NCT04317027

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 16, 2020

Last Update Submit

March 18, 2020

Conditions

Clothing

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

All subjects

EXPERIMENTAL

All subjects in this trial will receive the new fighting clothing while performing the study protocol

Device: New Fighting Clothing

Interventions

New Fighting ClothingDEVICE

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

All subjects

Eligibility Criteria

Age20 Years - 28 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Ha'Merkaz, 5262000, Israel

Location

Central Study Contacts

Sagi Shpizer, MD

CONTACT

+972523439957SagiArie.Shpizer@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Heller Institute of Medical Research

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 20, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)