The effect of aquatic exercise, Vitamin D supplementation and interactive of aquatic exercise and Vitamin D supplementation on serum level of IL-1B, IL-6, IL-10, IL-1ra, TNF-a, hs-CRP and Vitamin D in Children with Autism Spectrum Disorders
The effect of aquatic exercise, Vitamin D supplementation and interactive of aquatic exercise and Vitamin D supplementation on serum level of IL-1B, IL-6, IL-10, IL-1ra, TNF-a, hs-CRP and Vitamin D in Children with Autism Spectrum Disorders
Design
Randomised, factorial design and double blinded trial, with three intervention and one control group, Selection of available samples and randomised replacement in groups
Settings and conduct
execution of Blood sampling at Razi lab
aquatic Exercise in the Behzisty pool of Rasht
Vitamin D supplements based on the prescription of pediatric neurosurgeons
Participants, Blood sampling, Laboratory scientist and Expert statistician, except the researcher and his aides, did not know the grouping of people in the research groups
Participants/Inclusion and exclusion criteria
sex (males)
age (6 to 14)
not having co-morbid disability
parents satisfaction and presence
Intervention groups
aquatic exercise
vitamin D supplementation
interaction of aquatic exercise and vitamin D supplementation
control
The effect of aquatic exercise, Vitamin D supplementation and interactive of aquatic exercise and Vitamin D supplementation on serum level of IL-1B, IL-6, IL-10, IL-1ra, TNF-a, hs-CRP and Vitamin D in Children with Autism Spectrum Disorders
Public title
The effect of interactive of aquatic exercise and Vitamin D supplementation on some inflammatory Cytokines, hs-CRP and Vitamin D levels in Children with Autism Spectrum Disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age (6 to 14)
sex (male)
not having co-morbid disability
Exclusion criteria:
Having more than two absence in the treatment sessions
Receiving specialized treatment in addition to the usual treatments at their institution
Age
From 6 years old to 14 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
40 children aged 6-14 years with autism spectrum disorder were selected using available sampling method. They will randomly divided into three intervention groups and one control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, participants are unaware of the group assigned to themselves and other participants. A separate workout hour is considered for each intervention group.
experts in laboratory analysis are also unaware of the type of intervention and the participating groups.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rasht Azad University Medical Sciences