Protocol summary

Summary
The aim of this semi experimental study was to evaluate the effect of aerobic exercise on Treatment girl students suffering from Attention Deficit-Hyperactivity Disorder (ADHD). 120 girl students suffering from such disorder participated in this study. 30 of the subjects with average age range of (10.41±1.43) who had the highest ADHD disorder were purposefully selected as samples and were randomly divided into two equally groups of experimental and control (n=15). The inclusion criteria were the age range of 7-12 as well as the psychiatrist's diagnosis of ADHD whereas the exclusion criterion were every physical, sensational, dynamic disorders as well as using medication related to them . To be assure of the existence of such disorder, an Child symptom inventory-4 (CSI-4) based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) was used. The experimental group received 12 weeks of one hour aerobic exercise 3 sessions per week.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013072610493N3
Registration date: 2013-08-15, 1392/05/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-15, 1392/05/24
Registrant information
Name
Mohammad Ebrahim Bahram
Name of organization / entity
Isfahan University
Country
Iran (Islamic Republic of)
Phone
+98 36 2334 3133
Email address
m.bahram@spr.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor For Research -Isfahan University.
Expected recruitment start date
2012-05-09, 1391/02/20
Expected recruitment end date
2012-08-10, 1391/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 12 Weeks Aerobic Exercises Interval Running on Treatment of Attention Deficit-Hyperactivity Disorder in Children.
Public title
The effect of aerobic exercise on Attention Deficitand and Hyperactivity Disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. The psychiatrist's diagnosis of hyperactivity disorder and attention deficit (ADHD). 2. The age range of 7-12 3. The existence of at least 6 symptoms of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Exclusion criteria: 1. Children with every physical, sensational, dynamic, and psychic disorder. 2. Suffering from a chronic disease. 3. Mental retardation, a history of seizures. 4. Use of related medication. 5. Parent's Disagreement.
Age
From 7 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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 Isfahan University, Department of Physical Education
Street address
Department of Physical Education of Isfahan University, Isfahan.
City
Isfahan
Postal code
8174673441
Approval date
2012-05-04, 1391/02/15
Ethics committee reference number
231

Health conditions studied

1

Description of health condition studied
Attention deficit and Hyperactivity disorders.
ICD-10 code
F90
ICD-10 code description
Hyperkinetic disorders

Primary outcomes

1

Description
Hyperactivity disorder.
Timepoint
Before and after 12 week aerobic exercise Interval running
Method of measurement
Child symptom inventory-4 (CSI-4)

Secondary outcomes

1

Description
Attention deficit
Timepoint
Before and after 12 week aerobic exercise Interval running
Method of measurement
Child symptom inventory-4 (CSI-4)

Intervention groups

1

Description
Experimental group: Aerobic exercise running for 30 to 45 minutes in 12 weeks, 3 sessions a week. Each session lasting one hour.
Category
Treatment - Other

2

Description
Control group: Did not receive any training.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University
Full name of responsible person
Mohammad Ebrahim Bahram
Street address
Department of Physical Education of Isfahan University, Isfahan.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor For Research -Isfahan University.
Full name of responsible person
Mohammad Ebrahim Bahram
Street address
Department of Physical Education of Isfahan University, Isfahan.
City
Isfahan
Grant name
ندارد
Grant code / Reference number
Not have
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor For Research -Isfahan University.
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
Isfahan University
Full name of responsible person
Mohammad Ebrahim Bahram
Position
Msc
Other areas of specialty/work
Street address
Department of Physical Education of Isfahan University, Isfahan.
City
Isfahan
Postal code
8174673441
Phone
+98 31 1793 2128
Fax
Email
bahramsport2010@gmail.com
Web page address
WWW.Ui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University
Full name of responsible person
Mohammad Ebrahim Bahram
Position
Msc
Other areas of specialty/work
Street address
Department of Physical Education of Isfahan University, Isfahan.
City
Isfahan
Postal code
7344181746
Phone
+98 31 1793 2128
Fax
Email
Bahramsport2010@gmail.comM.bahram@spr.ui.ac.ir
Web page address
WWW.Ui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University
Full name of responsible person
Mohammad ebrahim bahram
Position
Msc
Other areas of specialty/work
Street address
Department of Physical Education of Isfahan University, Isfahan.
City
Isfahan
Postal code
8174673441
Phone
+98 31 1793 2128
Fax
Email
bahramsport2010@gmail.com M.bahram@spr.ui.ac.ir
Web page address
www.Ui.ac.ir

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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