The effectiveness of a group aerobic exercise program on body composition, physical and cognitive performance in children with pervasive developmental disorders: a randomized clinical trial
Objective: we aim to assign the children with Autism Spectrum Disorder (ASD) to a group exercise intervention in a controlled trial, regard to effect on physical and cognitive factors. 30 autistic children (aged 7-14 years old) are recruited through the special schools of Tehran, Iran; subjects are selected from a database which prepared from autism schools by research center of sport medicine, 2009-10. They are divided in two equal groups of intervention and control. All subjects are included if they have definite clinical and instrumental (ADI-R) diagnosis of ASD by the specialists. Any orthopedic disorder which may interrupt with the exercise ability of the children will result in exclusion. Intervention is applied for 15 subjects as a group exercise on a weekly schedule (2 times a week) up to 20 sessions and each session is 45 minutes. Another group will be with no intervention. Outcome measures include physical activity level and cognitive factors in children.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904204264N3
Registration date:2010-11-01, 1389/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-01, 1389/08/10
Registrant information
Name
Amirhossein Memari
Name of organization / entity
Sport Medicine Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 0227
Email address
sportpsych@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy, Tehran University of Medical Sciences
Expected recruitment start date
2010-07-03, 1389/04/12
Expected recruitment end date
2010-07-10, 1389/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of a group aerobic exercise program on body composition, physical and cognitive performance in children with pervasive developmental disorders: a randomized clinical trial
Public title
Physical education effects in autistic children
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 7-14 years old and high function participants with DSMIV based diagnosis of ASD which confirmed by ADI-R; Capable to walk independently; Allowed to exercise due to physician opinion. Exclusion criteria: orthopedics and musculoskeletal impairment that contradict to exercise, epilepsy.
Age
From 7 years old to 14 years old
Gender
Both
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
Tehran University of Medical Sciences Ethic Committee
Street address
Central University Building, Ghods st, Keshavarz Blv
City
Tehran
Postal code
14395-578
Approval date
empty
Ethics committee reference number
89-01-53-8641
Health conditions studied
1
Description of health condition studied
pervasive developmental disorder
ICD-10 code
F84.0
ICD-10 code description
childhood autism
Primary outcomes
1
Description
Physical factors
Timepoint
Before and after the intervention period
Method of measurement
BOTMP test
2
Description
physical activity
Timepoint
before and after intervention
Method of measurement
accelerometery
Secondary outcomes
1
Description
Cognitive and social factors
Timepoint
Pre and Pos intervention period
Method of measurement
WCST, ATEC tests
Intervention groups
1
Description
An adapted aerobic group exercise for intervention group; 20 sessions under coach instruction of 1 : 1 and weekly basis education (twice a week) is presented. Each session includes 45 minutes of adapted physical education which prompted by certified physical educators in an adapted rich context.
Category
N/A
2
Description
Control group: subjects are in waiting list with no adapted physical intervention
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center of Sport Medicine , Tehran University of Medical Sciences
Full name of responsible person
Memari, Amir Hossein
Street address
Jalale Ale Ahmad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotoohi
Street address
Central University Building, Ghods st, Keshavarz Blv
City
Tehran
Grant name
Grant code / Reference number
89-01-53-8641
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, Tehran University of Medical Sciences
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
Sport Medicine Research center
Full name of responsible person
Memari Amir Hossein
Position
Research Associate / MD
Other areas of specialty/work
Street address
N0 7, Jalale ale Ahmad
City
TEHRAN
Postal code
14395- 578
Phone
+98 21 8863 0227
Fax
+98 21 8800 3539
Email
sportpsych@tums.ac.ir
Web page address
WWW.sportpsychology.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sport Medicine Research Center
Full name of responsible person
Memari Amir Hossein
Position
Research Associate / MD
Other areas of specialty/work
Street address
No 7, Jalale Ale Ahmad
City
Tehran
Postal code
14395- 578
Phone
+98 21 8863 0227
Fax
+98 21 8800 3539
Email
sportpsych@tums.ac.ir
Web page address
www.sportpsychology.ir
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Memari Amir Hossein
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)