- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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Ramat- Gan
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Tel-Hashomer, Ramat- Gan, Israel
- Sheba Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
CPK measured from blood sample (3ml) in the lab
Tidsram: 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)
Tidsram: 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
Tidsram: 3 experiment days
|
core temperature will be monitored using telemetry pill
|
3 experiment days
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- SHEBA-15-2188-OF-CTIL
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