Physiological StressNCT02442947
Examination of Textile Solutions for Reducing Physiological Stress
A study testing clothing type, protective garments of Paul Boye Technologies in people with Physiological Stress, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Using protective or combat garments under heavy heat stress conditions, during rest or exertion, may hinder the body's ability to effectively exchange heat with the environment and thereby can lead to heat injuries. 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
- Physiological Stress
- What is being tested?
- clothing type, protective garments of Paul Boye Technologies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2015to Dec 2015
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-30 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 skeledon 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
Official title: Physiological Examination of Textile Solutions for Stress Reduction When Dressed in Protective Garment and Work Clothes and Under Physical and Heat Stress Conditions
Using protective or combat garments under heavy heat stress conditions, during rest or exertion, may hinder the body's ability to effectively exchange heat with the environment and thereby can lead to heat injuries. The purpose of this research is to physiologically examine the new textile solutions that are planned to be integrated in the protective garments, combat garments and work uniforms in the army, by evaluating the physiological stress obtained during exertion under hot climatic conditions.
Read the detailed description
10 young, healthy civilian volunteers will participate in this study. After reading and signing an informed consent form, all subjects will undergo medical examination which includes ECG, anthropometric measurements and Vo2max test. Afterwards, the subjects will perform 6 acclimatization days carried out by the standard protocol of Heat Tolerance Test (HTT). After acclimatization, the subjects will undergo 4 experiment days under heavy heat stress in a climatic chamber, dressed in each experiment day with one out of 4 clothing combinations (NBC protective garment [charcoal base], combat garment and 2 different types of work uniforms). Physiological stress will be evaluated from rectal temperature and heart rate measurements.
- Conditions
- Physiological Stress
- Being tested
- clothing type, protective garments of Paul Boye Technologies
- Keywords
- stress when dressed, protective garment, work clothes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clothing type, protective garments of Paul Boye TechnologiesOther
The experiment aimed at evaluating the physiological stress obtained when dressed in different clothing (NBC protective garment [charcoal base], combat garment and 2 different types of work uniforms- (1)50% cotton and 50% polyester (2)80% cotton and 20% polyester) and during exertion under heat conditions.
| Study group | Role | What they receive |
|---|---|---|
| Research arm | Experimental | 1. 1 day which will include: physician examination,ECG,anthropometric measurements and Vo2max test.
2. 6 acclimatization days carried out by a standard protocol including a daily 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% HR) and when dressed in shorts.At the sixth day, the subjects will be dressed in a standard work uniform as a baseline exposure. Core (rectal) and skin temperature and heart rate will be monitored continuously.
3. 4 experiment days carried out by the following protocol: 2 hour walk on a treadmill (5 Km/h,2% incline) under heavy heat stress conditions (30 deg. centigrade,60% RH) and when dressed each time with different clothing out of 4 options:
1. NBC protective garment (charcoal base).
2. combat garment.
3. 2 different types of work uniforms. physiological stress will be examined based on rectal temperature and heart rate measurements. Receives: Other: clothing type, protective garments of Paul Boye Technologies |
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 a heat tolerance test (HTT).
Measured: 10 days for each participant
Secondary outcomes (4)
Rectal temperature
The rectal temperature will be monitored by a rectal thermistor during each heat tolerance test (HTT).
Measured: 10 days for each participant
Skin temperature
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
Measured: 10 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: 10 days for each participant
Sweat rate (composite)
Sweat rate will be calculated from the patients' body weight and fluid balance.
Measured: 10 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 posted13 May 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionDec 2015
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
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
- NCT02442947
- Sponsor's protocol ID
- SHEBA-14-1853-YH-CTIL
- Status last verified
- Dec 2015
- First submitted
- 29 Apr 2015
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Examination of Textile Solutions for Stress Reduction When Dressed in Protective Garment and Work Clothes and Under Physical and Heat Stress Conditions
- ClinicalTrials.gov ID
- NCT02442947
- Acronym / sponsor ID
- SHEBA-14-1853-YH-CTIL
- Conditions
- Physiological Stress
- Keywords
- stress when dressed, protective garment, work clothes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 May 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.
Using protective or combat garments under heavy heat stress conditions, during rest or exertion, may hinder the body's ability to effectively exchange heat with the environment and thereby can lead to heat injuries. The purpose of this research is to physiologically examine the new textile solutions that are planned to be integrated in the protective garments, combat garments and work uniforms in the army, by evaluating the physiological stress obtained during exertion under hot climatic conditions.
Detailed description
10 young, healthy civilian volunteers will participate in this study. After reading and signing an informed consent form, all subjects will undergo medical examination which includes ECG, anthropometric measurements and Vo2max test. Afterwards, the subjects will perform 6 acclimatization days carried out by the standard protocol of Heat Tolerance Test (HTT). After acclimatization, the subjects will undergo 4 experiment days under heavy heat stress in a climatic chamber, dressed in each experiment day with one out of 4 clothing combinations (NBC protective garment [charcoal base], combat garment and 2 different types of work uniforms). Physiological stress will be evaluated from rectal temperature and heart rate measurements.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research arm | Experimental | Other: clothing type, protective garments of Paul Boye Technologies1. 1 day which will include: physician examination,ECG,anthropometric measurements and Vo2max test. 2. 6 acclimatization days carried out by a standard protocol including a daily 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% HR) and when dressed in shorts.At the sixth day, the subjects will be dressed in a standard work uniform as a baseline exposure. Core (rectal) and skin temperature and heart rate will be monitored continuously. 3. 4 experiment days carried out by the following protocol: 2 hour walk on a treadmill (5 Km/h,2% incline) under heavy heat stress conditions (30 deg. centigrade,60% RH) and when dressed each time with different clothing out of 4 options: 1. NBC protective garment (charcoal base). 2. combat garment. 3. 2 different types of work uniforms. physiological stress will be examined based on rectal temperature and heart rate measurements. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-30 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 skeledon 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 |
|---|---|---|
| clothing type, protective garments of Paul Boye TechnologiesThe experiment aimed at evaluating the physiological stress obtained when dressed in different clothing (NBC protective garment [charcoal base], combat garment and 2 different types of work uniforms- (1)50% cotton and 50% polyester (2)80% cotton and 20% polyester) and during exertion under heat conditions. | Other | Research arm |
Primary outcome
physiological strain (composite)
Time frame: 10 days for each participant
The physiological strain will be determined by body core temperature and heart rate of the subjects during a heat tolerance test (HTT).
4 secondary outcomes
Rectal temperature
Time frame: 10 days for each participant
Skin temperature
Time frame: 10 days for each participant
Heart rate
Time frame: 10 days for each participant
Sweat rate (composite)
Time frame: 10 days for each participant
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 24 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 clothing type, protective garments of Paul Boye Technologies 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: finished, as of the sponsor's last update on 24 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?
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?
physiological strain (composite) (time frame: 10 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 24 Dec 2015.