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

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.

Study Overview

• Status: Unknown
• Conditions: Clothing
• Intervention / Treatment: Device: New Fighting Clothing

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ha'Merkaz
    • Ramat Gan, Ha'Merkaz, Israel, 5262000
      • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects; All subjects in this trial will receive the new fighting clothing while performing the study protocol	Device: New Fighting Clothing; VO2max test Clothing examination- 2-hour walk in 6 kph/4% elevation under 30 degrees Celsius and 60% relative humidity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body temperature	Using rectal thermometer	During intervention period (2 hours test) only
Heart rate	Using heart rate watch	During intervention period (2 hours test) only

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Medical Corps, Israel Defense Force

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SHEBA-19-6652-SS-CTIL; 2017-2019-IDF (Registry Identifier: Israel Defense Forces (IDF))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No