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IRCT20201211049678N1 IRCT 2021-07-29 Islamic Azad University Exercise and nutrition effect on Autism 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 2021-07-11 anticipated 80 Complete https://irct.ir/trial/57068 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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 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. N/A Autism Spectrum Disorder. Intervention 1: 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. Intervention 2: Online nutritional education group will participate in online nutritional education sessions for 3 time per week and 30 minutes in each session. Intervention 3: 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. Intervention 4: Control group will not receive any exercise or online nutritional education intervention and only will participate in pre-test and post-test. Yes - There is a plan to make this available What will be shared: Data from variables and their outcomes will be available after Unidentifiabling When: 6 month after results publication To whom: Researchers Conditions: Researchers can use study design and its results for future studies Where to obtain: Researcher How to obtain: Researchers can contact for future information for future studies after results publication via kimia.moiniafshari@srbiau.ac.ir Comments:
public Mandana Gholami
Science and Research Branch, Daneshgah Blvd, Simon Bulivar Blvd, Tehran
Tehran Iran (Islamic Republic of) ۱۴۷۷۸۹۳۸۵۵ +98 21 4486 5179 gholami_man@yahoo.com Islamic Azad University scientific Mandana Gholami
Science and Research Branch, Daneshgah Blvd, Simon Bulivar Blvd, Tehran
Tehran Iran (Islamic Republic of) 1477893855 +98 21 4486 5179 gholami_man@yahoo.com Islamic Azad University Iran (Islamic Republic of) 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 8 years 12 years Male Reaching to puberty according to specialist approval Any prohibition from physical activity Any medical conditions or disease which inhibits physical activity Other Other Other Other 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. Online nutritional education group will participate in online nutritional education sessions for 3 time per week and 30 minutes in each session. 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. Control group will not receive any exercise or online nutritional education intervention and only will participate in pre-test and post-test 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. 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. 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. 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. 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. 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. 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. 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. Fat mass. Timepoint: Before the study as pre-test and at the end of 8 weeks intervention as post-test. Method of measurement: Caliper. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Fat mass. Timepoint: Before the study as pre-test and at the end of 8 weeks intervention as post-test. Method of measurement: Caliper. 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. 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. 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. 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. 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. 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. 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. 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. Islamic Azad University Science And Research Branch Approved 2021-06-16 Islamic Azad university- science and research branch 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 Tehran Tehran Iran (Islamic Republic of)