Body Temperature RegulationPhase 3NCT00349804
Intermittent Cold and Dry Air Underneath Football Shoulder Pads
A Phase 3 study testing cool dry air in people with Body Temperature Regulation, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Regulation
- What is being tested?
- cool dry air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males
- ages 18-30 years
Who cannot join
- a health questionnaire to identify any contraindications will be given during screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Cold and Dry Air Underneath Football Shoulder Pads as a Method to Assist in Temperature Homeostasis: Evaluation of Efficacy
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.
Read the 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).
- Conditions
- Body Temperature Regulation
- Being tested
- cool dry air
- Keywords
- temperature, Temperature Homeostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cool dry airOther
cool dry air (0.22-0.28 m3/min at 15-18 Degrees C)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: cool dry air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Measured: (baseline, min 25, min 50 and post (min 75))
Physiological strain index (PSI)
Measured: (baseline, min 25, min 50 and post (min 75))
Visual analog thirst scale (VATS)
Measured: (baseline, min 25, min 50 and post (min 75))
Rate of perceived exertion (RPE)
Measured: (baseline, min 25, min 50 and post (min 75))
Thermal sensation scale (TSS)
Measured: (baseline, min 25, min 50 and post (min 75))
Secondary outcomes (3)
Fluid intake during trials
Measured: Post measurement (total consumed)
Urine color
Measured: (pre and post)
Specific gravity
Measured: (pre and post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature RegulationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- NFL Charities
- Responsible party
- Sponsor
- Investigators
- MaryBeth Horodyski, EdD, ATC, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349804
- Sponsor's protocol ID
- 111-2006
- Status last verified
- Mar 2012
- First submitted
- 5 Jul 2006
- Last updated
- 12 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Cold and Dry Air Underneath Football Shoulder Pads as a Method to Assist in Temperature Homeostasis: Evaluation of Efficacy
- ClinicalTrials.gov ID
- NCT00349804
- Acronym / sponsor ID
- 111-2006
- Conditions
- Body Temperature Regulation
- Keywords
- temperature, Temperature Homeostasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- NFL Charities
- Study start
- Jun 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Air cooled (COOL) | Other | Other: cool dry airSubjects will complete the intermitent exercise protocol with cool dry air blown under the shoulder pads during the rest periods and recovery session |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy males
- ages 18-30 years
Key exclusion criteria (1 listed)
- a health questionnaire to identify any contraindications will be given during screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cool dry aircool dry air (0.22-0.28 m3/min at 15-18 Degrees C) | Other | Air cooled (COOL) |
Primary outcome
Heart rate
Time frame: (baseline, min 25, min 50 and post (min 75))
Physiological strain index (PSI)
Time frame: (baseline, min 25, min 50 and post (min 75))
Visual analog thirst scale (VATS)
Time frame: (baseline, min 25, min 50 and post (min 75))
Rate of perceived exertion (RPE)
Time frame: (baseline, min 25, min 50 and post (min 75))
Thermal sensation scale (TSS)
Time frame: (baseline, min 25, min 50 and post (min 75))
3 secondary outcomes
Fluid intake during trials
Time frame: Post measurement (total consumed)
Urine color
Time frame: (pre and post)
Specific gravity
Time frame: (pre and post)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MaryBeth Horodyski, EdD, ATC principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cool dry air in people with Body Temperature Regulation, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: (baseline, min 25, min 50 and post (min 75))). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2012.