The comparison between the effect of aerobic exercise and no excercise on salivary immunoglobulin a, cortisol, body composition and physical fitness in children with allergic rhinitis .
Aim:The study aim to compare the effect of aerobic exercise and no excercise on salivary immunoglobulin a, cortisol, body composition and physical fitness in children with allergic rhinitis.
Design: This is a controlled clinical trial. setting and conduct: 19 children with allergic rhinitis aged between 6-7 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 6-7 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 excercis program. Main outcome measures: The levels of immunogloboline A and cortisol physical fitness test (sit and reach, 30 meter sprint test, vertical jump and 4× 10 m shuttle run test) and body composition will be measured.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015061422498N1
Registration date:2015-08-12, 1394/05/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-12, 1394/05/21
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
2014-09-23, 1393/07/01
Expected recruitment end date
2015-06-26, 1394/04/05
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, cortisol, body composition and physical fitness in children with allergic rhinitis .
Public title
The comparison between the effect of aerobic exercise and no excercise on salivary immunoglobulin a, cortisol, body composition and physical fitness in children with allergic rhinitis.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:Children Aged 6-7 years old; and Allergic Rhinitis Exclusion Criteria: No Willing to Attend .
Age
From 6 years old to 7 years old
Gender
Male
Phase
2
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
Other
Other design features
Randomization by Closed Pockets
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Human Studies Review Committee at Islamic Azad University of Rasht
Street address
Lakan Boulvard
City
Rasht
Postal code
3516-41335
Approval date
2015-01-31, 1393/11/11
Ethics committee reference number
11721404822004
Health conditions studied
1
Description of health condition studied
Allergic Rhinitic
ICD-10 code
J30
ICD-10 code description
Vasomotor and allergic rhinitis
Primary outcomes
1
Description
cortisol level
Timepoint
after six weeks of excercise training
Method of measurement
microplate Enzyme linked Immunosorbent Assay
2
Description
Immunoglobulin A level
Timepoint
after six weeks of excercise training
Method of measurement
microplate Enzyme linked Immunosorbent Assay
Secondary outcomes
1
Description
Body Composition
Timepoint
6 weeks after Excercise Training
Method of measurement
BMI , WHR and Weight
2
Description
Fitness Indicators
Timepoint
After Six Weeks Of Exercise Training
Method of measurement
Fitness Test : Flexibility Test , 30 Meter Sprint, Sarjent Test And 4 In 10 Meters Agility
Intervention groups
1
Description
Intervention group 1: 6 Weeks Aerobic Excercise with 60 Minutes Lenght, 3 Sessions per Week including 10 Minutes Warm up, 10 Minutes Cool down and 40 minutes Aerobic Excercise with Moderate Intensity
Category
Lifestyle
2
Description
control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sarafraz Elementary School
Full name of responsible person
Shiva Nemati
Street address
Lakan BVL
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Rasht
Full name of responsible person
Ramin Shabani
Street address
Lakan BVL
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Rasht
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
Islamic Azad university of Rasht
Full name of responsible person
Ramin Shabani
Position
Associate Professor
Other areas of specialty/work
Street address
Lakan BVL
City
Rasht
Postal code
3516-41335
Phone
+98 13 3343 0503
Fax
Email
shabani@iaurasht.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Rasht
Full name of responsible person
Ramin Shabani
Position
Associate Professor
Other areas of specialty/work
Street address
Lakan BVL
City
Rasht
Postal code
3516-41335
Phone
+98 13 3343 0503
Fax
Email
shabani@iaurasht.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Rasht
Full name of responsible person
Shiva Nemati
Position
MSc
Other areas of specialty/work
Street address
Lakan BVL
City
Rasht
Postal code
3516-41335
Phone
+98 13 3343 0503
Fax
Email
shiva_nemati87@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)