N/A
N=21
Body Temperature in Persons With Tetraplegia When Exposed to Heat
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT01890915 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Mar 2016
Primary outcome: Primary: Core Body Temperature — 2.04; -0.05 Percent Change — p=0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Heat Exposure (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- James J. Peters Veterans Affairs Medical Center
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Core Body Temperature |
2.04; -0.05 | 0.0001 sig |
| SECONDARY Cognitive Performance - Stroop Interference T-Scores |
8.3; 0.3 | 0.006 sig |
Summary
The deleterious effects of hyperthermia are well appreciated in able-bodied persons. However, the consequences of impaired regulation of normal body temperature on cognitive performance of persons with tetraplegia is not known. This study will provide the preliminary findings necessary for future work to design and explore physical and medical interventions to improve temperature regulation in those with tetraplegia with the goal of improved clinical care, health, and quality of life.
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
Eligibility Criteria
Inclusion Criteria
- Between 18 and 65 years of age;
- Duration of injury ≥ 1 year;
- Level of SCI C4-T1;
- 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
- Age (± 5 years) and gender matched AB control group.
Exclusion Criteria
- Known heart and/or blood vessel disease;
- High blood pressure;
- Kidney disease;
- Diabetes mellitus;
- Acute illness or infection;
- Dehydration;
- Pregnant women;
- Untreated thyroid disease, and
- Broken, inflamed, or otherwise fragile skin.
Data sourced from ClinicalTrials.gov (NCT01890915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.