Home-Based Heat Therapy in Spinal Cord Injury to Improve Cardiovascular Health (NCT07317843) | Clinical Trial Compass
RecruitingNot Applicable
Home-Based Heat Therapy in Spinal Cord Injury to Improve Cardiovascular Health
United States48 participantsStarted 2026-03-24
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent.
✓. Participants will be male or female, 18-60 years of age, at the time of Visit 0.
✓. 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.
✓. Stable SCI (AIS A or B) of longer than 1-year duration.
Exclusion criteria
✕. Participants who smoke, or:
✕. Uses daily administration of anti-inflammatory medications (stable doses of NSAIDs or statins are acceptable; steroids are exclusionary)
✕. Uses daily administration of vasoactive medications (e.g., alpha antagonists or agonists or phosphodiesterase inhibitors).
✕. Has a current pressure ulcer or skin breakdown.
What they're measuring
1
Laser Doppler Flowmetry (LDF)
Timeframe: From baseline to end of treatment at 8 weeks
Trial details
NCT IDNCT07317843
SponsorThe University of Texas Health Science Center at San Antonio
. Has an active, uncontrolled, autoimmune or inflammatory disorder
✕. Has no history of or current alcohol or substance use disorder
✕. Has a history of heat related illness (e.g., heat stroke)
✕. 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.