Physiological Examination of New Fighting Clothing During Exposure to Exercise Under Hot Conditions

Clothing Clinical Trial

Official title:

Physiological Examination of New Fighting Clothing During Exposure to Exercise Under Hot Conditions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04317027
• Other study ID #: SHEBA-19-6652-SS-CTIL
• Secondary ID: 2017-2019-IDF
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: June 2021

Study information

• Verified date: March 2020
• Source: Sheba Medical Center
• Contact: Sagi Shpizer, MD
• Phone: +972523439957
• Email: SagiArie.Shpizer[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The use of fighting clothing under extreme heat conditions during rest and exercise, compromises the body's ability to maintain temperature within the narrow physiological range needed for regular function, and might lead to heat injury. Beside working and fighting clothing, the fighters also wear vests used for protection and equipment carrying, which leads to substantial reduction in effective dissipation area from the central region of the body. This fact is most substantial during exercise which increases metabolic heat production rate and leads to heat accumulation and rise in body temperature. Therefore the development of new textile technologies to allow rapid cooling during intervals is of great importance.

This study is designed to physiologically examine new textile solutions, by evaluating the physiological stress induced during exercise under mild heat conditions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 28 Years

Eligibility

Inclusion Criteria:

• Men

• Formerly fighters

• Healthy

• Without prior diseases including heart, vessel, respiratory and metabolic diseases or known use of medications

• experience in using fighting clothing

• VO2max > 50 ml/kg/min

Exclusion Criteria:

• Incapacity to fulfill inclusion criteria

Related Conditions & MeSH terms

• Clothing

Intervention

Device:
• New Fighting Clothing
VO2max test Clothing examination- 2-hour walk in 6 kph/4% elevation under 30 degrees Celsius and 60% relative humidity

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan	Ha'Merkaz

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body temperature	Using rectal thermometer	During intervention period (2 hours test) only
Primary	Heart rate	Using heart rate watch	During intervention period (2 hours test) only