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Completed

NCT Number: NCT04971408

Impact of Passive Heat on Metabolic, Inflammatory and Vascular Health in Persons 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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Chronic Inflammation Endothelial Function Glucose Metabolism Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229-4404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passive heat stress

Other

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

Other names: water perfused suit and electrical heating blanket

Control

Other

participant engage in activity as usual

Primary outcomes

  1. Interleukin-6

    Time frame: change from 0 weeks to 8 weeks to 16 weeks

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

Secondary outcomes

  1. Maximal Cutaneous Vascular Conductance

    Time frame: change from 0 weeks to 8 weeks to 16 weeks

    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).

  2. Glucose Tolerance

    Time frame: change from 0 to 8 to 16 weeks

    glucose AUC from 3h oral glucose tolerance test

  3. TNF-alpha

    Time frame: change from 0 to 8 to 16 weeks

    plasma concentration

  4. Interleukin-1ra

    Time frame: change from 0 to 8 to 16 weeks

    plasma concentration

Other outcomes

  1. 5-item Mental Health Inventory

    Time frame: change from 0 to 8 to 16 weeks

    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.

  2. SCI Chronic Pain Survey

    Time frame: change from 0 weeks to 8 weeks to 16 weeks

    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.

  3. Daytime Sleepiness

    Time frame: change from 0 to 8 to 16 weeks

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: SCIPHS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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