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Clinical Trials/NCT04971408
NCT04971408CompletedNot Applicable

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

VA Office of Research and Development1 site in 1 country10 target enrollmentStarted: July 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Interleukin-6

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
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

Arms & Interventions

Control

Other

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

Intervention: Control (Other)

Passive heat stress

Experimental

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

Intervention: passive heat stress (Other)

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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