Aim: The study aim to compare the effects of aerobic exercise and no exercise on salivary immunoglobulin A and cortisol in children with allergic rhinitis. Design: This is a controlled clinical trial. Setting and conduct: 19 children with allergic rhinitis aged between 6 to 7 years will tend voluntarily in this study and will be randomly divided into experimental and control groups.
Major inclusion and exclusion criteria: The inclusion criteria are 6 to 7 years of age, and allergic rhinitis. The exclusion criteria is no willing to attend in this study. Intervention: Subjects in the experimental group will participate in aerobic exercise program for 6 weeks. The control group will not attend in any exercise program. Main outcome measures: The levels of immunoglobulin A and cortisol will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062622498N2
Registration date:2015-08-03, 1394/05/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-03, 1394/05/12
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between the effect of aerobic exercise and no excercise on salivary immunoglobulin A and cortisol in children with allergic rhinitis.
Public title
The comparison between the effect of aerobic exercise and no excercise on salivary immunoglobulin A and cortisol in children with allergic rhinitis.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: children aged 6 to 7 years old; and allergic rhinitis
Exclusion criteria: no willing to participate.
Age
From 6 years old to 7 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
19
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The randomization by closed pockets
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University Rasht Branch
Street address
Taleshan Bridge, Azad University
City
Rasht
Postal code
3516141335
Approval date
2014-08-23, 1393/06/01
Ethics committee reference number
11721404822004
Health conditions studied
1
Description of health condition studied
Allergic Rhinitis
ICD-10 code
J30
ICD-10 code description
Vasomotor and allergic rhinitis
Primary outcomes
1
Description
Immunoglobulin A level
Timepoint
Before aerobic exercise and after the end of the period
Method of measurement
Immunoglobulin A specific kits
2
Description
Cortisol
Timepoint
Before aerobic exercise and after the end of the period
Method of measurement
Cortisol specific kits
Secondary outcomes
empty
Intervention groups
1
Description
control group: no Intervention will be performed.
Category
N/A
2
Description
Intervention group 1: 6 weeks aerobic exercise with 60 minutes Lenght, 3 Sessions per week including 10 Minutes Warm up, 10 Minutes Cool down and 40 minutes aerobic exercise with moderate intensity.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarafraz School
Full name of responsible person
Shiva Nemati
Street address
Loghman Alley, Moallem Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
-
Full name of responsible person
-
Street address
-
City
-
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
-
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
Azad University Rasht Branch
Full name of responsible person
Ramin Shabani
Position
Assistant Professor
Other areas of specialty/work
Street address
Taleshan Bridge
City
Rasht
Postal code
3516141335
Phone
+98 13 3343 0503
Fax
Email
shabani@iaurasht.ac.ir;
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Azad university Branch Rasht
Full name of responsible person
Ramin Shabani
Position
Assistant Professor
Other areas of specialty/work
Street address
Taleshan Bridge
City
Rasht
Postal code
3516141335
Phone
+98 13 3343 0503
Fax
Email
shabani@iaurasht.ac.ir;
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Azad University Rasht Branch
Full name of responsible person
Shiva Nemati
Position
Master of Science
Other areas of specialty/work
Street address
Taieshan Bridge
City
Rasht
Postal code
3516141335
Phone
+98 13 3343 0503
Fax
Email
shiva_nemati87@yahoo.com;
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)