- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ramat- Gan
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Tel-Hashomer, Ramat- Gan, Israel
- Sheba Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
CPK measured from blood sample (3ml) in the lab
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 3 experiment days
|
core temperature will be monitored using telemetry pill
|
3 experiment days
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SHEBA-15-2188-OF-CTIL
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