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

Overview

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.

Full Title of Study: “Passive Heating as an Accessible and Tolerable Strategy to Improve the Inflammatory Profile and Cardiometabolic Health in People With Spinal Cord Injury”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2023

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • inflammatory markers
    • Time Frame: change from 0 to 8 to 16 weeks
    • IL-1 beta
  • glucose metabolism via oral glucose tolerance test
    • Time Frame: change from 0 to 8 to 16 weeks
    • oral glucose tolerance test
  • inflammatory marker
    • Time Frame: change from 0 to 8 to 16 weeks
    • IL-6
  • inflammation
    • Time Frame: change from 0 to 8 to 16 weeks
    • TNF-alpha
  • inflammation
    • Time Frame: change from 0 to 8 to 16 weeks
    • IL-10
  • inflammation
    • Time Frame: change from 0 to 8 to 16 weeks
    • Heat shock protein 72

Secondary Measures

  • endothelial function
    • Time Frame: change from 0 to 8 to 16 weeks
    • cutaneous vascular conductance measured via laser doppler flowmetry

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Office of Research and Development
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michelle B Trbovich, MD, Principal Investigator, South Texas Health Care System, San Antonio, TX
  • Overall Contact(s)
    • Michelle B Trbovich, MD, (210) 617-5300, michelle.trbovich@va.gov

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