Classification and Characterization of Physical Strains During Sorting Series: Physiological Aspects

Motor Activity Clinical Trial

Official title:

Classification and Characterization of Physical Strains During Sorting Series: Physiological Aspects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02476344
• Other study ID #: SHEBA-15-2188-OF-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2015
• Last updated: July 12, 2015
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: July 2015
• Source: Sheba Medical Center
• Contact: Ofir Frenkel, M.D
• Phone: +972529243399
• Email: Ofir.Frenkel[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical 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.

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.

Description:

each subject will perform the following 3 days experiment protocol, consisting of army training exercises:

1. 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.

2. crawling exercise; the subjects will crawl with knee`s protectors back and forth (path length is 20 meters,15 repetitions).

3. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 22 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Motor Activity

Intervention

Other:
• experiment protocol
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.

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer	Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 experiment days	Yes
Secondary	CPK measured from blood sample (3ml) in the lab	CPK levels will be measured from blood sample (3ml) in the lab	3 experiment days	No
Secondary	lactic acid measured using lactat-meter (Lactate pro LT-1710)	lactic acid levels from finger blood (5ul) using lactat-meter (Lactate pro LT-1710)	3 experiment days	No
Secondary	body core temperature monitored using telemetry pill	core temperature will be monitored using telemetry pill	3 experiment days	No