NCT07317843 · The University of Texas Health Science Center at San Antonio
Home-Based Heat Therapy in Spinal Cord Injury to Improve Cardiovascular Health
(IIS_SCIDoD)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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.
OTHER
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 measures
Laser Doppler Flowmetry (LDF)
Time frame: From baseline to end of treatment at 8 weeks
Measure of skin blood flow due to local skin heating
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Use of medications for clinical management of medical problems directly related to SCI is not considered an
Exclusion criteria
- 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:
- 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.
Where
- San Antonio, Texas
Collaborators
Congressionally Directed Medical Research Programs
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations