NCT00349804

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

July 5, 2006

Last Update Submit

March 9, 2012

Conditions

Body Temperature Regulation

Keywords

temperatureTemperature Homeostasis

Outcome Measures

Primary Outcomes (5)

  • Heart rate

    (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))

Secondary Outcomes (3)

  • Fluid intake during trials

    Post measurement (total consumed)

  • Urine color

    (pre and post)

  • Specific gravity

    (pre and post)

Study Arms (1)

Air cooled (COOL)

OTHER

Subjects will complete the intermitent exercise protocol with cool dry air blown under the shoulder pads during the rest periods and recovery session

Other: cool dry air

Interventions

cool dry airOTHER

cool dry air (0.22-0.28 m3/min at 15-18 Degrees C)

Air cooled (COOL)

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males
  • ages 18-30 years

You may not qualify if:

  • a health questionnaire to identify any contraindications will be given during screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Study Officials

  • MaryBeth Horodyski, EdD, ATC

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 10, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 12, 2012

Record last verified: 2012-03

Locations

US(1)