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

Primary Purpose

Spinal Cord Injury, Chronic Inflammation, Glucose Metabolism

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
passive heat stress
control
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury focused on measuring spinal cord injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Texas Health Care System, San Antonio, TXRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control

Passive heat stress

Arm Description

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

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

Outcomes

Primary Outcome Measures

inflammatory markers
IL-6

Secondary Outcome Measures

endothelial function
cutaneous vascular conductance measured via laser doppler flowmetry
glucose metabolism via oral glucose tolerance test
oral glucose tolerance test
inflammatory marker
TNF-alpha
inflammation
IL-1 beta
inflammation
IL-10
inflammation
Heat shock protein 72

Full Information

First Posted
July 9, 2021
Last Updated
June 15, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04971408
Brief Title
Impact of Passive Heat on Metabolic, Inflammatory and Vascular Health in Persons With Spinal Cord Injury
Acronym
SCIPHS
Official Title
Passive Heating as an Accessible and Tolerable Strategy to Improve the Inflammatory Profile and Cardiometabolic Health in People With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Chronic Inflammation, Glucose Metabolism, Endothelial Function
Keywords
spinal cord injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
passive heat stress with water perfused heat suits and electrical heating blankets
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Other
Arm Description
passive heat stress x1 visit then no intervention for 8 weeks. participants continue regular exercise habits as usual.
Arm Title
Passive heat stress
Arm Type
Experimental
Arm Description
After arm 1, passive heat stress 3x/week x8 weeks.
Intervention Type
Other
Intervention Name(s)
passive heat stress
Other Intervention Name(s)
water perfused suit and electrical heating blanket
Intervention Description
as above
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
participant engage in activity as usual
Primary Outcome Measure Information:
Title
inflammatory markers
Description
IL-6
Time Frame
change from 0 to 8 to 16 weeks
Secondary Outcome Measure Information:
Title
endothelial function
Description
cutaneous vascular conductance measured via laser doppler flowmetry
Time Frame
change from 0 to 8 to 16 weeks
Title
glucose metabolism via oral glucose tolerance test
Description
oral glucose tolerance test
Time Frame
change from 0 to 8 to 16 weeks
Title
inflammatory marker
Description
TNF-alpha
Time Frame
change from 0 to 8 to 16 weeks
Title
inflammation
Description
IL-1 beta
Time Frame
change from 0 to 8 to 16 weeks
Title
inflammation
Description
IL-10
Time Frame
change from 0 to 8 to 16 weeks
Title
inflammation
Description
Heat shock protein 72
Time Frame
change from 0 to 8 to 16 weeks
Other Pre-specified Outcome Measures:
Title
Quality of Life
Description
RAND survey
Time Frame
change from 0 to 8 to 16 weeks
Title
Chronic pain
Description
SCI Pain Questionnaire
Time Frame
change from 0 to 8 to 16 weeks
Title
Mental Health
Description
MHI-5
Time Frame
change from 0 to 8 to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle B Trbovich, MD
Phone
(210) 617-5300
Ext
16986
Email
michelle.trbovich@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon K Stowe
Phone
(210) 617-5300
Ext
16845
Email
Sharon.Stowe@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle B Trbovich, MD
Organizational Affiliation
South Texas Health Care System, San Antonio, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Texas Health Care System, San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle B Trbovich, MD
Phone
210-617-5300
Ext
16986
Email
michelle.trbovich@va.gov
First Name & Middle Initial & Last Name & Degree
Sharon K Stowe
Phone
(210) 617-5300
Ext
16845
Email
Sharon.Stowe@va.gov
First Name & Middle Initial & Last Name & Degree
Michelle B Trbovich, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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