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The Effect of selected exercise training on physical fitness indices and social interaction in childeren with autism spectrum disorders.

Protocol summary

Study aim
The aim of this study was to investigate the effect of a selected exercise program on physical fitness and social interaction indices in children with autism.
Design
A clinical trial with a control group (n = 8) and an intervention group (n = 8), single-blind, randomized, was used to randomize the rand function of Excel software.
Settings and conduct
The training program of the present study included combined aerobic resistance exercises that were performed three sessions per week for eight weeks in the environment of Sabzevar Autism School. The test taker and data analyst did not know the groups.
Participants/Inclusion and exclusion criteria
Admission requirements: Children with autism, age 5 to 10 years, clinical examination by a physician to perform physical activity, no history of cardiorespiratory disease, written consent of parents or legal guardian of the child, no severe mobility restrictions Exclusion criteria: inability to perform exercise, not attending regular exercise sessions (3 consecutive sessions and 5 non-consecutive sessions, injury, illness and any other obvious disorders other than autism that can be considered as the main diagnosis, personal reasons
Intervention groups
The experimental group participated in a selective exercise program consisting of hand-held play, rhythmic movements by rhythmic song and resistance training with stretching for 8 weeks (3 sessions per week). The control group engaged in normal daily activities
Main outcome variables
: cardio-respiratory endurance, lower body explosive power, upper body muscle power, back muscle flexibility, balance, claw strength, coordination, agility, social interactions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220103053616N1
Registration date: 2022-01-09, 1400/10/19
Registration timing: retrospective

Last update: 2022-01-09, 1400/10/19
Update count: 0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Shokofeh Broughani
Name of organization / entity
Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 51 4467 5281
Email address
shokofeh.broughani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-06-03, 1398/03/13
Actual recruitment start date
2019-04-04, 1398/01/15
Actual recruitment end date
2019-06-03, 1398/03/13
Trial completion date
2019-06-03, 1398/03/13
Scientific title
The Effect of selected exercise training on physical fitness indices and social interaction in childeren with autism spectrum disorders.
Public title
The Effect of selected exercise training on physical fitness indices and social interaction in childeren with autism spectrum disorders.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with autism Age 5 to 10 years Clinical examination by a specialist doctor for physical activity No history of cardiorespiratory disease Written consent of the child's parent or legal guardian No severe movement limitations
Exclusion criteria:
Inability to perform the exercise Absence from regular training sessions (3 consecutive sessions and 5 non-consecutive sessions) Injury Illness and any other obvious disorder other than autism that can be considered as the main diagnosis. personal reasons
Age
From 5 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 21
Actual sample size reached: 16
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software was used for randomization tools and to hide allocation concealment from opaque envelopes sealed with random sequence. In this method, each of the random sequences created was recorded on a card and the cards were placed in the envelopes of the letter, respectively. In order to maintain a random sequence, the envelopes were numbered in the same way on the outer surface. Finally, the letter envelopes were glued and placed in a box, respectively. Eligible participants, one of the envelopes was opened in order, and the group assigned to that participant was revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessors and data analysts did not know which individual belonged to the control group or the experimental group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research OF Hakim Sabzevari University
Street address
Hakim Sabzevari University,Tohid Shahr,Sabzevar,Khorasan Razavi
City
SABZEVAR
Province
Razavi Khorasan
Postal code
9617976487
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.HSU.REC.1398.004

Health conditions studied

1

Description of health condition studied
AUTISM spectrum disorders
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
social interaction
Timepoint
At the beginning of the study (before the intervention) and eight weeks after the start of the exercise program
Method of measurement
Gilliam Autism Test (GARZ)

2

Description
physical fitness Indices ( Anthropometric tests, cardiopulmonary endurance, leg and trunk explosive power, hand muscle strength, flexibility, static balance, agility, hand grip strength, coordination)
Timepoint
At the beginning of the study (before the intervention) and eight weeks after the start of the exercise program
Method of measurement
For anthropometric evaluation, height and weight were measured by meters and scales. Body mass index was calculated by dividing weight (kg) by height squared (m2). Evaluation of cardiorespiratory fitness (20-meter shuttle run test), explosive power (sergeant test), trunk explosive power (medical ball throwing test), static balance (strok test), agility (T test), hand grip strength (hand dynamometer), flexibility (Wells test) and coordination of the Nelson selective response motor test were used.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The experimental group participated in a selective exercise program consisting of hand-held play, rhythmic movements by rhythmic song and resistance training with stretching for 8 weeks (3 sessions per week).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sabzevar Autism School
Full name of responsible person
Education
Street address
No. 15, Eram 19, Eram st, sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9618665737
Phone
+98 51 4467 5281
Email
shokofeh.broughani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Mohammad Ibrahim Hajiabadi
Street address
No. 15, Eram19, Eram ST, Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9618665737
Phone
+98 51 4467 5281
Email
shokofeh.broughani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hakim Sabzevari University
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
shokofeh broughani
Position
Student
Latest degree
Master
Other areas of specialty/work
Physical Education
Street address
No. 15, Eram19, Eram ST, Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9618665737
Phone
+98 51 4467 5281
Email
shokofeh.broughani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
shokofeh broughani
Position
student
Latest degree
Master
Other areas of specialty/work
Physical Education
Street address
No. 15, Eram19,Eram ST, sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9618665737
Phone
+98 51 4467 5281
Email
shokofeh.broughani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Shokofeh Broughani
Position
Student
Latest degree
Master
Other areas of specialty/work
Physical Education
Street address
No. 15 ,Eram19 ,ERAM St, sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618665737
Phone
+98 51 4467 5281
Fax
Email
shokofeh.broughani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome, and its results are shared
When the data will become available and for how long
Access started from 2021
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
To carry out research projects
From where data/document is obtainable
sending email
What processes are involved for a request to access data/document
Send email and the purpose and reason for the request
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