Effect of Functional Exercise Along with online Nutritional Education on Inflammatory-Oxidative and Metabolic Profile in Children with Autism Spectrum Disorder during Covid-19 Pandemic
Effect of Functional Exercise Along with online Nutritional Education on Inflammatory-Oxidative and Metabolic Profile in Children with Autism Spectrum Disorder during Covid-19 Pandemic
Design
Randomized clinical trial with parallel groups on 80 children with autism spectrum disorder
Settings and conduct
This study will be recruited in selected autism and rehabilitation centers in Tehran. Participants will be randomly allocated in one of 4 study groups.this study will last for 8 weeks.
Functional training group will recruit training including warm-up, sits-to-stand with weight and stairs up and down training ends with stretch and cool down.
Online nutritional education groups will participate in online educational sessions for 8 weeks, 3 sessions per week for 15-30 minutes in each session
training+education groups will receive both interventions. Control groups will only participate in pre-test and post-test.
Participants/Inclusion and exclusion criteria
Participants of this study will be included 8-12 years old children (boys) with autism spectrum disorder diagnosed and approved by neurologist from selected centers in Tehran city. Participants will not enter the study in case of: reaching to puberty according to specialist approval, any inhibition from physical activity and any medical condition or disease which inhibit participant from physical activity.
Intervention groups
1) functional exercise group, 2) online nutritional education group, 3) functional exercise and online nutritional education group and 4) control group
Main outcome variables
Lipid profile
Insulin resistance indiator
waist to hip ratio (WHR)
body mass index (BMI)
fat mass
Physical fitness indicators
White blood cells (neutrophil, basophils, eusinophil)
C-reactive protein
Super oxide dismutase (SOD)
Glutathione peroxidase (GPx)
Catalase (CAT)
Lactate dehydrogenase (LDH)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201211049678N1
Registration date:2021-07-29, 1400/05/07
Registration timing:retrospective
Last update:2021-07-29, 1400/05/07
Update count:0
Registration date
2021-07-29, 1400/05/07
Registrant information
Name
Kimia Moiniafshari
Name of organization / entity
Science and research branch islamic azad university
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 4170
Email address
kimia.moinafshar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-11, 1400/04/20
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Functional Exercise Along with online Nutritional Education on Inflammatory-Oxidative and Metabolic Profile in Children with Autism Spectrum Disorder during Covid-19 Pandemic
Public title
Exercise and nutrition effect on Autism
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Autism spectrum disorder diagnosis approved by neurologist
No inhibition for physical activity
No experience of physical activity within past 6 month
Not reaching maturity according to specialist diagnosis
Exclusion criteria:
Reaching to puberty according to specialist approval
Any prohibition from physical activity
Any medical conditions or disease which inhibits physical activity
Age
From 8 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a clinical trial with pre-test and post-test and participants will be children diagnosed with autism spectrum disorder approved by neurologist. Targeted sampling with available participants will be recruited for participants selection. Among 100 eligible individuals, 80 participants will be selected according to Morgan chart. Then, participants will randomly receive specific codes by using random allocation software, without researches awareness. Participants will be divided into 4 groups according to their random codes as following: 1) functional exercise, 2) online nutritional education, 3) functional exercise+ online nutritional education and 4) control group. Participants with codes 1-20 will be allocated in functional exercise group, participants who received codes 21-40 will be allocated in online nutritional education group and allocation for functional exercise+ online nutritional education and control group will be for codes 41-60 and 61-80 respectively. In order to prevent from any bias, all sampling process, participants selection, specific codes allocation and participants grouping will be without researcher awareness. Moreover, the intervention process will be done under occupational therapist, physiotherapist and nutritionist super vision and via their assistance
Blinding (investigator's opinion)
Double blinded
Blinding description
Each candidate will randomly receive specific codes using random allocation software without researcher involvement or awareness. Participants will be allocated in one of the for groups according to their codes. All the sampling, randomized code allocation and grouping, will be recruited without researcher awareness and with occupational therapist, physiotherapist and nutritionist supervision and assistance.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad university- science and research branch
Street address
13th floor, Block A, ministry of health and medical education head quarter, Simaye Iran street, between South Falamak and Zarafshan street, Shahrake-e-Gharb, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۹۴۳۴۷۱
Approval date
2021-06-16, 1400/03/26
Ethics committee reference number
IR.IAU.SRB.REC.1400.003
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Lower limb strength
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Sits to stand test
2
Description
Upper limb strength
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
1 kilogram dumbbell press
3
Description
Abdominal strength
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Push ups test
4
Description
Flexibility
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Modified sit and reach test
5
Description
Cardio-respiratory endurance
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
6 minutes walking test
6
Description
Lipid profile
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
7
Description
Insulin resistance indicator
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
8
Description
Waist to hip circumference ratio (WHR)
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Waist and hip circumference measurement and division to each other
9
Description
Fat mass
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Caliper
10
Description
C-reactive protein (CRP)
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
11
Description
White blood cells (WBC)
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
12
Description
Superoxide dismutase enzyme (SOD)
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
13
Description
Lactate dehydrogenase enzyme
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital veil blood sample
14
Description
Glutathione peroxidase enzyme
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
15
Description
Catalase enzyme
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
16
Description
Speed
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
10 minutes walking test
17
Description
Balance
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Flamingo and Time-Up-and-GO tests
Secondary outcomes
1
Description
Lower limb muscle strenght
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Sit-to-stand test
2
Description
Upper limb muscle strenght
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
1 kilogram dumbbell press
3
Description
Abdominal muscle strenght
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Push-ups test
4
Description
Flexibility
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Modified sit-and-reach test
5
Description
Cardio-respiratory endurance
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
6 minutes walking test
6
Description
Lipid profile indicators
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
7
Description
Insulin resistance indicator
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
8
Description
Waist-to-hip ratio
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Waist and hip circumference measurement and division to each other
9
Description
Fat mass
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Caliper
10
Description
C-reactive protein
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
11
Description
White blood cells
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
12
Description
Superoxide dismutase enzyme
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
13
Description
Lactate dehydrogenase enzyme
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
14
Description
Gluthatione peroxidase enzyme
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital vein blood sample
15
Description
Catalase enzyme
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Anterior cubital blood vein sample
16
Description
Speed
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
10 minutes walking test
17
Description
Balance
Timepoint
Before the study as pre-test and at the end of 8 weeks intervention as post-test
Method of measurement
Flamingo and Time-Up-and-Go (TUGT) test
Intervention groups
1
Description
Functional group, will participate in 8 weeks functional training including warm up, going up and down the stairs, sit-to-stand using weight and cool down at the end of the sessions for 3 times per week for 60 minutes each session.
Category
Other
2
Description
Online nutritional education group will participate in online nutritional education sessions for 3 time per week and 30 minutes in each session.
Category
Other
3
Description
Functional exercise and online nutritional education group will participate in exercise and online education session for 8 weeks, 3 session per week for 90 minutes.
Category
Other
4
Description
Control group will not receive any exercise or online nutritional education intervention and only will participate in pre-test and post-test
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabesh Rehabiliation Center
Full name of responsible person
Mohammad Mohebi Rad
Street address
Yousefabad Street
City
Tehran
Province
Tehran
Postal code
1431943186
Phone
+98 21 8835 1829
Email
maryam9350@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kimia Moiniafshari
Street address
No 48, 25th Street, Azadegan Blvd, South Sheykh Bahai Street
City
Tehran
Province
Tehran
Postal code
1437694874
Phone
+98 21 8863 4170
Email
kimia.moinafshar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University Science And Research Branch
Proportion provided by this source
100
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
Islamic Azad University
Full name of responsible person
Mandana Gholami
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Science and Research Branch, Daneshgah Blvd, Simon Bulivar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
gholami_man@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mandana Gholami
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Science and Research Branch, Daneshgah Blvd, Simon Bulivar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
gholami_man@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mandana Gholami
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Science and Research Branch, Daneshgah Blvd, Simon Bulivar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
gholami_man@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data from variables and their outcomes will be available after Unidentifiabling
When the data will become available and for how long
6 month after results publication
To whom data/document is available
Researchers
Under which criteria data/document could be used
Researchers can use study design and its results for future studies
From where data/document is obtainable
Researcher
What processes are involved for a request to access data/document
Researchers can contact for future information for future studies after results publication via kimia.moiniafshari@srbiau.ac.ir