ClothingNCT04317027
Physiological Examination of New Fighting Clothing During Exposure to Exercise Under Hot Conditions
A study testing New Fighting Clothing in people with Clothing, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The use of fighting clothing under extreme heat conditions during rest and exercise, compromises the body's ability to maintain temperature within the narrow physiological range needed for regular function, and might lead to heat injury. Read more about this study
- Who is it for?
- Ages 20 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clothing
- What is being tested?
- New Fighting Clothing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2020to Jun 2021
- Phase
- Interventional
- 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 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men
- Formerly fighters
- Healthy
- Without prior diseases including heart, vessel, respiratory and metabolic diseases or known use of medications
- experience in using fighting clothing
- VO2max > 50 ml/kg/min
Who cannot join
- Incapacity to fulfill inclusion criteria
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Ramat Gan, Ha'Merkaz, 5262000
Sagi Shpizer, MD, +972523439957, SagiArie.Shpizer@sheba.health.gov.il
About this study
The use of fighting clothing under extreme heat conditions during rest and exercise, compromises the body's ability to maintain temperature within the narrow physiological range needed for regular function, and might lead to heat injury. Beside working and fighting clothing, the fighters also wear vests used for protection and equipment carrying, which leads to substantial reduction in effective dissipation area from the central region of the body. This fact is most substantial during exercise which increases metabolic heat production rate and leads to heat accumulation and rise in body temperature. Therefore the development of new textile technologies to allow rapid cooling during intervals is of great importance.
This study is designed to physiologically examine new textile solutions, by evaluating the physiological stress induced during exercise under mild heat conditions.
- Conditions
- Clothing
- Being tested
- New Fighting Clothing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Fighting ClothingDevice
VO2max test Clothing examination- 2-hour walk in 6 kph/4% elevation under 30 degrees Celsius and 60% relative humidity
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | All subjects in this trial will receive the new fighting clothing while performing the study protocol Receives: Device: New Fighting Clothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
Using rectal thermometer
Measured: During intervention period (2 hours test) only
Heart rate
Using heart rate watch
Measured: During intervention period (2 hours test) only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClothingStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Medical Corps, Israel Defense Force
- Responsible party
- Principal investigator, Dr. Sagi Arie Shpizer, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317027
- Sponsor's protocol ID
- SHEBA-19-6652-SS-CTIL
- Other IDs
- 2017-2019-IDF
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Examination of New Fighting Clothing During Exposure to Exercise Under Hot Conditions
- ClinicalTrials.gov ID
- NCT04317027
- Acronym / sponsor ID
- SHEBA-19-6652-SS-CTIL
- Conditions
- Clothing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Medical Corps, Israel Defense Force
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 20 Mar 2020 (actual)
- 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 use of fighting clothing under extreme heat conditions during rest and exercise, compromises the body's ability to maintain temperature within the narrow physiological range needed for regular function, and might lead to heat injury. Beside working and fighting clothing, the fighters also wear vests used for protection and equipment carrying, which leads to substantial reduction in effective dissipation area from the central region of the body. This fact is most substantial during exercise which increases metabolic heat production rate and leads to heat accumulation and rise in body temperature. Therefore the development of new textile technologies to allow rapid cooling during intervals is of great importance.
This study is designed to physiologically examine new textile solutions, by evaluating the physiological stress induced during exercise under mild heat conditions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Device: New Fighting ClothingAll subjects in this trial will receive the new fighting clothing while performing the study protocol |
Who may qualify
- Ages
- 20 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men
- Formerly fighters
- Healthy
- Without prior diseases including heart, vessel, respiratory and metabolic diseases or known use of medications
- experience in using fighting clothing
Key exclusion criteria (1 listed)
- Incapacity to fulfill inclusion criteria
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 |
|---|---|---|
| New Fighting ClothingVO2max test Clothing examination- 2-hour walk in 6 kph/4% elevation under 30 degrees Celsius and 60% relative humidity | Device | All subjects |
Primary outcome
Body temperature
Time frame: During intervention period (2 hours test) only
Using rectal thermometer
Heart rate
Time frame: During intervention period (2 hours test) only
Using heart rate watch
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Fighting Clothing in people with Clothing, run by Sheba Medical Center 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?
The sponsor lists 6 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: status not confirmed, as of the sponsor's last update on 20 Mar 2020. 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 Sagi Shpizer, MD (+972523439957, SagiArie.Shpizer@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: During intervention period (2 hours test) only). The study lists 2 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 20 Mar 2020.