The effect of physical activity with and without cognitive demand on the improvement of executive function and behavioral symptoms in children with ADHD
Investiging the effect of moving activities demanding cognitive exercises and without cognitive exercises on the improvement of behavioral symptoms and executive functions in children with attention deficit disorder and hyperactivity.
Design
Clinical trial with active control group, will be conducted with double-blind randomized parallel groups on 30 patients and sealed envelope will be used for randomization.
Settings and conduct
-Experimental half in which random clinical trial project with active control group (Pre-test Post-test) will have been used. The place of experiment will be the psychological clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Being diagnosed with attention deficit hyperactivity disorder by a psychiatrist
Being 7 to 12 years old
Having informed consent to participate in research
Exclusion criteria:
Having comorbid disorders such as learning disabilities, conduct disorders, etc.
Having borderline IQ.
Intervention groups
In the intervention group, the motor activities performed require cognitive exercises that can be effective in improving the behavioral symptoms and executive functions of children with attention deficit hyperactivity disorder.
In the control group, only aerobic exercise activities without cognitive exercises are presented.
Main outcome variables
pCognitive rehabilitation based on movement, executive functions, behavioral symptoms, attention deficit disorder and hyperactivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200706048032N1
Registration date:2020-10-22, 1399/08/01
Registration timing:prospective
Last update:2020-10-22, 1399/08/01
Update count:0
Registration date
2020-10-22, 1399/08/01
Registrant information
Name
Vahid Nejati
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 7609
Email address
nejati@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-31, 1399/08/10
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of physical activity with and without cognitive demand on the improvement of executive function and behavioral symptoms in children with ADHD
Public title
Physical activity in children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of attention deficit hyperactivity disorder by a psychiatrist
Placement between the ages of 7 and 12.
Having informed consent to participate in research
Exclusion criteria:
Having other comorbid disorders such as learning disability, conduct disorder, etc.
Having borderline IQ.
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The limited block randomization method will be used for randomization, so that in order to determine the experimental and control groups, 15 balls with code A will be considered for the experimental group and 15 balls with code B for the control group. They will then be placed inside the lottery container and, without replacement, the balls will be randomly removed from the container and the sequence created will be recorded. Next, based on the research sample size, a number of aluminum envelopes are prepared and each random sequence is recorded on a card. The cards are placed in the envelopes in order. To maintain the random sequence, the envelopes are numbered in the same way on their outer surface. Finally, the flaps of envelopes will be glued and then they are placed in a box in order. At the beginning of the participants’ registration, according to the entry order of participants qualified for including in the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants after obtaining informed consent and being randomly placed in the experimental and control groups, will not receive any information about how the other group is intervened, as well as how they themselves are positioned as the experimental group or the control group; and also the evaluators of individual results will be selected from outside the study team. In this case, the researcher's own knowledge of the type of intervention assigned to the study participants can not affect the data analysis.
Placebo
Used
Assignment
Parallel
Other design features
In the intervention, motor activities are performed with cognitive exercises.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Medical Sciences
Street address
Islamic Azad University of Medical Sciences, Tehran Branch,KHaghani St,Shariyati St,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.IAU.TMU.REC.1398.046
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
Behavioral symptoms
Timepoint
At the beginning of the study (before the intervention) and 45, 75 days after the intervention
Method of measurement
Conners Behavioral Symptoms Scale for Parents and Teachers
2
Description
Working memory
Timepoint
At the beginning of the study (before the intervention) and 45, 75 days after the intervention
Method of measurement
Neurological test (N-back)
3
Description
Inhibit response
Timepoint
At the beginning of the study (before the intervention) and 45, 75 days after the intervention
Method of measurement
Neurological test (go-no go)
4
Description
Cognitive flexibility
Timepoint
At the beginning of the study (before the intervention) and 45, 75 days after the intervention
Method of measurement
Neurological test (Wisconsin)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:: In this group, the intervention is presented in the form of purposeful motor activities that require cognitive tasks. The tools required for the intervention is the cognitive rehabilitation software based on Excir (Nejati) movement, which tries to rehabilitate and strengthen cognitive functions by purposefully increasing the cognitive needs of the movement. For this purpose, considering the principles governing cognitive rehabilitation and movement, motor tasks have been designed that progressively involve various cognitive functions. In this program, in addition to cognitive rehabilitation software, several color banners are used on which different numbers and directions and different colors are designed, and the participants move on the banners according to the cognitive tasks provided in the software. Participants will do these tasks twice a week for one hour.
Category
Rehabilitation
2
Description
Control group:: In this group, aerobic activities such as running, which do not require cognitive tasks, are presented. Participants will perform these movements twice a week for one hour in a safe environment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychology Clinic of Shahid Beheshti University
Full name of responsible person
Vahid Nejati
Street address
Unit5,Floor1, Velenjak St, Daneshjoo Blvd ,Shahid Beheshti Universiti, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2240 7601
Fax
+98 21 2240 7601
Email
nejati@sbu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Dr. Babak Shokri
Street address
Unit50,Floor4,Velenjak St, Daneshjoo Blvd, University Shahid Beheshti , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2429
Fax
Email
heydari-M@SBU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?