Comparison of some immune response in serum and saliva at healthy men after one bout of exhaustive aerobic exercise
Design
This study is a non-randomized clinical trial and it will be a single group.
Settings and conduct
This clinical trial study will be conducted in physical education hall of Tabriz University of Medical Sciences. Intervention group will be measured during one exercise session on criteria such as cortisol in saliva and urine sample.
Participants/Inclusion and exclusion criteria
Inclusion criteria included: age between 19-21, having no infectious and inflammatory disease and being male, and exclusion criteria included being female and having the disease.
Intervention groups
The intervention group consists of individuals who will participate in an exhausting exercise session and then measure what will be needed.
Main outcome variables
Cortisol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200119046192N1
Registration date:2020-03-01, 1398/12/11
Registration timing:prospective
Last update:2020-03-01, 1398/12/11
Update count:0
Registration date
2020-03-01, 1398/12/11
Registrant information
Name
iran akhtari shojaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4901
Email address
akhtary20@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of some immune response in serum and saliva at healthy men after one bout of exhaustive aerobic exercise
Public title
Comparison of some immune response in serum and saliva
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
21>age>19
Male
No inflammatory disease
Exclusion criteria:
Female
Presence of infection disease
Age
From 19 years old to 21 years old
Gender
Male
Phase
2-3
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)
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 tabrize university of medical sciences
Street address
No.65., Azadi aveu., amirkabir street
City
tabriz
Province
East Azarbaijan
Postal code
5173814834
Approval date
2020-01-04, 1398/10/14
Ethics committee reference number
Ir.tbzmed.rec.1398.1094
Health conditions studied
1
Description of health condition studied
Cortisol
ICD-10 code
Y93.A3
ICD-10 code description
Activity, aerobic and step exercise
Primary outcomes
1
Description
Cortisol
Timepoint
قبل از انجام مداخله و بلافاصله بعد از انجام مداخله
Method of measurement
Eliza method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group will attend a post-exercise exercise session after the study; cortisol levels will be measured before and immediately after the intervention through saliva and serum samples. The hormone will be measured with the help of an ELISA device.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Tabriz
Full name of responsible person
Ebrahim Akhtari shojaei
Street address
No. 65, Azadi Street., AmirKabir
City
Tabriz
Province
East Azarbaijan
Postal code
5173814834
Phone
+98 41 3441 5683
Email
Akhtary20@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ebrahim Akhtarishojaei
Street address
No.65, Azadi Street., Amirkabir
City
Tabriz
Province
East Azarbaijan
Postal code
5173814834
Phone
+98 41 3441 5683
Email
Akhtary20@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ebrahim Akhtari Shojaei
Position
Reseacher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No.65., Azadi Street, Amirkabir
City
Tabriz
Province
East Azarbaijan
Postal code
5173814834
Phone
+98 41 3441 5683
Email
Akhtary20@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ebrahim Akhtari Shojaei
Position
Reseacher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No.65, Azadi street, Amirkabir
City
Tabriz
Province
East Azarbaijan
Postal code
5173814834
Phone
+98 41 3441 5683
Email
Akhtary20@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ebrahim Akhtari Shojaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No.65, Azadi Street, Amirkabir
City
Tabriz
Province
East Azarbaijan
Postal code
5173814834
Phone
+98 41 3441 5683
Email
Akhtary20@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available