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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT04971408
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: passive heat stress
  • Other: control
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
passive heat stress with water perfused heat suits and electrical heating blanketspassive heat stress with water perfused heat suits and electrical heating blankets
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Passive Heating as an Accessible and Tolerable Strategy to Improve the Inflammatory Profile and Cardiometabolic Health in People With Spinal Cord Injury
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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
Experimental: Passive heat stress

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

Other: passive heat stress
as above
Other Names:
  • water perfused suit and electrical heating blanket

    		•

    Outcome Measures

    Primary Outcome Measures

    1. inflammatory markers [change from 0 to 8 to 16 weeks]

      IL-1 beta

    2. glucose metabolism via oral glucose tolerance test [change from 0 to 8 to 16 weeks]

      oral glucose tolerance test

    3. inflammatory marker [change from 0 to 8 to 16 weeks]

      IL-6

    4. inflammation [change from 0 to 8 to 16 weeks]

      TNF-alpha

    5. inflammation [change from 0 to 8 to 16 weeks]

      IL-10

    6. inflammation [change from 0 to 8 to 16 weeks]

      Heat shock protein 72

    Secondary Outcome Measures

    1. endothelial function [change from 0 to 8 to 16 weeks]

      cutaneous vascular conductance measured via laser doppler flowmetry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South Texas Health Care System, San Antonio, TX San Antonio Texas United States 78229

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Michelle B Trbovich, MD, South Texas Health Care System, San Antonio, TX

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT04971408
    Other Study ID Numbers:
    • B3724-P
    First Posted:
    Jul 21, 2021
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by VA Office of Research and Development
    spinal cord injury
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Inflammation
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 18, 2022