- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02476344
Classification and Characterization of Physical Strains During Sorting Series: Physiological Aspects
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.
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ramat- Gan
-
Tel-Hashomer, Ramat- Gan, Israel
- Sheba Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18-22 years.
- Healthy civilian volunteers.
- without skeleton-muscle illnesses.
- without Infectious disease 2 weeks prior to the experiment.
Exclusion Criteria:
- any physical condition.
- physician decition.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: research arm
40 subjects will undergo the experiment protocol, total 3 days, each consisting different training exercises.
|
each subject will perform the following 3 days experiment protocol, consisting of army training exercises:
heart rate, core temperature, lactic acid and CPK levels will be monitored continuously. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 experiment days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CPK measured from blood sample (3ml) in the lab
Time Frame: 3 experiment days
|
CPK levels will be measured from blood sample (3ml) in the lab
|
3 experiment days
|
|
lactic acid measured using lactat-meter (Lactate pro LT-1710)
Time Frame: 3 experiment days
|
lactic acid levels from finger blood (5ul) using lactat-meter (Lactate pro LT-1710)
|
3 experiment days
|
|
body core temperature monitored using telemetry pill
Time Frame: 3 experiment days
|
core temperature will be monitored using telemetry pill
|
3 experiment days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SHEBA-15-2188-OF-CTIL
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