NCT01954537

Brief Summary

To collect field data in professional, collegiate, and high school football players to determine how they respond physiologically to the rigors of preseason training environment. Investigators will compare core temperature, hydration status, practice guidelines regarding rest and hydration, and baseline knowledge of heat illness and hydration among the three levels. The hypothesis is higher peak temperatures will be observed in the younger less experienced football players.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

1 month

First QC Date

September 18, 2013

Last Update Submit

September 26, 2013

Conditions

Keywords

Exertional heat illnessHydration StatusPreseason footballheat stroke

Outcome Measures

Primary Outcomes (1)

  • Peak core body temperature

    Measured via HQInc ingestible core thermometer throughout practices.

    The first 3-4 days of preseason football practice for each cohort.

Secondary Outcomes (2)

  • Hydration status before and after preseason football practice

    Over first 3-4 days of each cohort's preseason camp.

  • Baseline knowledge of hydration status and heat illness in football

    Up to August 30th, 2013

Study Arms (3)

Professional football players

Offensive and defensive professional football players ranging in age from 22 to 30 years old.

Collegiate Football Players

Division III collegiate football players ranging in age from 20 to 23 years old.

High School Football Players

High school football players ranging in age from 16 to 18 years old.

Eligibility Criteria

Age14 Years+
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be volunteers from the Minnesota Vikings Professional football team, Bethel University Division III football team, and Roseville High School football team.

You may qualify if:

  • Football player on one of the teams from the pre-selected teams. Male.

You may not qualify if:

  • Any athlete weighing less than eighty (80) pounds.
  • Any athlete with any known or suspected diseases of the gastrointestinal tract.
  • Any athlete with impairment of the gag reflex.
  • Any athlete with previous gastrointestinal surgery.
  • Any athlete with history of problems with their esophagus.
  • Any athlete who might undergo an MRI scan before the temperature sensor has been eliminated from the body.
  • Any athlete with problems moving food through their gastrointestinal tract.
  • Any athlete having a cardiac pacemaker or other implanted electro medical device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heat Stress DisordersHeat Stroke

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Austin R Krohn, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2013

First Posted

October 1, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 1, 2013

Record last verified: 2013-09