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.
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
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:
- The physiological differences between men and women
- 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 group | Role | What they receive |
|---|---|---|
| group 1 | young women not using OC | |
| group 2 | young women using OC | |
| group 3 | young men (database) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Rectal temperature
The rectal temperature will be mesured by a rectal thermistore.
Measured: 1 year
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
Heart rate
The heart rate will be mesured by a polar watch.
Measured: 1 year
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.
- First posted14 Oct 2010 (estimated)
- Study startFeb 2011
- Primary completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat ToleranceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Investigators
- Amit Druyan, MD, Principal investigator, International Diabetes Federation
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study for Standardization of Heat Tolerance Test for Young Women
- ClinicalTrials.gov ID
- NCT01221038
- Acronym / sponsor ID
- 923-2010-CTIL
- Conditions
- Heat Tolerance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (estimated)
- First posted
- 14 Oct 2010 (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.
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:
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:
- The physiological differences between men and women
- 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.
Study design
- Observational model
- Case-control
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –young women not using OC |
| group 2 | – | –young women using OC |
| group 3 | – | –young men (database) |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- young health women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The physiological load in women
Time frame: 1 year
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.
4 secondary outcomes
Rectal temperature
Time frame: 1 year
Skin temperature
Time frame: 1 year
Heart rate
Time frame: 1 year
Sweat rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2011.
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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.
Amit Druyan, M.D contact
Amit Druyan, MD principal investigator
International Diabetes Federation
1 site in 1 country: see every site and its status.
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.