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Effect of Swimming Training and Omega-3 Intake on Irisin and Body Composition in Obese Girls with Down Syndrome

Protocol summary

Study aim
The purpose of the present study was to omega-3 intake and eight weeks of swimming training on irisin and body composition obese girls with Down syndrome.
Design
Clinical trial with two groups with parallel, non-blind, randomized, randomized grouping were used.
Settings and conduct
Shahid Rezaei Brothers Pool, District 5 of Tehran, in addition to its daily activities, had 8 weeks of swimming training, which was 3 sessions per week and an average of 60 minutes per session. Swimming activities included a total of 10 minutes of warming up, 45 minutes of breast crawl swimming, and five minutes of cooling down.
Participants/Inclusion and exclusion criteria
Inclusion criteria;Girls with Down Syndrome 3 to 15 years old, general practitioner's approval, daily activities, especially swimming. Exclusion criteria; Epilepsy, limb defects and Multi-disability
Intervention groups
Intervention Group 1 includes people with Down syndrome (9 people) who receive aerobic exercise intervention. Group 2 intervention includes people with Down syndrome (9 people) who receive omega-3 supplementation with aerobic exercise.
Main outcome variables
Irisin, body mass index, fat percentage, muscle percentage, cholesterol, triglycerides, Low Density Lipoprotein,High Density Lipoprotein

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200506047324N1
Registration date: 2020-06-05, 1399/03/16
Registration timing: retrospective

Last update: 2020-06-05, 1399/03/16
Update count: 0
Registration date
2020-06-05, 1399/03/16
Registrant information
Name
ElhamAlsadat Zeinali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2288 8541
Email address
elhamz528@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Swimming Training and Omega-3 Intake on Irisin and Body Composition in Obese Girls with Down Syndrome
Public title
Effect of Swimming Training and Omega-3 Intake on Irisin and Body Composition in Obese Girls with Down Syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Girls with Down Syndrome, 3 to 15 years old, in the pool of Shahid Rezaei Brothers,Region 5 Tehran Public health approval based on a special questionnaire and general practitioner's approval In addition to daily activities, they have their own swimming exercises
Exclusion criteria:
People with epilepsy any physiological or metabolic abnormalities physical problems and obvious genetic abnormalities And there are several disabilities
Age
From 3 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 18
Randomization (investigator's opinion)
Randomized
Randomization description
Simplified Accidentalization Method Simple Accidental Methods Used Individual Accidental Hidden Sequence Sequence The use of opaque envelopes for division into two groups was a randomization tool using Rand Between software that divided individuals into two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad of Tehran University of Medical Sciences
Street address
Shariati St. - Khaghani St. - Islamic Azad University of Medical Sciences, Tehran - School of Medicine
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2019-09-01, 1398/06/10
Ethics committee reference number
IR.IAU.TMU.REC.1398.082

Health conditions studied

1

Description of health condition studied
Down Syndrome
ICD-10 code
Q90
ICD-10 code description
Down syndrome

Primary outcomes

1

Description
Irisin
Timepoint
Measure before using Omega 3 and training and after eight weeks of intervention
Method of measurement
ELISA method using ELISA Kit irisin kit with a picogram sensitivity of milliliters

2

Description
body weight
Timepoint
Measure before using Omega 3 and training and after eight weeks of intervention
Method of measurement
INBODY device

3

Description
fat percentage
Timepoint
Measure before using Omega 3 and training and after eight weeks of intervention
Method of measurement
INBODY device

4

Description
Muscle percentage
Timepoint
Measure before using Omega 3 and training and after eight weeks of intervention.
Method of measurement
INBODY device

5

Description
Cholesterol
Timepoint
Measure before using Omega 3 and training and after eight weeks of intervention
Method of measurement
Laboratory method

6

Description
Tri glyceride
Timepoint
Measure before using Omega 3 and training and after eight weeks of intervention
Method of measurement
Laboratory method

7

Description
Low Density Lipoprotein
Timepoint
Measure before using Omega 3 and training and after eight weeks of intervention
Method of measurement
Laboratory method

8

Description
High Density Lipoprotein
Timepoint
Measure before using Omega 3 and training and after eight weeks of intervention
Method of measurement
Laboratory method

9

Description
Height
Timepoint
Measure before using Omega 3 and training and after eight weeks of intervention
Method of measurement
centimeter

Secondary outcomes

empty

Intervention groups

1

Description
Swimming training, 8 weeks of swimming exercises, 3 sessions per week and an average of 60 minutes of swimming activity per session, which includes 10 minutes of warming up, 45 minutes of breast crawl swimming and five minutes of cooling. Warming up includes stretching exercises. It was out of the water and walking and warming up in the water. Cooling also includes playing in the water
Category
Other

2

Description
Intervention group: Swimming Training + Omega 3 Supplements 3. Get pre-workout supplements that have received 300 mg of Omega 3 capsules for 8 weeks and three times a week. Omega-3 capsules were purchased from the Ministry of Health's pharmaceutical company Alhawi.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
ElhamAlsadat Zeinali
Street address
Hafez Alley,at the end of Bani Hashem North Street, Resalat Highway
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2000
Email
info@royaninstitute.org

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Meysam Mohammadnia
Street address
Afsariyeh Three Ways - Imam Reza Highway - 18 km - Shahr Ghiamdasht - End of Shahid Bahonar St. - Islamic Azad University, East Tehran Branch
City
Tehran
Province
Tehran
Postal code
1866113118
Phone
+98 21 3359 4950
Email
info@iauet.ac.ir
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
ElhamAlsadat Zeinali
Position
Master of Sports Nutrition
Latest degree
Master
Other areas of specialty/work
Others
Street address
No 37,West Kavian Alley,Jolfa Street
City
Tehran
Province
Tehran
Postal code
1541749415
Phone
+98 21 2284 3502
Email
ases.zeinali@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahin Riyahi Malayeri
Position
Assistant Professor of Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Afsariyeh Three Ways - Imam Reza Highway - 18 km - Ghiamdasht City - End of Shahid Bahonar St. - Islamic Azad University, East Tehran Branch - Physical Education and Sports Sciences Department
City
Tehran
Province
Tehran
Postal code
1866113118
Phone
+98 21 3359 4950
Email
shahinriyahi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Personal
Full name of responsible person
ElhamAlsadat Zeinali
Position
Master of Sports Nutrition
Latest degree
Master
Other areas of specialty/work
Others
Street address
No 37,West Kavin Alley.Jolfa Street
City
Tehran
Province
Tehran
Postal code
1541749415
Phone
+98 21 2284 3502
Email
ases.zeinali@yahoo.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
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
All data can be shared after people have not been identified
When the data will become available and for how long
After completing the research
To whom data/document is available
Sending data only to academic and scientific institutions
Under which criteria data/document could be used
Scientific research journals for judging articles
From where data/document is obtainable
Through the author in charge of Shahin Riahi Malayeri shahinriyahi @ yahoo.com
What processes are involved for a request to access data/document
Sending a request to the desired email will be received one week after sending
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