Physiological Strain of Weight Bearing.minkalNCT01565876
Auxiliary Device to Alleviate Soldiers' Backload
A study testing "Minkal"- Auxiliary device to alleviate backload in people with Physiological Strain of Weight Bearing., run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial summary
Combat soldiers are required to perform under strenuous physical conditions; hence, their physical fitness is a crucial factor in their survivability. The Auxiliary Device- "Minkal", is suggested (by its manufactures) to be able to reduce the soldiers' physiological strain by lowering the absolute load being carried… Read more about this study
- Who is it for?
- Ages 21 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physiological Strain of Weight Bearing.
- What is being tested?
- "Minkal"- Auxiliary device to alleviate backload
- 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
- Dec 2012to Jan 2014
- 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 21 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without any of the following: chronic background diseases, cardiovascular, lung or respiratory, heat stroke history, headaches,psychiatric background, musculoskeletal problems, and without drugs use.
- Lack of any acute disease during 2 weeks prior the study.
- Subjects will give their written consent for participating the study after being informed by the study's physician about the study's aims, importance and the possible risks.
Who cannot join
- Rectal temperature above 39 Celsius degrees.
- HR above maximal HR ( calculated as 220-age)
- The subject's will to stop the test.
- The researcher's/doctor's judgment.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Institute of military physiology
Ramat Gan
Yuval Heled, PhD, +972-3-7376584
Chen Makernatz, MD
About this study
Combat soldiers are required to perform under strenuous physical conditions; hence, their physical fitness is a crucial factor in their survivability.
The Auxiliary Device- "Minkal", is suggested (by its manufactures) to be able to reduce the soldiers' physiological strain by lowering the absolute load being carried by the soldier. As a result, it may improve the soldier's physiological abilities and performance through enduring missions with heavy loads, and may lead to better protection on the soldier from overuse injuries.
- Conditions
- Physiological Strain of Weight Bearing.
- Being tested
- "Minkal"- Auxiliary device to alleviate backload
- Keywords
- weight bearing, physiological load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Minkal"- Auxiliary device to alleviate backloadDevice
The participants will undergo 6 days of study. The first day of the study include medical examination, maximal oxigen consumption day and anthropometric mesurments.
Then The participants will undergo heat tolerance test 5 times (in different days).
first day- without load. second day- with back load of 40% of the body weight. third day- with back load of 40% of the body weight and the Auxilairy Device. fourth day- with back load of 60% of the body weight. fifth day- with back load of 60% of the body weight and the Auxilairy Device. The rectal temperature, skin teperature and heart rate will be mesured each day and compered afterwards.
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | The participants will undergo 6 days of study. The first day of the study include medical examination, maximal oxigen consumption day and anthropometric mesurments.
Then The participants will undergo heat tolerance test 5 times (in different days).
first day- without load. second day- with back load of 40% of the body weight. third day- with back load of 40% of the body weight and the Auxilairy Device. fourth day- with back load of 60% of the body weight. fifth day- with back load of 60% of the body weight and the Auxilairy Device. The rectal temperature, skin teperature and heart rate will be mesured each day and compered afterwards. Receives: Device: "Minkal"- Auxiliary device to alleviate backload |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological Load with and without the auxiliary device
The physiological load will be measured using a heat tolerance test(HTT). Each paricipant will undergo a HTT 5 times (in different days). first day- without load. second day- with back load of 40% of the body weight. third day- with back load of 40% of the body weight and the Auxilairy Device. fourth day- with back load of 60% of the body weight. fifth day- with back load of 60% of the body weight and the Auxilairy Device. The rectal temperature, skin teperature and heart rate will be mesured in each HTT and compered afterwards to assess the physiological load.
Measured: 6 days for each patient.
Secondary outcomes (4)
Rectal temperature
The Rectal temperature will be mesured by a rectal thermistore during each HTT.
Measured: 6 days
Skin temperature
The Skin temperature will be mesured by skin thermistores on three sites (chest, leg and arm).
Measured: 6 days
Heart Rate
Heart rate will be monitored using a polar watch.
Measured: 6 days
Sweat Rate
Sweat rate will be calculated from the patient's weight and his water balance.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological Strain of Weight Bearing.Studies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, amit druyan, Medical Corps, Israel Defense Force
- Investigators
- Chen Makernatz, MD, Principal investigator, Institute physicianYuval Heled, PhD, Study director, Director of the military physiology institute, IDF medical corpsRan Yanovich, MA, Study director, The director's deputy of the military physiology institute, IDF medical corps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565876
- Sponsor's protocol ID
- 963-2010-CLIL
- Acronym
- minkal
- Status last verified
- Mar 2012
- First submitted
- 4 Jul 2011
- Last updated
- 29 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auxiliary Device to Alleviate Soldiers' Backload
- ClinicalTrials.gov ID
- NCT01565876
- Acronym / sponsor ID
- minkal / 963-2010-CLIL
- Conditions
- Physiological Strain of Weight Bearing.
- Keywords
- weight bearing, physiological load
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 29 Mar 2012 (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.
Combat soldiers are required to perform under strenuous physical conditions; hence, their physical fitness is a crucial factor in their survivability.
The Auxiliary Device- "Minkal", is suggested (by its manufactures) to be able to reduce the soldiers' physiological strain by lowering the absolute load being carried by the soldier. As a result, it may improve the soldier's physiological abilities and performance through enduring missions with heavy loads, and may lead to better protection on the soldier from overuse injuries.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Device: "Minkal"- Auxiliary device to alleviate backloadThe participants will undergo 6 days of study. The first day of the study include medical examination, maximal oxigen consumption day and anthropometric mesurments. Then The participants will undergo heat tolerance test 5 times (in different days). first day- without load. second day- with back load of 40% of the body weight. third day- with back load of 40% of the body weight and the Auxilairy Device. fourth day- with back load of 60% of the body weight. fifth day- with back load of 60% of the body weight and the Auxilairy Device. The rectal temperature, skin teperature and heart rate will be mesured each day and compered afterwards. |
Who may qualify
- Ages
- 21 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects without any of the following: chronic background diseases, cardiovascular, lung or respiratory, heat stroke history, headaches,psychiatric background, musculoskeletal problems, and without drugs use.
- Lack of any acute disease during 2 weeks prior the study.
- Subjects will give their written consent for participating the study after being informed by the study's physician about the study's aims, importance and the possible risks.
Key exclusion criteria (4 listed)
- Rectal temperature above 39 Celsius degrees.
- HR above maximal HR ( calculated as 220-age)
- The subject's will to stop the test.
- The researcher's/doctor's judgment.
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 |
|---|---|---|
| "Minkal"- Auxiliary device to alleviate backloadThe participants will undergo 6 days of study. The first day of the study include medical examination, maximal oxigen consumption day and anthropometric mesurments. Then The participants will undergo heat tolerance test 5 times (in different days). first day- without load. second day- with back load of 40% of the body weight. third day- with back load of 40% of the body weight and the Auxilairy Device. fourth day- with back load of 60% of the body weight. fifth day- with back load of 60% of the body weight and the Auxilairy Device. The rectal temperature, skin teperature and heart rate will be mesured each day and compered afterwards. | Device | study |
Primary outcome
Physiological Load with and without the auxiliary device
Time frame: 6 days for each patient.
The physiological load will be measured using a heat tolerance test(HTT). Each paricipant will undergo a HTT 5 times (in different days). first day- without load. second day- with back load of 40% of the body weight. third day- with back load of 40% of the body weight and the Auxilairy Device. fourth day- with back load of 60% of the body weight. fifth day- with back load of 60% of the body weight and the Auxilairy Device. The rectal temperature, skin teperature and heart rate will be mesured in each HTT and compered afterwards to assess the physiological load.
4 secondary outcomes
Rectal temperature
Time frame: 6 days
Skin temperature
Time frame: 6 days
Heart Rate
Time frame: 6 days
Sweat Rate
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2012.
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.
Chen Makernatz, MD principal investigator
Institute physician
Yuval Heled, PhD study director
Director of the military physiology institute, IDF medical corps
Ran Yanovich, MA study director
The director's deputy of the military physiology institute, IDF medical corps
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Minkal"- Auxiliary device to alleviate backload in people with Physiological Strain of Weight Bearing., 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?
The sponsor lists 3 inclusion and 4 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 Mar 2012. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological Load with and without the auxiliary device (time frame: 6 days for each patient.). 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 Mar 2012.