Body Temperature in Persons With Tetraplegia When Exposed to Heat
NCT ID: NCT01890915
Last Updated: 2016-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
21 participants
OBSERVATIONAL
2013-05-31
2015-10-31
Brief Summary
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The proposed study consists of 1 visit during which 20 subjects (10 with tetraplegia, 10 controls) will be exposed to 81°F for 40 minutes and then 95° F for up to 2 hours. Physiological as well as psychological processes will be monitored in all subjects during the study for safety and to determine differences in responses to exposure to hot ambient temperatures
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Tetraplegia
Persons with spinal cord injury, level of injury C4-T1, American Spinal Injury Association (ASIA) impairment levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.
Heat Exposure
Heat exposure of 95 degrees F for up to 2 hours.
Control
Age and gender-matched able-bodied controls. Ages 18-65 years old.
Heat Exposure
Heat exposure of 95 degrees F for up to 2 hours.
Interventions
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Heat Exposure
Heat exposure of 95 degrees F for up to 2 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Duration of injury ≥ 1 year;
3. Level of SCI C4-T1;
4. Euhydration (Subjects will be instructed to avoid caffeine and alcohol, maintain normal salt and water intake, and avoid strenuous exercise for 24 hours prior to study); and
5. Age (± 5 years) and gender matched AB control group.
Exclusion Criteria
2. High blood pressure;
3. Kidney disease;
4. Diabetes mellitus;
5. Acute illness or infection;
6. Dehydration;
7. Pregnant women;
8. Untreated thyroid disease, and
9. Broken, inflamed, or otherwise fragile skin.
18 Years
65 Years
ALL
Yes
Sponsors
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James J. Peters Veterans Affairs Medical Center
FED
Responsible Party
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John Handrakis, PT, DPT, EdD
Research Health Science Specialist
Principal Investigators
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John P Handrakis, PT, DPT, EdD
Role: PRINCIPAL_INVESTIGATOR
Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC
Locations
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Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC
The Bronx, New York, United States
Countries
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References
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Kumar NS, Bart J, Barton C, Graham ML, Leung PP, Tittley TD, Lee I, Bang C, Bauman WA, Handrakis JP. Core Temperature Lability Predicts Sympathetic Interruption and Cognitive Performance during Heat Exposure in Persons with Spinal Cord Injuries. J Neurotrauma. 2021 Aug 1;38(15):2141-2150. doi: 10.1089/neu.2020.7598. Epub 2021 May 26.
Handrakis JP, Ni Guan Z, Nulty JW, Tascione O, Rosado-Rivera D, White D, Bang C, Spungen AM, Bauman WA. Effect of Heat Exposure on Cognition in Persons with Tetraplegia. J Neurotrauma. 2017 Dec 15;34(24):3372-3380. doi: 10.1089/neu.2016.4850. Epub 2017 Aug 16.
Other Identifiers
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HAN-12-04
Identifier Type: -
Identifier Source: org_study_id
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