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SCI results in higher incidence of heart disease and diabetes and heart disease is the most common cause of death. Chronic inflammation, deleterious changes in vascular structure and impaired glucose metabolism are risk factors that contribute to both heart disease and diabetes. While exercise can help reduce these risk factors, paralysis and impaired accessibility often precludes exercise in persons with SCI. New research in able-bodied persons demonstrates passive heating decreases inflammation and improves vascular function. Similar studies in persons with SCI suggest they may also have the same health benefits however these studies only investigated the impact of short term (one episode) passive heating (as opposed to repeated bouts). Repeated bouts of heat exposure will likely be required to impact chronic inflammation, but this has never been tested in persons with SCI. This study will test the impact of repeated bouts (3x/week) of passive heat stress over a longer term (8 weeks) on inflammation, metabolism and vascular function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Passive heat stress x1 visit then no intervention for 8 weeks. Participants continue regular exercise habits as usual. |
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| Passive heat stress | Experimental | After arm 1, passive heat stress 3x/week x8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| passive heat stress | Other | After arm 1, passive heat stress 3x/week x8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-6 | Plasma concentration, which was determined using enzyme-linked immunosorbent assays. | change from 0 weeks to 8 weeks to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Cutaneous Vascular Conductance | Cutaneous vascular conductance (CVC) in response to local heating measured via laser doppler flowmetry. Following heating of the skin for 10 min at a temperature of 34C, the skin was locally heated to 45C, which was maintained for at least 30 min (maximal CVC). The values in the data table reflect the percentage of maximum conductance of the skin at 34 degrees Celsius, when the skin is heated to 45 degrees Celsius at each time point (i.e., baseline, after control, and after intervention). |
| Measure | Description | Time Frame |
|---|---|---|
| 5-item Mental Health Inventory | Mental Health Inventory (MHI)-5 survey. This 5-item instrument assesses frequency of various emotional states with a 0-6 score per item. Responses were scored and transformed to a 0-100 scale. Higher scores mean better mental health. | change from 0 to 8 to 16 weeks |
| SCI Chronic Pain Survey |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle B Trbovich, MD | South Texas Health Care System, San Antonio, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Health Care System, San Antonio, TX | San Antonio | Texas | 78229-4404 | United States |
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Each enrolled participant completed a time-control phase of 8 weeks prior to the passive heating intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | 8 Week Time-Control Phase, Then 8 Week Passive Heating Intervention | This was a single-arm intervention study with time control phase. Following baseline assessments, participants continued their usual life for 8 weeks, followed by the same assessments. Thereafter, the same group of participants engaged in an 8-week passive heating intervention; followed by the same assessments again. Thus, in summary, the design was as follows: "Baseline assessments" ----- 8 week time-control phase --- "Control assessments" ---- 8-week passive heating intervention ---- "Intervention assessments" |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Control |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2022 |
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passive heat stress with water perfused heat suits and electrical heating blankets
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| Control | Other | participant engage in activity as usual |
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| change from 0 weeks to 8 weeks to 16 weeks |
| Glucose Tolerance | glucose AUC from 3h oral glucose tolerance test | change from 0 to 8 to 16 weeks |
| TNF-alpha | plasma concentration | change from 0 to 8 to 16 weeks |
| Interleukin-1ra | plasma concentration | change from 0 to 8 to 16 weeks |
Perceived pain intensity and frequency, reported using a survey specifically developed for persons with spinal cord injury. It asks participants to report on the pain intensity in the present moment on a scale from 0 to 10. Higher scores indicate more severe and/or frequent pain. |
| change from 0 weeks to 8 weeks to 16 weeks |
| Daytime Sleepiness | The Epworth Sleepiness Scale is a 7-item questionnaire that measures daytime sleepiness in various situations using a 0-3 score per item. Total score 0 - 21. The sum-score is used as outcome measure. A higher score is indicative of more excessive daytime sleepiness. | change from 0 to 8 to 16 weeks |
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| Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants with spinal cord injury |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Years since injury | Mean | Standard Deviation | years |
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| BMI in kg/m2 | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Interleukin-6 | Plasma concentration, which was determined using enzyme-linked immunosorbent assays. | Posted | Mean | Standard Deviation | pg/ml | change from 0 weeks to 8 weeks to 16 weeks |
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| Secondary | Maximal Cutaneous Vascular Conductance | Cutaneous vascular conductance (CVC) in response to local heating measured via laser doppler flowmetry. Following heating of the skin for 10 min at a temperature of 34C, the skin was locally heated to 45C, which was maintained for at least 30 min (maximal CVC). The values in the data table reflect the percentage of maximum conductance of the skin at 34 degrees Celsius, when the skin is heated to 45 degrees Celsius at each time point (i.e., baseline, after control, and after intervention). | Posted | Mean | Standard Deviation | % of maximum conductance from 34C | change from 0 weeks to 8 weeks to 16 weeks |
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| Secondary | Glucose Tolerance | glucose AUC from 3h oral glucose tolerance test | Posted | Mean | Standard Deviation | mg/l * 180 min | change from 0 to 8 to 16 weeks |
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| Secondary | TNF-alpha | plasma concentration | Posted | Mean | Standard Deviation | pg/ml | change from 0 to 8 to 16 weeks |
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| Secondary | Interleukin-1ra | plasma concentration | Posted | Mean | Standard Deviation | pg/ml | change from 0 to 8 to 16 weeks |
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| Other Pre-specified | 5-item Mental Health Inventory | Mental Health Inventory (MHI)-5 survey. This 5-item instrument assesses frequency of various emotional states with a 0-6 score per item. Responses were scored and transformed to a 0-100 scale. Higher scores mean better mental health. | Posted | Mean | Standard Deviation | units on a scale | change from 0 to 8 to 16 weeks |
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| Other Pre-specified | SCI Chronic Pain Survey | Perceived pain intensity and frequency, reported using a survey specifically developed for persons with spinal cord injury. It asks participants to report on the pain intensity in the present moment on a scale from 0 to 10. Higher scores indicate more severe and/or frequent pain. | Posted | Median | Inter-Quartile Range | units on a scale | change from 0 weeks to 8 weeks to 16 weeks |
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| Other Pre-specified | Daytime Sleepiness | The Epworth Sleepiness Scale is a 7-item questionnaire that measures daytime sleepiness in various situations using a 0-3 score per item. Total score 0 - 21. The sum-score is used as outcome measure. A higher score is indicative of more excessive daytime sleepiness. | Posted | Mean | Standard Deviation | units on a scale | change from 0 to 8 to 16 weeks |
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For each individual participant the study time frame was as follows: Baseline Assessments - 8 weeks Control - Assessments - 8 weeks Passive heating Intervention - Post Assessments. Therefore, study participation lasted between 17 - 19 weeks for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | There were no adverse events; all participants completed this study phase | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | Passive Heating Intervention | There were no adverse events related to the intervention. One participant withdrew after 18 sessions due to an unrelated event. This adverse event was categorized in the "adverse event unrelated to the intervention" category, and was a reoccurring pressure injury. | 0 | 10 | 0 | 10 | 1 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse events unrelated to the intervention | Skin and subcutaneous tissue disorders | Systematic Assessment | Reoccurring issues with skin integrity that existed from prior to study participation |
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Aside from the small sample size, the generalizability of the results is limited by the inclusion of Veterans only. Veterans likely have different experiences with mental health, sleep, and pain compared to non-veterans. Follow-up studies should include a control group, preferably one that undergoes a sham-control intervention. Lastly, the investigators did not account for medication use during the study period, such as those that may impact mental health, sleep, or pain.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle Trbovich, MD | South Texas Veteran's Health Care System | 2106175300 | trbovichm@uthscsa.edu |
| Jul 25, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 5, 2023 | Jul 17, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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