Recruiting

Passive Heat Therapy

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07317843

Conditions

SCI - Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

HEAT - Passive Heat Therapy

Sham (No Treatment)

Study Details

Brief summary:

The study is designed to investigate the effects of passive heat therapy on blood vessel health in 40 people (48 enrolled with attrition rate of 20%). Following an extensive set of vascular function tests, participants will engage in either a passive heat therapy intervention for 60 minutes, 4 times a week for 8 weeks, or a placebo intervention at a lower temperature. Seven of the 8 weeks of intervention will occur in the home setting. Vascular function tests will be repeated after the 8 weeks to determine if chronic passive heat stress improved vascular health.

Conditions

SCI - Spinal Cord Injury

Study ID

NCT07317843

Start date

Mar 24, 2026

Status verified date

Apr, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent.
2. Participants will be male or female, 18-60 years of age, at the time of Visit 0.
3. Female participants must be non-lactating. Female patients are eligible only if they have a negative pregnancy test throughout the study period (or are postmenopausal). Postmenopausal women taking hormone replacement will be included if they have been on a stable dose for =6 months.
4. Stable SCI (AIS A or B) of longer than 1-year duration.
5. Use of medications for clinical management of medical problems directly related to SCI is not considered an exclusion criterion. Status such as detrusor instability, muscle spasms, and other common SCI problems (other than those that could alter vascular responsiveness) may be allowed for those SCI participants who have been on stable doses for =6 months. Results from participants taking such medications will be analyzed to determine possible medication-related differences from those on no medications.

Exclusion Criteria:

1. Participants who smoke, or:
2. Uses daily administration of anti-inflammatory medications (stable doses of NSAIDs or statins are acceptable; steroids are exclusionary)
3. Uses daily administration of vasoactive medications (e.g., alpha antagonists or agonists or phosphodiesterase inhibitors).
4. Has a current pressure ulcer or skin breakdown.
5. Has an active, uncontrolled, autoimmune or inflammatory disorder
6. Has no history of or current alcohol or substance use disorder
7. Has a history of heat related illness (e.g., heat stroke)
8. Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study. This includes, but is not limited to, a clinically relevant medical or surgical history.
9. Is unlikely to cooperate with the requirements of the study.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HEAT

The experimental arm (HEAT) participants undergo an 8-week intervention with 4 weekly passive heat therapy sessions (home based for 7 of 8 weeks) using an electrical heating blanket at a temperature of 42 degrees C.

sham comparator: SHAM

For participants in SHAM, the heating blankets will be warm (\~34°C) but will not reach a temperature that elevates core temperature. As in the HEAT arm, sessions will be home based for 7 of 8 weeks.

Interventions

HEAT - Passive Heat Therapy

Participant rests under a heated blanket until the core body temperature has increased at minimum 1 degree Celsius. This usually takes approximately 1 hour. The intervention is performed 4 times a week for a total of 8 weeks.

Sham (No Treatment)

The SHAM intervention participant will rest under a heated blanket that is not set to the degree that the HEAT arm receives. There is no increase of core body temperature.

Primary outcome measure

  • Laser Doppler Flowmetry (LDF) [ Time Frame: From baseline to end of treatment at 8 weeks ]

Central Contacts and Locations

Central contacts

Dean L Kellogg, Jr, MD, PhD

210-617-5300kelloggd@uthscsa.edu

Locations

Audie L Murphy Veterans Memorial Hospital, South Texas Veterans Health Care System

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • SCI
  • heat therapy
  • heat stress
  • passive heat
  • vascular function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-05-05.