Physiological StressNCT02641535
Evaluating the Physiological Strain Induced by a BC Membrane Protective Garment Under Exercise-heat Stress Compared to a Protective Coverall
A study testing exercise under hot and humid conditions protocol, BC membrane protective garment and NBC mask in people with Physiological Stress, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Israel ministry of defense is examining a new BC membrane protective garment of BLAUER company constructed with GORE CHEMPAK fabric for the border guard of the police forces. The goal of this research is to perform a comparative experiment in order to evaluate the physiological strain induced by the new protective… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress
- What is being tested?
- exercise under hot and humid conditions protocol, BC membrane protective garment and NBC mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2016to Feb 2017
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-40 years.
- Healthy civilian volunteers.
- Without known medical illness or medication use.
Who cannot join
- The existence or suspicion of existing cardiac or respiratory disease.
- Hypertension.
- Diabetes.
- Psychiatric condition.
- Any muscles or skeleton condition.
- Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
- Infectious disease 3 days prior to the experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Israel ministry of defense is examining a new BC membrane protective garment of BLAUER company constructed with GORE CHEMPAK fabric for the border guard of the police forces. The goal of this research is to perform a comparative experiment in order to evaluate the physiological strain induced by the new protective garment under exercise-heat stress conditions, compared to protective garment in current use.
Read the detailed description
In order to physiologically evaluate a new BC membrane protective garment for the Israeli police use under exercise-heat stress conditions, 12 healthy volunteers from the border guard will participate in this study.
The subjects will undergo 4 experiment days: Recruitment day, one day of acclimatization to heat, and 2 days of performing experiment protocol, each day dressed with different protective garment (Protective garment in current use + NBC mask, new BC membrane protective garment + NBC mask).
Core (rectal) and skin temperature and heart rate will be monitored continuously, liquid balance will be recorded.the physiological heat strain will be assessed and compared between the different protective garments.
- Conditions
- Physiological Stress
- Being tested
- exercise under hot and humid conditions protocol, BC membrane protective garment, NBC mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise under hot and humid conditions protocolOther
acclimatization day protocol: 2 hour effort performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (40 deg. centigrade \& 40% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously
experiment days (2 days): 2 hour effort (2 cycles of: 50 min walk and 10 min rest-sitting) performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (35 deg. centigrade \& 60% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously.
BC membrane protective garmentDevice
NBC maskDevice
| Study group | Role | What they receive |
|---|---|---|
| research arm | Experimental | 12 healthy volunteers from the border guard of the police forces will participate in this study. The subjects will undergo 4 experiment days:
1. Recruitment , medical examination and VO2max test.
2. Acclimatization day by performing moderate exercise protocol under hot and humid climate.
3.2 days of performing moderate exercise under hot and humid conditions protocol, each day dressed with different protective garment:
1. Protective garment in current use + NBC mask.
2. The new BC membrane protective garment + NBC mask Receives: Other: exercise under hot and humid conditions protocol; Device: BC membrane protective garment; Device: NBC mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological strain (composite)
The physiological strain will be determined by body core temperature and heart rate of the subjects during experiment days with protocol of exercise under heat stress conditions.
Measured: 3 days for each participant
Secondary outcomes (4)
Rectal temperature
The rectal temperature will be monitored by a rectal thermistor (YSI-401) inserted 10 cm past the anal sphincter.
Measured: 3 days for each participant
Skin temperature
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
Measured: 3 days for each participant
Heart rate
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Measured: 4 days for each participant
Sweat rate (composite)
Sweat rate will be calculated from the patients' body weight and fluid balance.
Measured: 3 days for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological StressStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ofir Frenkel, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641535
- Sponsor's protocol ID
- SHEBA-15-2689-OF-CTIL
- Status last verified
- Dec 2015
- First submitted
- 23 Dec 2015
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Physiological Strain Induced by a BC Membrane Protective Garment Under Exercise-heat Stress Compared to a Protective Coverall
- ClinicalTrials.gov ID
- NCT02641535
- Acronym / sponsor ID
- SHEBA-15-2689-OF-CTIL
- Conditions
- Physiological Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 29 Dec 2015 (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.
Israel ministry of defense is examining a new BC membrane protective garment of BLAUER company constructed with GORE CHEMPAK fabric for the border guard of the police forces. The goal of this research is to perform a comparative experiment in order to evaluate the physiological strain induced by the new protective garment under exercise-heat stress conditions, compared to protective garment in current use.
Detailed description
In order to physiologically evaluate a new BC membrane protective garment for the Israeli police use under exercise-heat stress conditions, 12 healthy volunteers from the border guard will participate in this study.
The subjects will undergo 4 experiment days: Recruitment day, one day of acclimatization to heat, and 2 days of performing experiment protocol, each day dressed with different protective garment (Protective garment in current use + NBC mask, new BC membrane protective garment + NBC mask).
Core (rectal) and skin temperature and heart rate will be monitored continuously, liquid balance will be recorded.the physiological heat strain will be assessed and compared between the different protective garments.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| research arm | Experimental | Other: exercise under hot and humid conditions protocol, Device: BC membrane protective garment, Device: NBC mask12 healthy volunteers from the border guard of the police forces will participate in this study. The subjects will undergo 4 experiment days: 1. Recruitment , medical examination and VO2max test. 2. Acclimatization day by performing moderate exercise protocol under hot and humid climate. 3.2 days of performing moderate exercise under hot and humid conditions protocol, each day dressed with different protective garment: 1. Protective garment in current use + NBC mask. 2. The new BC membrane protective garment + NBC mask |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-40 years.
- Healthy civilian volunteers.
- Without known medical illness or medication use.
Key exclusion criteria (7 listed)
- The existence or suspicion of existing cardiac or respiratory disease.
- Hypertension.
- Diabetes.
- Psychiatric condition.
- Any muscles or skeleton condition.
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 |
|---|---|---|
| exercise under hot and humid conditions protocolacclimatization day protocol: 2 hour effort performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (40 deg. centigrade \& 40% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously experiment days (2 days): 2 hour effort (2 cycles of: 50 min walk and 10 min rest-sitting) performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (35 deg. centigrade \& 60% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously. | Other | research arm |
| BC membrane protective garment | Device | research arm |
| NBC mask | Device | research arm |
Primary outcome
physiological strain (composite)
Time frame: 3 days for each participant
The physiological strain will be determined by body core temperature and heart rate of the subjects during experiment days with protocol of exercise under heat stress conditions.
4 secondary outcomes
Rectal temperature
Time frame: 3 days for each participant
Skin temperature
Time frame: 3 days for each participant
Heart rate
Time frame: 4 days for each participant
Sweat rate (composite)
Time frame: 3 days for each participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
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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.
Ofir Frenkel, M.D principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise under hot and humid conditions protocol, BC membrane protective garment and NBC mask in people with Physiological Stress, 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 3 inclusion and 7 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 29 Dec 2015. 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 Ofir Frenkel, M.D (+972529243399, Ofir.Frenkel@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological strain (composite) (time frame: 3 days for each participant). 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 29 Dec 2015.