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

NCT04971408 | Completed Results

• 1 other identifier: B3724-P
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Chronic Inflammation; Glucose Metabolism; Endothelial Function

Keywords

spinal cord injury

Outcome Measures

Primary Outcomes (1)

• Interleukin-6

  Plasma concentration, which was determined using enzyme-linked immunosorbent assays.

  change from 0 weeks to 8 weeks to 16 weeks

Secondary Outcomes (4)

• Maximal Cutaneous Vascular Conductance

  change from 0 weeks to 8 weeks to 16 weeks

• Glucose Tolerance

  change from 0 to 8 to 16 weeks

• TNF-alpha

  change from 0 to 8 to 16 weeks

• Interleukin-1ra

  change from 0 to 8 to 16 weeks

Other Outcomes (3)

• 5-item Mental Health Inventory

  change from 0 to 8 to 16 weeks

• SCI Chronic Pain Survey

  change from 0 weeks to 8 weeks to 16 weeks

• Daytime Sleepiness

  change from 0 to 8 to 16 weeks

Study Arms (2)

Control

OTHER

Passive heat stress x1 visit then no intervention for 8 weeks. Participants continue regular exercise habits as usual.

Other: Control

Passive heat stress

EXPERIMENTAL

After arm 1, passive heat stress 3x/week x8 weeks.

Other: passive heat stress

Interventions

passive heat stress OTHER

After arm 1, passive heat stress 3x/week x8 weeks.

Also known as: water perfused suit and electrical heating blanket

Passive heat stress

Control OTHER

participant engage in activity as usual

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Stable SCI over 1 year of duration

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229-4404, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

Aside from the small sample size, the generalizability of the results is limited by the inclusion of Veterans only. Veterans likely have different experiences with mental health, sleep, and pain compared to non-veterans. Follow-up studies should include a control group, preferably one that undergoes a sham-control intervention. Lastly, the investigators did not account for medication use during the study period, such as those that may impact mental health, sleep, or pain.

Results Point of Contact

• Title: Dr. Michelle Trbovich, MD
• Organization: South Texas Veteran's Health Care System

trbovichm@uthscsa.edu

2106175300

Study Officials

• Michelle B Trbovich, MD

  South Texas Health Care System, San Antonio, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: passive heat stress with water perfused heat suits and electrical heating blankets

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 21, 2021
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)