Comparison of the Effect of Eight-Week Trx Exercise and Omega-3 Supplementation on Visfatin Level and Insulin Resistance in Women with Polycystic Ovary Syndrome.
The purpose of this study was to investigate the effect of eight weeks of trx training and omega-3 supplementation on serum visfatin levels and insulin resistance in women with PCOS.
Design
Twenty eight patients were randomly assigned to four complement, exercise, combination and control groups through lottery.
Settings and conduct
The participants were randomly divided into four groups by lottery and the complementary group was followed up through the complementary telegram channel and the intervention group of the training group and the combined gymnasium were conducted.
Participants/Inclusion and exclusion criteria
Women with polycystic ovarian syndrome aged 20-40 years, non-pregnancy, menopause, addiction, taking medications for blood pressure and hormone, diabetes, cardiovascular problems, renal failure, liver and thyroid problems, using omega-3 supplementation regularly in three Last month, as well as regular physical activity in the last three months.
Intervention groups
Exercise TRX and supplementation with omega-3
Main outcome variables
The implications of this study are to reduce insulin resistance and insulin levels and increase visfatin levels.
General information
Reason for update
Acronym
TRX
IRCT registration information
IRCT registration number:IRCT20180824040856N1
Registration date:2018-09-08, 1397/06/17
Registration timing:retrospective
Last update:2018-09-08, 1397/06/17
Update count:0
Registration date
2018-09-08, 1397/06/17
Registrant information
Name
Fariba Khoshkam
Name of organization / entity
Islamic Azad University Isfahan(Khorasgan)
Country
Iran (Islamic Republic of)
Phone
+98 31 3568 4210
Email address
zeraati3679@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-02, 1396/01/13
Expected recruitment end date
2017-06-15, 1396/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Eight-Week Trx Exercise and Omega-3 Supplementation on Visfatin Level and Insulin Resistance in Women with Polycystic Ovary Syndrome.
Public title
Effect of trx training and omega-3 supplementation in controlling polycystic ovary syndrome.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female
with polycystic ovarian syndrome
age 20-40 years
Exclusion criteria:
Pregnance
alcoholism or drugs
taking certain medications
menopause
cardiovascular problems
Liver problems
Renal failure
diabetes
taking omega-3 supplement regularly in the last three months
regular exercise in the last three months
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized randomization, in which I wrote the names of the participants on separate papers and placed in a container, I asked one person to read them one by one and I was replaced by training in four groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
TRX exercises have been used in this research, which is completely new and has not been applied to these participants until now.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Khorasgan Branch (Isfahan) Ethical Committee
Street address
t, Arghavia, University Blvd. East Gay St
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2018-06-03, 1397/03/13
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.018
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
insulin resistance
Timepoint
24 hours before intervention and two months after intervention
Method of measurement
Blood sampling
2
Description
Visfatin level
Timepoint
24 hours before intervention and two months after intervention
Method of measurement
Blood sampling
3
Description
Weight changes
Timepoint
24 hours before intervention and two months after intervention
Method of measurement
Scala Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Omega-3 supplementation. Receipt of 1000 mg capsule, daily dose of a capsule, after lunch, Zahravi Co.
Category
Lifestyle
2
Description
Intervention group2: Omega-3 supplementation and TRX exercise Get a 1000 mg capsule, a daily dose of capsule, after lunch, Zahrawi's company, and 24 sessions of TRX training, each session is an hour
Category
Lifestyle
3
Description
Intervention group3: Practice, 24 training sessions for TRX, duration of each session for one hour
Category
Lifestyle
4
Description
Intervention group 4: Control group
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Ferdos Mehrabian
Street address
Shahid Beheshti Hospital , Motahhari Ave
City
Isfahan
Province
Isfehan
Postal code
8184855351
Phone
+98 31 3236 7001
Fax
Email
info@manoshahr.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Khorasgan Branch (Isfahan)
Full name of responsible person
Ahmad Azin
Street address
, Arghavia, University Blvd، East Gay St
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Fax
+98 31 3535 4060
Email
info@khuisfac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Khorasgan Branch (Isfahan)
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Khorasgan (Isfahan) Branch, Islamic Azad University
Full name of responsible person
Fariba Khoshkam
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No.3, Prastoo Alay., Almohammad St., Chamran High way
City
Isfahan
Province
Isfehan
Postal code
8193713177
Phone
+98 31 3568 4210
Email
khoshkam7280@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khorasgan (Isfahan) Branch, Islamic Azad University
Full name of responsible person
Fariba Khoshkam
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No.3, Prastoo Alay., almohammad St., Chamran High way
City
Isfahan
Province
Isfehan
Postal code
8193713177
Phone
+98 31 3568 4210
Email
khoshkam7280@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
khorasgan Branch, Islamic Azad University, Isfahan, Iran
Full name of responsible person
Fariba Khoshkam
Position
student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 3, Parasto Alley., Al Mohammad St., Chamran High Way.,
City
Isfahan
Province
Isfehan
Postal code
8193713177
Phone
+98 31 3568 4210
Email
khoshkam7280@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available