Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Intermittent Cold and Dry Air Underneath Football Shoulder Pads
This study has been completed.
Sponsors and Collaborators: University of Florida
NFL Charities
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00349804
  Purpose

The purpose of this study is to test if temperature homeostasis in football players can be improved by circulating cool, dry air underneath shoulder pads between periods of intense physical activity.


Condition Intervention Phase
Body Temperature Regulation
Device: Air-Cooled Shoulder Pads
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Intermittent Cold and Dry Air Underneath Football Shoulder Pads as a Method to Assist in Temperature Homeostasis: Evaluation of Efficacy

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • DURING TESTING (min 0- 75)
  • Ambient temperature (baseline and every 5 minutes)
  • Humidity (baseline and every 5 minutes)
  • Heat index (baseline and every 5 minutes)
  • Core body temperature (baseline, min 25, min 50 and post (min 75))
  • Heart rate (baseline, min 25, min 50 and post (min 75))
  • Skin temperature (baseline, min 25, min 50 and post (min 75))
  • Infrared body temperature (baseline, min 25, min 50 and post (min 75))
  • Physiological strain index (PSI) (baseline, min 25, min 50 and post (min 75))
  • Visual analog thirst scale (VATS) (baseline, min 25, min 50 and post (min 75))
  • Rate of perceived exertion (RPE) (baseline, min 25, min 50 and post (min 75))
  • Thermal sensation scale (TSS) (baseline, min 25, min 50 and post (min 75))
  • DURING RECOVERY PERIOD (min 75 - 115)
  • Core body temperature (recorded every 30 seconds)
  • Skin temperature (recorded every 30 seconds)
  • Heart rate (recorded every 30 seconds)
  • Infrared images (every 2 minutes)
  • PSI, VATS, RPE, and TSS (every 5 minutes)

Secondary Outcome Measures:
  • Fluid intake between 0900 and 2100 on days before trials (30 ml/kg body mass)
  • Fluid intake during trials
  • Time ingestible temperature sensor is swallowed
  • Urine color (pre and post)
  • Specific gravity (pre and post)
  • Height
  • Body mass (pre and post)
  • Skinfold measurements
  • Percent body fat
  • Body sweating rate

Estimated Enrollment: 25
Study Start Date: June 2006
Detailed Description:

The purpose of this study is to test if temperature homeostasis in football players can be improved by circulating cool, dry air underneath shoulder pads between periods of intense physical activity. To assess the efficacy of this intervention, several dependent variables will be tested: core body temperature, skin temperature, infrared skin temperature, heart rate, sweating rate, urine color, urine specific gravity, physiological strain index, visual analog thirst, rate of perceived exertion, thermal sensation scale, and fluid intake. The two independent variables (test variables) are treatment which has two levels (Control - no air blown under the shoulder pads, COOL - cool, dry air blown under the shoulder pads) and time (pre-exercise and post-exercise cycles, rest break and recovery).

Specific Aim 1: To assess differences in physiological parameters when cooled dry air is blown under football shoulder pads as a means of cooling football players between periods of exercise and after exercise. Limited research is available to demonstrate the efficacy of cooling methods alternated with vigorous exercise. Football players are at particular risk for heat-related illness because they frequently practice and compete in hot, humid conditions in uniforms that limit the body's natural thermoregulation. To study this specific aim, three hypotheses will be addressed during the data collection process of this investigation: (1) a significantly lower increase in core body temperature, heart rate, skin temperature, and infrared skin temperature will be noted during the COOL testing sessions as compared to the Control sessions; (2) significantly lower measurements of urine color, urine specific gravity, and sweat rate will be noted in the COOL testing sessions as compared to the Control sessions; and (3) significant associations will be noted between core body temperature and infrared temperature during both testing sessions.

Specific Aim 2: To assess differences in subjective ratings of exertion and heat stress during and after exercise sessions when cooled dry air is blown under football shoulder pads as compared to no air during rest breaks between the exercise bouts. The rationale behind Specific Aim 2 is that the cooling method (COOL) will aid in improving the body's blunted cooling mechanisms. The sensation of the cool, dry air will be more prominent than the sensation of warmth (during the COOL trials), the decrease in physiological strain, and the decrease in core body temperature will cause the subject to experience lower perceived exertion; thus, subjects' subjective response to exertion in subsequent exercise cycles will be decreased. One hypothesis will be addressed related to this specific aim: cool, dry air blown under football shoulder pads (COOL) as a cooling method between exercise bouts will significantly lower physiological strain index score, visual analog thirst score, rate of perceived exertion, and thermal sensation score as compared to no cool, dry air being blown under the shoulder pads (Control).

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy males
  • ages 18-30 years

Exclusion Criteria:

  • a health questionnaire to identify any contraindications will be given during screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349804

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
NFL Charities
Investigators
Principal Investigator: MaryBeth Horodyski, EdD, ATC University of Florida
  More Information

Study ID Numbers: 111-2006
Study First Received: July 5, 2006
Last Updated: May 19, 2008
ClinicalTrials.gov Identifier: NCT00349804  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
temperature
Temperature Homeostasis

ClinicalTrials.gov processed this record on January 14, 2009