Protocol summary

Summary
1- Objectives: The study of the effect of two pre-cooling methods (cold water immersion and cold shower) on thermoregulation, dehydration status, plasma lactate, and electrolytes levels during a treadmill running test in the warm condition( temperature= 32- 34 °C , humidity= 50%). 2- Design: The design of the study was: a randomized controlled clinical trial. 3- Setting and conduct: Three study groups were involved in the study. The Control group conducted 45 minutes of treadmill running test after warm up. Cold Water Immersion group conducted the same treadmill running test after cold water immersion. Cold Shower group conducted the same test after cold shower exposure. 4- Participants: 24 young male soccer players (aged 15-18 years) were randomly divided into control, cold water immersion and cold shower groups (Inclusion criteria were: Young male soccer players; age between 15-18 years; regular engagement in competitive soccer training in the past 3 years. Exclusion criteria was: Subjects with any musculoskeletal injuries or inflammatory diseases. ). 5- Intervention: 10 minutes of cold water immersing, or 2 minutes of cold shower exposure. 6- Main outcome: plasma volume, oral temperature.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121325503N1
Registration date: 2016-01-23, 1394/11/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-23, 1394/11/03
Registrant information
Name
Ahmad Azad
Name of organization / entity
University of Zanjan
Country
Iran (Islamic Republic of)
Phone
+98 24 3305 4121
Email address
azad@znu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-05-01, 1393/02/11
Expected recruitment end date
2014-08-01, 1393/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of short term pre-cooling by cold water immersion and cold shower on dehydration, body temperature, plasma lactate, and electrolytes in young male soccer players during 45 minutes of treadmill running in warm environment.
Public title
The Effect of Body Pre-Cooling on Heat Stress
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria were: Young male soccer players; age between 15-18 years; regular engagement in competitive soccer training in the past 3 years. Exclusion criteria was: Subjects with any musculoskeletal injuries or inflammatory diseases.
Age
From 15 years old to 18 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of University of Zanjan
Street address
University of Zanjan, Research and Technology Vice-Presidency, University Blvd., Zanjan, I. R. Iran
City
Zanjan
Postal code
45371-38791
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
35579/پ

Health conditions studied

1

Description of health condition studied
Heat stress
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plasma volume
Timepoint
pre, mid and post test
Method of measurement
Dill and Costill method

2

Description
Body themperature
Timepoint
pre, mid and post test
Method of measurement
Thermometer

Secondary outcomes

1

Description
Plasma lactate
Timepoint
pre, mid and post test
Method of measurement
Kobas Auto-analyzer and kits manufactured by Randox Company of England

2

Description
Plasma Na and K
Timepoint
pre, mid and post test
Method of measurement
Electrolyte Analyzer

Intervention groups

1

Description
Control group:conducted 45 minutes of treadmill running test after a 10 minutes of warm (10 minutes treadmill run[7km/h])(tem=32-34 °C, humidity=50%) .
Category
Other

2

Description
Intervention(cold water immersion group): conducted 45 minutes of tread mill running test after 10 min of warm up+10 min of cold water immersion. Cold water immersion: A small pool filled with water of 24°C and the water temperature was maintained between22- 24 °C throughout immersion test. Participants immersed up to the neck for 10 minutes. (tem=32-34 °C, humidity=50%)
Category
Other

3

Description
intervention(cold shower group): conducted 45 minutes tread mill running test after 10 min of warm up+2 min of cold shower. The subjects stood under showers for 2 minutes. Water temperature was gradually reduced from 30- 32°C to18- 20°C (4°C / 30 seconds). (tem=32-34 °C, humidity=50%)
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mouood Soccer Club
Full name of responsible person
Vahid Davoody
Street address
Mouood Soccer Club, No. 3240 Iman Street, Phase 3, Ggolshahr, Zanjan, Iran
City
Zanjan

2

Recruitment center
Name of recruitment center
Setaregan Soccer Club
Full name of responsible person
Amir Mehry
Street address
Setaregan Soccer Club, No. 4007 Toulue Sharghi Street, Phase 3, Gholshahr, Zanjan, Iran
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Zanjan, Vice chancellorr for research
Full name of responsible person
Abolfazl Jalilvand
Street address
Research and technology Vic-presidency, University of Zanjan, University Blvd., Zanjan, I. R. Iran
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Zanjan, Vice chancellorr for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Zanjan
Full name of responsible person
Ahmad Azad
Position
PhD
Other areas of specialty/work
Street address
Department of Physical Education, Social Sciences Building, University of Zanjan, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 3344 2484
Fax
Email
azad@znu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Zanjan
Full name of responsible person
Ahmad Azad
Position
PhD
Other areas of specialty/work
Street address
Department of Physical Education, Social Sciences Building, University of Zanjan, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 3344 2484
Fax
Email
azad@znu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Zanjan
Full name of responsible person
Ahmad Azad
Position
PhD
Other areas of specialty/work
Street address
Department of Physical Education, Social Sciences Building, University of Zanjan, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 3344 2484
Fax
Email
azad@znu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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