Trial record 13 of 18 for:    Open Studies | "Sweat"

Body Temperature in Persons With Tetraplegia When Exposed to Heat

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by James J. Peters Veterans Affairs Medical Center
Sponsor:
Information provided by (Responsible Party):
John Handrakis, PT, DPT, EdD, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01890915
First received: June 27, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

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


Condition Intervention
Spinal Cord Injury
Other: Heat Exposure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Core Temperature During Heat Exposure in Persons With Tetraplegia

Resource links provided by NLM:


Further study details as provided by James J. Peters Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Core body temperature [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    To determine the change in core body temperature in the seated position from 79 degrees F for 30 minutes to 95 degrees F for up to 2 hours. Hypotheses: Persons with tetraplegia will have a greater increase in core body temperature than able-bodied (AB) control subjects. Core body temperature in AB persons will be maintained.


Secondary Outcome Measures:
  • Cognitive performance [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    To determine the change in cognitive performance as measured by attention, working memory, processing speed, and executive function, measured after 30 min at 79 degrees F and after up to 2 hours at 95 degrees F. Hypothesis: Persons with tetraplegia compared with AB will have a greater change in cognitive performance.


Other Outcome Measures:
  • Sweat rate [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    To determine the change in sweat rate from 30 minutes at 79 degrees F compared to after up to 2 hours at 95 degrees F. Hypothesis: Persons with tetraplegia compared with AB will have less of a percent change in average sweat rate.


Biospecimen Retention:   Samples With DNA

Venous blood samples


Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tetraplegia
Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.
Other: Heat Exposure
Heat exposure of 95 degrees F for up to 2 hours.
Other Name: 95 degrees F for up to 2 hours.
Control
Age and gender-matched able-bodied controls. Ages 18-65 years old.
Other: Heat Exposure
Heat exposure of 95 degrees F for up to 2 hours.
Other Name: 95 degrees F for up to 2 hours.

Detailed Description:

After a cervical spinal cord injury (SCI) the motor, sensory and autonomic deficits cause, among other detriments, a blunted ability to maintain a constant core temperature. Impaired thermoregulation leaves persons with tetraplegia more susceptible to hyperthermia than able-bodied persons (AB). There has been a paucity of work addressing the thermoregulatory responses of persons with SCI to hot ambient temperatures, and even less study addressing the effect of these temperatures on cognitive performance. The goals of this pilot study are: to improve our understanding of the thermoregulatory mechanisms of individuals with tetraplegia when exposed to heat and to determine the effect of impaired thermoregulatory mechanisms on cognitive performance during exposure to 35°C for up to 2 hours. In order to address our goals we have designed a study methodology which consists of comparing the physiological and psychological responses of the two study groups (tetraplegia versus AB controls) from thermoneutral (27°C) to hot (35°C) environments.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

10 subjects with tetraplegia (SCI, C4-T1), ages 18-65 years old and 10 age- and gender-matched, able-bodied controls will be accepted for participation.

Criteria

Inclusion Criteria:

  1. Between 18 and 65 years of age;
  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:

  1. Known heart and/or blood vessel disease;
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890915

Contacts
Contact: John P Handrakis, PT, DPT, EdD 718 584-9000 ext 5439 john.handrakis@va.gov
Contact: Kirsten Swonger, BS 718 584-9000 ext 3130 kirsten.swonger@va.gov

Locations
United States, New York
Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC Recruiting
Bronx, New York, United States, 10468
Contact: John P Handrakis, PT, DPT, EdD    718-584-9000 ext 5439    john.handrakis@va.gov   
Contact: Kirsten Swonger, BS    718 584-9000 ext 3130    kirsten.swonger@va.gov   
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Investigators
Principal Investigator: John P Handrakis, PT, DPT, EdD Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC
  More Information

No publications provided

Responsible Party: John Handrakis, PT, DPT, EdD, Research Health Science Specialist, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01890915     History of Changes
Other Study ID Numbers: HAN-12-04
Study First Received: June 27, 2013
Last Updated: June 27, 2013
Health Authority: United States: Federal Government

Keywords provided by James J. Peters Veterans Affairs Medical Center:
Spinal cord injury
Body temperature
Executive function
Sweat

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014