RecruitingNot ApplicableNCT07317843

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

Home-Based Passive Heat Therapy-Towards a Scalable Intervention to Improve Cardiovascular Health in Persons With Spinal Cord Injury

Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

48 participants

Start Date

Mar 24, 2026

Study Type

INTERVENTIONAL

Conditions

SCI - Spinal Cord Injury

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

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.
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 Criteria9

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.
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.
Is unlikely to cooperate with the requirements of the study.

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Interventions

OTHERHEAT - 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.

OTHERSham (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.