Motor ActivityNCT02476344
Classification and Characterization of Physical Strains During Sorting Series: Physiological Aspects
A study testing experiment protocol in people with Motor Activity, run by Sheba Medical Center at 1 site in Israel.
Trial summary
2 young candidates have tragically died during army pre-recruitment sorting series in 2006. As part of the classification and characterization of the physical aspects of the training, this experiment was requested. Read more about this study
- Who is it for?
- Ages 18 to 22 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- experiment protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Oct 2016
- 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 22 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-22 years.
- Healthy civilian volunteers.
- without skeleton-muscle illnesses.
- without Infectious disease 2 weeks prior to the experiment.
Who cannot join
- any physical condition.
- physician decition.
Trial locations and contacts
1 site in 1 country.
About this study
2 young candidates have tragically died during army pre-recruitment sorting series in 2006. As part of the classification and characterization of the physical aspects of the training, this experiment was requested.
We aim at determining the characteristics of physical strains in sorting series, by objective and subjective parameters and evaluating the difficulty levels and intensity of those strains.
Read the detailed description
each subject will perform the following 3 days experiment protocol, consisting of army training exercises:
- sack carrying exercise; the subjects will go up and down through a steep slope with sand sack on their back (path length is 200 meters,10 repetitions). the first day will also include recruitment and medical examination, in addition to the exercise.
- crawling exercise; the subjects will crawl with knee's protectors back and forth (path length is 20 meters,15 repetitions).
- combined exercise: sprints session (path length 600 meter, 3 repetitions),15 min break, sack carrying session (same protocol as first day), 45 min break and crawling session (same protocol as the second day). during all exercises heart rate, core temperature, lactic acid and CPK levels will be monitored continuously.
- Conditions
- Motor Activity
- Being tested
- experiment protocol
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experiment protocolOther
each subject will perform the following 3 days experiment protocol, consisting of army training exercises:
- sack carrying exercise.
- crawling exercise.
- combined exercise: sack carrying, crawling and sprints. heart rate, core temperature, lactic acid and CPK levels will be monitored continuously.
| Study group | Role | What they receive |
|---|---|---|
| research arm | Experimental | 40 subjects will undergo the experiment protocol, total 3 days, each consisting different training exercises. Receives: Other: experiment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch)
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Measured: 3 experiment days
Secondary outcomes (3)
CPK measured from blood sample (3ml) in the lab
CPK levels will be measured from blood sample (3ml) in the lab
Measured: 3 experiment days
lactic acid measured using lactat-meter (Lactate pro LT-1710)
lactic acid levels from finger blood (5ul) using lactat-meter (Lactate pro LT-1710)
Measured: 3 experiment days
body core temperature monitored using telemetry pill
core temperature will be monitored using telemetry pill
Measured: 3 experiment days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT02476344
- Sponsor's protocol ID
- SHEBA-15-2188-OF-CTIL
- Status last verified
- Jul 2015
- First submitted
- 17 Jun 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification and Characterization of Physical Strains During Sorting Series: Physiological Aspects
- ClinicalTrials.gov ID
- NCT02476344
- Acronym / sponsor ID
- SHEBA-15-2188-OF-CTIL
- Conditions
- Motor Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 19 Jun 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.
2 young candidates have tragically died during army pre-recruitment sorting series in 2006. As part of the classification and characterization of the physical aspects of the training, this experiment was requested.
We aim at determining the characteristics of physical strains in sorting series, by objective and subjective parameters and evaluating the difficulty levels and intensity of those strains.
Detailed description
each subject will perform the following 3 days experiment protocol, consisting of army training exercises:
- sack carrying exercise; the subjects will go up and down through a steep slope with sand sack on their back (path length is 200 meters,10 repetitions). the first day will also include recruitment and medical examination, in addition to the exercise.
- crawling exercise; the subjects will crawl with knee's protectors back and forth (path length is 20 meters,15 repetitions).
- combined exercise: sprints session (path length 600 meter, 3 repetitions),15 min break, sack carrying session (same protocol as first day), 45 min break and crawling session (same protocol as the second day). during all exercises heart rate, core temperature, lactic acid and CPK levels will be monitored continuously.
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: experiment protocol40 subjects will undergo the experiment protocol, total 3 days, each consisting different training exercises. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-22 years.
- Healthy civilian volunteers.
- without skeleton-muscle illnesses.
- without Infectious disease 2 weeks prior to the experiment.
Key exclusion criteria (2 listed)
- any physical condition.
- physician decition.
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 |
|---|---|---|
| experiment protocoleach subject will perform the following 3 days experiment protocol, consisting of army training exercises: 1. sack carrying exercise. 2. crawling exercise. 3. combined exercise: sack carrying, crawling and sprints. heart rate, core temperature, lactic acid and CPK levels will be monitored continuously. | Other | research arm |
Primary outcome
heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch)
Time frame: 3 experiment days
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
3 secondary outcomes
CPK measured from blood sample (3ml) in the lab
Time frame: 3 experiment days
lactic acid measured using lactat-meter (Lactate pro LT-1710)
Time frame: 3 experiment days
body core temperature monitored using telemetry pill
Time frame: 3 experiment days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 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 experiment protocol in people with Motor Activity, 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 4 inclusion and 2 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 14 Jul 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?
heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch) (time frame: 3 experiment days). 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 14 Jul 2015.