Trial Outcomes & Findings for Impact of Passive Heat on Metabolic, Inflammatory and Vascular Health in Persons With Spinal Cord Injury (NCT NCT04971408)
NCT ID: NCT04971408
Last Updated: 2026-03-06
Results Overview
Plasma concentration, which was determined using enzyme-linked immunosorbent assays.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
change from 0 weeks to 8 weeks to 16 weeks
Results posted on
2026-03-06
Participant Flow
Each enrolled participant completed a time-control phase of 8 weeks prior to the passive heating intervention.
Participant milestones
| Measure |
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"
|
|---|---|
|
Control
STARTED
|
10
|
|
Control
COMPLETED
|
10
|
|
Control
NOT COMPLETED
|
0
|
|
Intervention
STARTED
|
10
|
|
Intervention
COMPLETED
|
9
|
|
Intervention
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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"
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|---|---|
|
Intervention
Event unrelated to the study
|
1
|
Baseline Characteristics
Impact of Passive Heat on Metabolic, Inflammatory and Vascular Health in Persons With Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
Participants with spinal cord injury
|
|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 14 • n=41 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=41 Participants
|
|
Years since injury
|
9.2 years
STANDARD_DEVIATION 10.5 • n=41 Participants
|
|
BMI in kg/m2
|
28.0 kg/m2
STANDARD_DEVIATION 3.0 • n=41 Participants
|
PRIMARY outcome
Timeframe: change from 0 weeks to 8 weeks to 16 weeksPlasma concentration, which was determined using enzyme-linked immunosorbent assays.
Outcome measures
| Measure |
Passive Heating Intervention (Preceded by a Time-control Phase)
n=10 Participants
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"
|
|---|---|
|
Interleukin-6
Baseline
|
6.17 pg/ml
Standard Deviation 4.72
|
|
Interleukin-6
Control
|
5.30 pg/ml
Standard Deviation 3.94
|
|
Interleukin-6
Intervention
|
6.41 pg/ml
Standard Deviation 3.98
|
SECONDARY outcome
Timeframe: change from 0 weeks to 8 weeks to 16 weeksCutaneous 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).
Outcome measures
| Measure |
Passive Heating Intervention (Preceded by a Time-control Phase)
n=10 Participants
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"
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|---|---|
|
Maximal Cutaneous Vascular Conductance
Baseline
|
2270 % of maximum conductance from 34C
Standard Deviation 714
|
|
Maximal Cutaneous Vascular Conductance
Control
|
1614 % of maximum conductance from 34C
Standard Deviation 818
|
|
Maximal Cutaneous Vascular Conductance
Intervention
|
1734 % of maximum conductance from 34C
Standard Deviation 1525
|
SECONDARY outcome
Timeframe: change from 0 to 8 to 16 weeksglucose AUC from 3h oral glucose tolerance test
Outcome measures
| Measure |
Passive Heating Intervention (Preceded by a Time-control Phase)
n=10 Participants
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"
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|---|---|
|
Glucose Tolerance
Baseline
|
7540 mg/l * 180 min
Standard Deviation 4596
|
|
Glucose Tolerance
Control
|
7410 mg/l * 180 min
Standard Deviation 688
|
|
Glucose Tolerance
Intervention
|
8253 mg/l * 180 min
Standard Deviation 2139
|
SECONDARY outcome
Timeframe: change from 0 to 8 to 16 weeksplasma concentration
Outcome measures
| Measure |
Passive Heating Intervention (Preceded by a Time-control Phase)
n=10 Participants
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"
|
|---|---|
|
TNF-alpha
Baseline
|
1.26 pg/ml
Standard Deviation 0.53
|
|
TNF-alpha
Control
|
1.03 pg/ml
Standard Deviation 0.35
|
|
TNF-alpha
Intervention
|
1.01 pg/ml
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: change from 0 to 8 to 16 weeksplasma concentration
Outcome measures
| Measure |
Passive Heating Intervention (Preceded by a Time-control Phase)
n=10 Participants
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"
|
|---|---|
|
Interleukin-1ra
Baseline
|
824 pg/ml
Standard Deviation 374
|
|
Interleukin-1ra
Control
|
798 pg/ml
Standard Deviation 298
|
|
Interleukin-1ra
Intervention
|
710 pg/ml
Standard Deviation 312
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from 0 to 8 to 16 weeksMental 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.
Outcome measures
| Measure |
Passive Heating Intervention (Preceded by a Time-control Phase)
n=10 Participants
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"
|
|---|---|
|
5-item Mental Health Inventory
Baseline
|
60.8 units on a scale
Standard Deviation 6.2
|
|
5-item Mental Health Inventory
Control
|
59.4 units on a scale
Standard Deviation 3.3
|
|
5-item Mental Health Inventory
Intervention
|
59.6 units on a scale
Standard Deviation 3.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from 0 weeks to 8 weeks to 16 weeksPerceived 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.
Outcome measures
| Measure |
Passive Heating Intervention (Preceded by a Time-control Phase)
n=10 Participants
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"
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|---|---|
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SCI Chronic Pain Survey
Control
|
2.0 units on a scale
Interval 0.0 to 3.5
|
|
SCI Chronic Pain Survey
Intervention
|
1.0 units on a scale
Interval 0.0 to 4.5
|
|
SCI Chronic Pain Survey
Baseline
|
3.0 units on a scale
Interval 0.0 to 5.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from 0 to 8 to 16 weeksThe 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.
Outcome measures
| Measure |
Passive Heating Intervention (Preceded by a Time-control Phase)
n=10 Participants
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"
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|---|---|
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Daytime Sleepiness
Baseline
|
7.9 units on a scale
Standard Deviation 5.9
|
|
Daytime Sleepiness
Control
|
7.3 units on a scale
Standard Deviation 4.6
|
|
Daytime Sleepiness
Intervention
|
8.7 units on a scale
Standard Deviation 5.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Passive Heating Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=10 participants at risk
There were no adverse events; all participants completed this study phase
|
Passive Heating Intervention
n=10 participants at risk
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.
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|---|---|---|
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Skin and subcutaneous tissue disorders
Adverse events unrelated to the intervention
|
0.00%
0/10 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
Additional Information
Dr. Michelle Trbovich, MD
South Texas Veteran's Health Care System
Phone: 2106175300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place