Spinal Cord InjurySCIPHSNCT04971408

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

A study testing passive heat stress in people with Spinal Cord Injury and Chronic Inflammation, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Spinal Cord Injury, Chronic Inflammation, Glucose Metabolism
What is being tested?: passive heat stress
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2022to 30 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Stable SCI over 1 year of duration

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229-4404

Other trials in United States

About this study

Official title: Passive Heating as an Accessible and Tolerable Strategy to Improve the Inflammatory Profile and Cardiometabolic Health in People 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.

Conditions: Spinal Cord Injury, Chronic Inflammation, Glucose Metabolism, Endothelial Function
Being tested: passive heat stress, Control
Keywords: spinal cord injury
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

passive heat stressOther
Also called water perfused suit and electrical heating blanket
After arm 1, passive heat stress 3x/week x8 weeks.
ControlOther
participant engage in activity as usual

Study groups in NCT04971408
Study group	Role	What they receive
Control	Other	Passive heat stress x1 visit then no intervention for 8 weeks. Participants continue regular exercise habits as usual. Receives: Other: Control
Passive heat stress	Experimental	After arm 1, passive heat stress 3x/week x8 weeks. Receives: Other: passive heat stress

What is being measured

The primary outcome is the main question the study is designed to answer.

Interleukin-6
Plasma concentration, which was determined using enzyme-linked immunosorbent assays.
Measured: change from 0 weeks to 8 weeks to 16 weeks

Secondary outcomes (4)

Maximal Cutaneous Vascular Conductance
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).
Measured: change from 0 weeks to 8 weeks to 16 weeks
Glucose Tolerance
glucose AUC from 3h oral glucose tolerance test
Measured: change from 0 to 8 to 16 weeks
TNF-alpha
plasma concentration
Measured: change from 0 to 8 to 16 weeks
Interleukin-1ra
plasma concentration
Measured: change from 0 to 8 to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202230 Jun 2024

First posted21 Jul 2021
Study start1 Jul 2022
Primary completion30 Jun 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Crossover
Model description: passive heat stress with water perfused heat suits and electrical heating blankets
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04971408
Sponsor's protocol ID: B3724-P
Acronym: SCIPHS
Status last verified: Feb 2026
First submitted: 9 Jul 2021
Last updated: 6 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Spinal Cord Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Passive Heating as an Accessible and Tolerable Strategy to Improve the Inflammatory Profile and Cardiometabolic Health in People With Spinal Cord Injury
ClinicalTrials.gov ID: NCT04971408
Acronym / sponsor ID: SCIPHS / B3724-P
Conditions: Spinal Cord Injury, Chronic Inflammation, Glucose Metabolism, Endothelial Function
Keywords: spinal cord injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Jul 2022 (actual)
Primary completion: 30 Jun 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 21 Jul 2021 (actual)
Results: Posted 6 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: passive heat stress with water perfused heat suits and electrical heating blankets

Arm	Type	Receives
Control	Other	Other: ControlPassive heat stress x1 visit then no intervention for 8 weeks. Participants continue regular exercise habits as usual.
Passive heat stress	Experimental	Other: passive heat stressAfter arm 1, passive heat stress 3x/week x8 weeks.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Stable SCI over 1 year of duration

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
passive heat stressAlso: water perfused suit and electrical heating blanketAfter arm 1, passive heat stress 3x/week x8 weeks.	Other	Passive heat stress
Controlparticipant engage in activity as usual	Other	Control

Primary outcome

Interleukin-6
Time frame: change from 0 weeks to 8 weeks to 16 weeks
Plasma concentration, which was determined using enzyme-linked immunosorbent assays.

4 secondary outcomes

Maximal Cutaneous Vascular Conductance
Time frame: change from 0 weeks to 8 weeks to 16 weeks
Glucose Tolerance
Time frame: change from 0 to 8 to 16 weeks
TNF-alpha
Time frame: change from 0 to 8 to 16 weeks
Interleukin-1ra
Time frame: change from 0 to 8 to 16 weeks

Results and safety

Results posted to the registry on 6 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
8 Week Time-Control Phase, Then 8 Week Passive Heating Intervention	10	10

Primary outcome: Interleukin-6

Time frame: change from 0 weeks to 8 weeks to 16 weeks. Mean (Standard Deviation). Unit: pg/ml

Measure	Passive Heating Intervention (Preceded by a Time-control Phase) n = 10
Baseline	6.17 (4.72)
Control	5.30 (3.94)
Intervention	6.41 (3.98)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: For each individual participant the study time frame was as follows: Baseline Assessments - 8 weeks Control - Assessments - 8 weeks Passive heating Intervention - Post Assessments. Therefore, study participation lasted between 17 - 19 weeks for each participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Passive Heating Intervention	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Limitations and caveats (from the sponsor): Aside from the small sample size, the generalizability of the results is limited by the inclusion of Veterans only. Veterans likely have different experiences with mental health, sleep, and pain compared to non-veterans. Follow-up studies should include a control group, preferably one that undergoes a sham-control intervention. Lastly, the investigators did not account for medication use during the study period, such as those that may impact mental health, sleep, or pain.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Spinal Cord Injury

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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michelle B Trbovich, MD principal investigator

South Texas Health Care System, San Antonio, TX

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing passive heat stress in people with Spinal Cord Injury and Chronic Inflammation, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interleukin-6 (time frame: change from 0 weeks to 8 weeks to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04971408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.