Protocol summary

Summary
Thirty non-asthmatic professional soccer player, selected and crossed over in a project are divided into two sections when accidentally.Then both groups will be taught how to breathe properly spray. It is worth noting that we have two kind of sprays containing salbutamol other is a neutral, harmless substance that has the same taste, smell spray salbutamol(placebo). Fifteen minutes before testing for athletes in both groups were randomized to double blind testing is done using the spray. With respect to a drug cleared from the body(wash out period)Based on the half-life of inhaled salbutamol). subjects were again evaluated after inhalation of spray can be replaced with the difference that this time the drug and placebo groups is changed. (Naturally, neither the tester nor the subject of a spray containing are informed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205098117N3
Registration date: 2012-06-19, 1391/03/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-06-19, 1391/03/30
Registrant information
Name
Farzin Halabchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2282
Email address
fhalabchi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-05-04, 1391/02/15
Expected recruitment end date
2013-09-22, 1392/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of inhaled salbutamol on specific fitness standards in professional soccers, a double-blind clinical trial
Public title
Effects of inhaled salbutamol on specific fitness standards in professional soccers, a double-blind clinical trial
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: having a contract with a professional team and regular exercise. Exclusion criteria: history of asthma and EIA; having a history of restrictive lung disease volume; having a history of heart disease; respiratory viral infections in a month; history of atopy and skeletal abnormalities of the chest.
Age
From 17 years old to 33 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran - Ghods St., Keshavarz Blvd - Central Organization
City
Tehran
Postal code
Approval date
2012-05-02, 1391/02/13
Ethics committee reference number
90-03-53-15006-46538

Health conditions studied

1

Description of health condition studied
Fitness for soccer players
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Dedicated fitness
Timepoint
Before the intervention, 20 minutes after intervention
Method of measurement
Used FIFA standard test

Secondary outcomes

empty

Intervention groups

1

Description
In the first group: salbutamol spray, two puffs of 100 micrograms and control groups: placebo homogenous spray, two puffs of 100 micrograms should be administered
Category
Treatment - Drugs

2

Description
After wash out period :The second phase of the first drug to people who were given placebo and those on placebo was administered in the first stage of the drug is given
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Damash sport club
Full name of responsible person
Mr.sadeghi
Street address
Harandi sport complex
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Reserch deputy, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotohi
Street address
Keshavarz Blvd, Ghods St., Tehran University of Medical Sciences, Central Building, 5th Floor
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reserch deputy, Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehdi Abarashi
Position
MD, Sport medicine resident
Other areas of specialty/work
Street address
Imam khomeini hospital
City
Tehran
Postal code
Phone
Fax
Email
abarashi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Farzin Halabchi
Position
Assistant professor
Other areas of specialty/work
Street address
Imam khomeini hospital
City
Tehran
Postal code
Phone
Fax
Email
Fhalabchi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran medical science univercity
Full name of responsible person
Dr.abarashi-mahdi
Position
sports medicine resident
Other areas of specialty/work
Street address
Imam khomeini hospital
City
Tehran
Postal code
Phone
00
Fax
Email
abarashi@razi.tums.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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