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Heat ToleranceNCT01221038

Standardization of a Heat Tolerance Test for Young Women as a Basis for Heat Tolerance Tests in Female Soldiers

An observational study of Heat Tolerance, run by Medical Corps, Israel Defense Force at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: Heat stroke is defined as a condition where the body temperature raises to dangerous level that may cause harm to body tissues and lead to multi-system clinical and pathological manifestations that might lead to death. Among heat stroke survivors a defect in thermoregulation develops as a consequence. Read more about this study

Who is it for?
Ages 20 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Heat Tolerance
How many people
30 participants
Where
1 siteIsrael
Study dates
Feb 2011to Nov 2011
Phase
Observational
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 20 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: young health women

Inclusion Criteria:age 20-30 year, no past medical history, BMI 20-29, physically active, after completion of medical questionnaire and physical examination -

Exclusion Criteria:heart diseases, respiratory diseases,resting BP>140/90, DM, anhydrosis, skin diseases, pregnancy, breast feeding, using OC continuously, acute illness in the past two weeks.

-

Trial locations and contacts

1 site in 1 country.

Amit Druyan, M.D contact

Amit.Druyan@sheba.health.gov.il

Israel1 site, 1 recruiting
  • Sheba medical center

    Ramat Gan

    Recruiting

Other trials in Israel

About this study

Official title: Preliminary Study for Standardization of Heat Tolerance Test for Young Women

Background:

Heat stroke is defined as a condition where the body temperature raises to dangerous level that may cause harm to body tissues and lead to multi-system clinical and pathological manifestations that might lead to death. Among heat stroke survivors a defect in thermoregulation develops as a consequence. In the IDF, every soldier who had a heat stroke, or is suspected to have had a heat stroke, must pass a heat intolerance test in the Unit of Military Physiology, after a rest period of 4-6 from the incident, which is the approximate period for thermoregulation to recuperate from the injury after a heat stroke. Until the heat intolerance test, the soldier must not train to avoid a repeat incident of heat stroke. The soldiers' ability to return to active duty is based on the results of the exam. The heat tolerance test and its criteria have been developed in the Physiology Unit throughout years of experience, and have been proved and adopted by several labs in Europe and in the United States. The criteria generally include baseline temperature and heart rate, and are based upon the physiological response of healthy men (soldiers) in the physical effort involved in the test.In recent years there is a growing trend in the IDF to integrate female soldiers in combat divisions. As a result, these females are exposed to physical efforts in various climate conditions as a part of their training, or a part of their active duty missions in the division. Therefore, the probability of an incidence of heat injuries increases among these soldiers.Research results indicate differences in the efficiency of thermoregulation mechanisms between men and women:

Read more

It has been found that in women the threshold for sweating and vasodilatation is higher than in males. Additionally, although in women the mechanism for sweating is slower, and occurs at a later period, it is found that the relative part of sweating that evaporates is higher, so that women evaporate sweat more efficiently (to make up for the lower sweat quantities compared to men). Reduced efficiency of the thermoregulation mechanisms in women is also attributed to the differences in mass, body composition (fat and muscle mass), and physical fitness between the genders. In addition, the physiological changes that occur during the different phases of the menstrual cycle can affect core temperature at rest and thermoregulation. Different reports in literature indicate a decreased thermoregulation capacity in the luteal phase of the menstrual cycle compared to the follicular phase. Apparently, thermoregulation capabilities in exercise are linked to progesterone blood levels, which are influenced by contraceptive pills and with the phase of the menstrual cycle.

There are two factors that can cause incorrect diagnosis of the level of heat tolerance in females when the specific test is interpreted based on set criteria for men. These criteria are:

  1. The physiological differences between men and women
  2. The differences in women based on menstrual cycle and using contraceptive pills.

Thus, there is a need to characterize and establish the normal values in a heat tolerance test for young females compared to males, and also to correspond to current menstrual cycle phase and use of contraceptive pills.

Methods:

on the first day of the research, the participants will undergo anthropometric examinations (measuring height, weight, BMI, fat content, maximum oxygen consumption). In addition, the participants will undergo a heat tolerance test protocol. The heat tolerance test will be conducted twice in every participant - once in the follicular phase of the menstrual cycle, and a second time in the luteal phase of the cycle. During the protocol, the following information will be collected from each participant: heart rate, core temperature, skin temperature in three locations (chest, arm, and leg), oxygen consumption and liquid balance.

The results of the examination will be compared to results of male participants who have previously undergone the heat tolerance test in the Unit of Military Physiology.

Contribution to IDF:

the research will allow administrating heat tolerance tests accurately and reliably to female soldiers that have been affected by heat injuries or are suspected to be heat intolerant.

Conditions
Heat Tolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01221038
Study groupRoleWhat they receive
group 1young women not using OC
group 2young women using OC
group 3young men (database)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The physiological load in women

    The physiological load will be mesured during a heat tolerance test (HTT) and will be compared to the physiological load during an HTT in men.

    Measured: 1 year

Secondary outcomes (4)
  1. Rectal temperature

    The rectal temperature will be mesured by a rectal thermistore.

    Measured: 1 year

  2. Skin temperature

    The skin temperature will be mesured during an HTT by skin thermistores conected to 3 sites (chest, leg and arm).

    Measured: 1 year

  3. Heart rate

    The heart rate will be mesured by a polar watch.

    Measured: 1 year

  4. Sweat rate

    The sweat rate will be calculeted from the subject's weight before and after the HTT and from his water balance.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionNov 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221038
Sponsor's protocol ID
923-2010-CTIL
Status last verified
Jun 2011
First submitted
13 Oct 2010
Last updated
13 Jul 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heat Tolerance, run by Medical Corps, Israel Defense Force at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 13 Jul 2011. 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 Israel. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amit Druyan, M.D (Amit.Druyan@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The physiological load in women (time frame: 1 year). 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 13 Jul 2011.

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