Protocol summary

Summary
Objective: Comparison of effect of selected exercise program and earobic training on motor proficiency, executive function and serum brain-derived neurotrophic factor of children with Attention Deficit Hyperactivity Disorder (ADHD). Study Design: Subjects were divided randomly into three groups (control, selected exercise program and earobic training) and was designed as a double blind study. Inclusion criteria: Boys 7 to 12 years old with Attention Deficit / Hyperactivity of District 6 of the city of Mashhad. Exclusion criteria: IQ score below 70, children with Autism and other mental disorders and physical problems. Sample size: 60 children with ADHD. (B) Intervention study:Interventions were included of comparing the two types of exercise program (selected exercise program and earobic training program): 1- The selected exercise program is a set of physical exercises to improve motor skills (such as mobility, balance, coordination, speed and agility) and executive functions (inhibition, attention and concentration, planning and organizing, memory) in the form of the game individual and group with moderate to severe intensity were designed. 2-The aerobic training: Aerobic training program is contains a set of aerobic and physical exercises that are aimed at improving motor skills (such as mobility, balance, coordination, speed and agility) and executive functions (reaction time, inhibition control, attention, planning and organization , memory) with moderate to severe intensity were designed. (G) Intervention time: Interventions time were January and February 2016. The interventions were performed three days a week, 24 sessions in 8 weeks, with a time of 90 minutes. (D) The outcome of the study: A structured physical activity program may be used as a method to improve cognitive function and treat children with ADHD.

General information

Acronym
ADHD
IRCT registration information
IRCT registration number: IRCT2016031627075N1
Registration date: 2016-04-11, 1395/01/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-11, 1395/01/23
Registrant information
Name
Mozhgan Memarmoghaddam
Name of organization / entity
Ferdowsi University Of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 31 4625 2285
Email address
mmemarmoghaddam@stu.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad Ferdowsi University
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of selected exercise program and earobic training on motor proficiency, executive function and serum brain-derived neurotrophic factor of children with Attention Deficit Hyperactivity Disorder (ADHD)
Public title
The effect of exercise training program on children with Attention Deficit / Hyperactivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: boys 7 to 12 years old with Attention Deficit / Hyperactivity of District 6 of the city of Mashhad. Exclusion criteria: IQ score below 70, children with Autism and other mental disorders and physical problems.
Age
From 7 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad Ferdowsi University
Street address
Paradise Daneshgah,Azadi Square,Mashhad
City
Mashhad
Postal code
9177948979
Approval date
2014-08-12, 1393/05/21
Ethics committee reference number
3/30101

Health conditions studied

1

Description of health condition studied
Attention deficit / hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention

Primary outcomes

1

Description
Serum Brain-Derived Neurotrophic Factor
Timepoint
Before and two months after intervention
Method of measurement
ELISA

2

Description
Executive Functions
Timepoint
Before and two months after intervention
Method of measurement
Continuous Performance, Stroop, Go no go, the Tower of London,Digit Span from the Wechsler and Corsi block tapping tests

3

Description
Motor Proficiency
Timepoint
Before and two months after intervention
Method of measurement
Oseretsky Brvnynkz test

Secondary outcomes

1

Description
Sustained Attention
Timepoint
Before and two months after intervention
Method of measurement
Continuous Performance test

2

Description
Response Inhibition
Timepoint
Before and two months after intervention
Method of measurement
Stroop test

3

Description
Behavior Inhibition
Timepoint
Before and two months after intervention
Method of measurement
Go no go test

4

Description
Planning and Organizing
Timepoint
Before and two months after intervention
Method of measurement
Tower of London test

5

Description
Verbal Memory
Timepoint
Before and two months after intervention
Method of measurement
Digit Span from the Wechsler test

6

Description
Visual-spatial Memory
Timepoint
Before and two months after intervention
Method of measurement
Corsi Block Tapping test

Intervention groups

1

Description
The first intervention group: the selected exercise program that including perceptual - motor trainings and aerobic trainings. The intervention was conducted during 2 months, 24 sessions, three times per week and each session 90 minutes.
Category
Other

2

Description
The second intervention group: intervention aerobic training that includes training of running, aerobic games and running on a treadmill. Intervention during 2 months, 24 sessions, three times per week and each session was conducted 90 minutes.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Area 6 of Education of Mashhad
Full name of responsible person
Mozhgan Memarmoghaddam
Street address
Faculty of Physical Education & Sport science,Paradise Daneshgah,Azadi Square,Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
Hamidreza Taheri
Street address
Paradise Daneshgah,Azadi Square,Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad Ferdowsi 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
Mashhad Ferdowsi University
Full name of responsible person
Mozhgan Memarmoghaddam
Position
PhD student/ Masters
Other areas of specialty/work
Street address
Faculty of Physical Education & Sport science, Paradise Daneshgah,Azadi Square,Mashhad
City
Mashhad
Postal code
9177948979
Phone
+98 31 4625 2285
Fax
Email
mmemarmoghaddam@stu.um.ac.irmmemarmoghaddam@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
Mozhgan Memarmoghaddam
Position
PhD student/ Masters
Other areas of specialty/work
Street address
Faculty of Physical Education & Sport science,Paradise Daneshgah,Azadi Square,Mashhad
City
Mashhad
Postal code
9177948979
Phone
+98 31462252285
Fax
Email
mmemarmoghaddam@stu.um.ac.irmmemarmoghaddam@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
Mozhgn Memarmoghaddam
Position
PhD student/ Masters
Other areas of specialty/work
Street address
Faculty of Physical Education & Sport science,Paradise Daneshgah,Azadi Square,Mashhad
City
Mashhad
Postal code
9177948979
Phone
+98 31 4625 2285
Fax
Email
mmemarmoghaddam@stu.umz.ac.irmmemarmoghaddam@yahoo.com
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
Loading...