Home-Based Heat Therapy in Spinal Cord Injury to Improve Cardiovascular Health

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07317843
Status
Recruiting
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Conditions

  • SCI - Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • HEAT - Passive Heat Therapy — OTHER
    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) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Mar 24, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Audie L Murphy Veterans Memorial Hospital, South Texas Veterans Health Care SystemSan AntonioTexas78229
Michelle Paprocki, RN

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Audie L Murphy Veterans Memorial Hospital, South Texas Veterans Health Care System· San Antonio, TX

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