and transformed to a 0-100 scale. Higher scores mean better mental health.	change from 0 to 8 to 16 weeks
SCI Chronic Pain Survey	Perceived pain intensity and frequency, reported using a survey specifically developed for persons with spinal cord injury. It asks participants to report on the pain intensity in the present moment on a scale from 0 to 10. Higher scores indicate more severe and/or frequent pain.	change from 0 weeks to 8 weeks to 16 weeks
Daytime Sleepiness	The Epworth Sleepiness Scale is a 7-item questionnaire that measures daytime sleepiness in various situations using a 0-3 score per item. Total score 0 - 21. The sum-score is used as outcome measure. A higher score is indicative of more excessive daytime sleepiness.	change from 0 to 8 to 16 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Michelle B Trbovich, MD, South Texas Health Care System, San Antonio, TX

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: spinal cord injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: B3724-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No