[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617378":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: HEAT - Passive Heat Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Sham (No Treatment)",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"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.",[15],[31],{"name":32,"affiliation":5,"role":33},"Michelle Trbovich, MD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","210-617-5300","16986","michelle.trbovich@va.gov",{"name":41,"role":36,"phone":37,"phoneExt":25,"email":42},"Dean L Kellogg, Jr, MD, PhD","kelloggd@uthscsa.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Audie L Murphy Veterans Memorial Hospital, South Texas Veterans Health Care System","RECRUITING","San Antonio","Texas","78229","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-98.49363,29.42412,{"lat":56,"lon":55},[59],{"name":60,"role":36,"phone":25,"phoneExt":25,"email":25},"Michelle Paprocki, RN",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[64],{"name":65,"class":66},"Congressionally Directed Medical Research Programs","FED","100617378","home-based-heat-therapy-in-spinal-cord-injury-to-improve-cardiovascular-health-100617378",false,"NCT07317843","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","IIS_SCIDoD","Inclusion Criteria:\n\n1. Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent.\n2. Participants will be male or female, 18-60 years of age, at the time of Visit 0.\n3. 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.\n4. Stable SCI (AIS A or B) of longer than 1-year duration.\n5. 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.\n\nExclusion Criteria:\n\n1. Participants who smoke, or:\n2. Uses daily administration of anti-inflammatory medications (stable doses of NSAIDs or statins are acceptable; steroids are exclusionary)\n3. Uses daily administration of vasoactive medications (e.g., alpha antagonists or agonists or phosphodiesterase inhibitors).\n4. Has a current pressure ulcer or skin breakdown.\n5. Has an active, uncontrolled, autoimmune or inflammatory disorder\n6. Has no history of or current alcohol or substance use disorder\n7. Has a history of heat related illness (e.g., heat stroke)\n8. 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.\n9. Is unlikely to cooperate with the requirements of the study.","ALL","18 Years","60 Years",{"count":79,"type":80},48,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.",[86],"SCI - Spinal Cord Injury",[88,89,90,91,92],"SCI","heat therapy","heat stress","passive heat","vascular function","2026-04-28",{"date":95,"type":96},"2026-05-05","ACTUAL",{"date":98,"type":96},"2026-03-24",{"date":100,"type":80},"2031-07",{"name":5,"class":6},1]