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

NCT ID: NCT04971408

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury Chronic Inflammation Glucose Metabolism Endothelial Function

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

passive heat stress with water perfused heat suits and electrical heating blankets
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control

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

Group Type OTHER

control

Intervention Type OTHER

participant engage in activity as usual

Passive heat stress

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

Group Type EXPERIMENTAL

passive heat stress

Intervention Type OTHER

as above

Interventions

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passive heat stress

as above

Intervention Type OTHER

control

participant engage in activity as usual

Intervention Type OTHER

Other Intervention Names

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water perfused suit and electrical heating blanket

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle B Trbovich, MD

Role: PRINCIPAL_INVESTIGATOR

South Texas Health Care System, San Antonio, TX

Locations

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South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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B3724-P

Identifier Type: -

Identifier Source: org_study_id

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