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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-SC240010 | Other Grant/Funding Number | Congressionally Directed Medical Research Programs (CDMRP) |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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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.
The experimental arm (HEAT) participants undergo an 8-week intervention with 4 weekly passive heat therapy sessions. The aim of each session is to raise the participants' core temperature by at least 1°C by resting under heating blankets set at approximately 42°C. The control arm (SHAM) participants undergo the same procedure as above except the temperature setting of the blankets is lower at approximately 34°C.
Screening, baseline assessments and the first 4 sessions will be conducted in the investigator's SCI lab to familiarize the participant with how to apply the heating blankets and ensure safety. After the 4th session, participants will receive a heating blanket for use at home in the remaining 7 intervention weeks. Cardiac MRI and peripheral vascular assessments are performed at baseline and within two weeks after completing the intervention. Weekly sessions (4x per week) in weeks 2 to 8 will be performed at home and secure VA-approved online video conferencing software will be used by study staff to remotely supervise the sessions and collect data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEAT | Experimental | The experimental arm (HEAT) participants undergo an 8-week intervention with 4 weekly passive heat therapy sessions (home based for 7 of 8 weeks) using an electrical heating blanket at a temperature of 42 degrees C. |
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| SHAM | Sham Comparator | For participants in SHAM, the heating blankets will be warm (~34°C) but will not reach a temperature that elevates core temperature. As in the HEAT arm, sessions will be home based for 7 of 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEAT - Passive Heat Therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Laser Doppler Flowmetry (LDF) | Measure of skin blood flow due to local skin heating | From baseline to end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Peripheral Arterial Tone (EndoPAT) | Measures the changes in finger pulsatile arterial volume | Baseline to end of treatment at 8 weeks |
| Venous Occlusion Plethysmography (VOP) | Limb blood flow measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Trbovich, MD | Contact | 210-617-5300 | 16986 | michelle.trbovich@va.gov |
| Dean L Kellogg, Jr, MD, PhD | Contact | 210-617-5300 | kelloggd@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Trbovich, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Audie L Murphy Veterans Memorial Hospital, South Texas Veterans Health Care System | Recruiting | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D000084462 | Hyperthermia |
| D018882 | Heat Stress Disorders |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Sham (No Treatment) | Other | 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. |
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| From baseline to end of treatment at 8 weeks |
| Cardiac MRI | Measures stiffness of the aorta | Baseline to end of treatment at 8 weeks |
| D014947 | Wounds and Injuries |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |