Studying the effect of aquatic exercise on endocrine indices, renal and hepatic enzymes, and hematological indices in children with autism spectrum disorder taking risperidone
Studying the effect of aquatic exercise on endocrine indices, renal and hepatic enzymes, and hematological indices in children with autism spectrum disorder taking risperidone
Design
clinical trial, with one intervention group and one control group, double-blind, convenience sampling, and random group replacement.
Settings and conduct
This is a clinical trial study, including pre-test and post-test with two intervention and control groups, in which the effect of the independent variable of aquatic exercise training on endocrine indices, renal and hepatic enzymes, and hematological indices in 8-14 year old children with autism spectrum disorder taking risperidone will be investigated. The intervention will be conducted in the Welfare Organization swimming pool, and blood tests will be performed in a specialized laboratory. The researchers involved in the pre-test and post-test assessments and the statistician will be blinded to the allocation of individuals to the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Gender Boy (8-14 years old)
Having autism grade 1 and 2
Taking risperidone for at least one year
exclusion criteria: Having diseases that limit sports activity
Intervention groups
Aquatic exercise group: Children with autism spectrum disorder who receive aquatic exercise intervention for 10 weeks.
Control group: Children with autism spectrum disorder who do not receive aquatic exercise during the 10-week research protocol.
Main outcome variables
Insulin resistance indices
Metabolic syndrome indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180503039517N14
Registration date:2025-04-10, 1404/01/21
Registration timing:retrospective
Last update:2025-04-10, 1404/01/21
Update count:0
Registration date
2025-04-10, 1404/01/21
Registrant information
Name
Soleyman Ansari Kolachahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2906
Email address
solomonansari@phd.iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-05, 1403/12/15
Expected recruitment end date
2025-03-15, 1403/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of aquatic exercise on endocrine indices, renal and hepatic enzymes, and hematological indices in children with autism spectrum disorder taking risperidone
Public title
The effect of aquatic exercise on endocrine and hematological indices of children with autism spectrum disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gender: Boy (8-14 years old)
Having autism grade 1 and 2 (the diagnosis of autism severity will be made by a specialist psychologist according to the Gars-2 scale)
Taking risperidone for at least one year to reduce behavioral or sleep problems in children
Exclusion criteria:
having cardiovascular, musculoskeletal, and metabolic diseases limiting physical activity
Age
From 8 years old to 14 years old
Gender
Male
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Forty Children with autism spectrum disorder will be selected by available sampling method.
Through the draw (the names of the participants were written on paper and through random draw) they will be divided into experimental and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the persons responsible for evaluating and collecting information, as well as the data analyst, are unaware of the type of intervention and the participants in the research groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Islamic Azad University - Sari Branch
Street address
Farah Abad Road
City
Sari
Province
Mazandaran
Postal code
48164-14
Approval date
2025-02-16, 1403/11/28
Ethics committee reference number
IR.IAU.SARI.REC.1403.381
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Insulin resistance indicators
Timepoint
48 hours before the intervention and 48 hours after 10 weeks of intervention
Method of measurement
Blood samples were taken in two stages, 48 hours before and after 8 weeks of intervention, after a 12-hour overnight fast, in the amount of 10 cc of blood, in a sitting position, from the brachial vein.
2
Description
Metabolic syndrome indicators
Timepoint
48 hours before the intervention and 48 hours after 10 weeks of intervention
Method of measurement
Metabolic syndrome indicators including systolic and diastolic blood pressure, triglycerides, HDL, and waist-to-hip circumference are measured.
Secondary outcomes
1
Description
Liver enzymes
Timepoint
48 hours before the intervention and 48 hours after 10 weeks of intervention
Method of measurement
Serum AST and ALT levels will be measured before and after the intervention with a photometric method by the Dialab Laboratory kit (Austrian -made).
2
Description
Kidney function indicators
Timepoint
48 hours before the intervention and 48 hours after 10 weeks of intervention
Method of measurement
Serum levels of urea, creatinine, and BAN indicators are measured before and after the intervention using Biotechnical Autoanalyzer (made in Italy).
3
Description
Hematological indicators
Timepoint
48 hours before the intervention and 48 hours after 10 weeks of intervention
Method of measurement
White and red blood cells, hematocrit, and platelets will be measured using the Cell Counter (made of Japan).
4
Description
Thyroid hormones
Timepoint
48 hours before the intervention and 48 hours after 10 weeks of intervention
Method of measurement
Thyroid hormones including T3 and T4 will be measured using Immunoassay AIA 360 (Made in America)
5
Description
Adipokines
Timepoint
48 hours before the intervention and 48 hours after 10 weeks of intervention
Method of measurement
Adipokines including adiponectin, Leptin, Resistin, and Asprosin will be measured through Elisa using the Shanghai Sunteam Biotech (made of China).
6
Description
Lipid profile
Timepoint
48 hours before the intervention and 48 hours after 10 weeks of intervention
Method of measurement
Normal values of serum triglyceride, total cholesterol, LDL, and HDL levels will be measured through Photometry Method Using Pars azmoon kit (Made in Iran)
Intervention groups
1
Description
Intervention group: Children in the aquatic exercise group will be examined by a physician to obtain permission to participate in the training sessions and will participate in water exercise sessions two days a week for 10 weeks (20 sessions in total). During the study, the pool will be completely available to the participants. Each exercise session will last 60 minutes and will include a 5-minute warm-up (forming a circle, walking clockwise and counterclockwise), 20 minutes of aerobic exercise (practicing leg crawling across the pool with the help of a swimming board, running in place, jumping), 20 minutes of strength training (moving away, approaching, bending and extending the arms and legs) using water resistance, 10 minutes of free swimming (retrieving an object from the pool floor, passing through a hula hoop and playing with other children), and 5 minutes of cool-down (similar to a warm-up). This program will be implemented under the supervision of a researcher, two physical education graduate students, and with the presence of two occupational therapy students to maintain a 1:2 instructor-to-child ratio, and with the presence of one parent to provide assistance in the educational process.
Category
Treatment - Other
2
Description
Control group: Participants in this group will not receive any intervention and will continue their daily routine as usual.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Baran Autism Association
Full name of responsible person
Dr Nooshin Shahbahrami
Street address
Bisotun Street, Safari Alley, Foladluy 2nd Alley, Gilan Autism Association Institute
City
Rasht
Province
Guilan
Postal code
4193191933
Phone
+98 13 3342 4073
Email
solomonansari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soleyman Ansari
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
4193191933
Phone
+98 911 230 6198
Email
solomonansari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fahimeh AdibSaber
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
4193191933
Phone
+98 910 103 3889
Email
adibsaberf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fahimeh AdibSaber
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
4193191933
Phone
+98 910 103 3889
Email
adibsaberf@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fahimeh AdibSaber
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Lakan Blv
City
Rasht
Province
Guilan
Postal code
4193191933
Phone
+98 910 103 3889
Email
adibsaberf@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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