Protocol summary

Study aim
The purpose of this study was to investigate the effect of eight weeks of Pilates training on C-reactive protein, insulin resistance and body composition in middle-age obese women.
Design
In a randomized clinical trial design, twenty obese middle-aged women were randomly classified into two control and experimental groups.
Settings and conduct
All training sessions was performed under the supervision of an experienced physical trainer, and were conducted at the Mahabad islamic azad university athletic and fitness center in 2016.
Participants/Inclusion and exclusion criteria
Some of the inclusion criteria were obese middle-aged women with aged 35-50 years and without chronic diseases. Moreover, the criteria of exclusion were existence of any damage and uncontrolled intake of any supplement or drug.
Intervention groups
The experimental group participated in Pilates training three sessions a week for eight weeks, that each session lasting for 60 minute. While, control group did not do any special exercise.
Main outcome variables
For all subjects, body composition indexes, insulin resistance and C-reactive protein were assessed prior to and after training program.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120806010512N8
Registration date: 2018-05-10, 1397/02/20
Registration timing: retrospective

Last update: 2018-05-10, 1397/02/20
Update count: 0
Registration date
2018-05-10, 1397/02/20
Registrant information
Name
Sirvan Atashak
Name of organization / entity
Islamic Azad University-Mahabad Branch
Country
Iran (Islamic Republic of)
Phone
+98 44 2244 8301
Email address
s.atashak@iau-mahabad.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
2016-12-21, 1395/10/01
Actual recruitment end date
2017-03-15, 1395/12/25
Trial completion date
empty
Scientific title
Study of the effect of eight weeks of Pilates training on C-reative protein, insulin resistance and body composition in middle-age obese women
Public title
The effect of Pilates training on cardiovascular risk factors in obese women
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
aged 25-35years body mass index (BMI) equal or greater to 30 No current chronic health problems
Exclusion criteria:
Individuals with history of acute or chronic health conditions such as cardiovascular or other diseases those who used any drug medication
Age
From 35 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Actual sample size reached: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with flip the coin
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 the Mahabad Islamic Azad University
Street address
Islamic Azad University, Mahabad Branch, university Street
City
Mahabad
Province
West Azarbaijan
Postal code
5913933137
Approval date
2016-10-01, 1395/07/10
Ethics committee reference number
94/ IR.IAU.MAHABAD.REC.09210

Health conditions studied

1

Description of health condition studied
cardiovascular disease risk factors
ICD-10 code
Z50.1
ICD-10 code description
other physical therapy

Primary outcomes

1

Description
C-reactive Protein level
Timepoint
At the beginning of the study and prior of training and after training program
Method of measurement
The C-reactive Protein level was measured with the autoanalaizer and Diagnostics Biochem kites.

2

Description
insulin resistance index
Timepoint
At the beginning of the study and prior of training and after training program
Method of measurement
Insulin resistance was calculated via the homeostasis model assessment index (HOMA-IR) formula.

Secondary outcomes

1

Description
body composition indices
Timepoint
At the beginning of the study and prior of training and after training program
Method of measurement
The Waist to hip ratio (WHR) was calculated as waist circumference divided by that of the hip and Fat density (fat mass) was predicted from the skin-fold measurements taken using a caliper at the triceps, abdominal, and super iliac sites.

Intervention groups

1

Description
Intervention group: The experimental group participated in Pilates training three sessions a week for eight weeks, that each session lasting for 60 minute
Category
Lifestyle

2

Description
Control group: In the control group, participants were advised to maintain their normal lifestyle during the study and did not do any special exercise
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Mahabad Branch
Full name of responsible person
Dr Sirvan Atashak
Street address
University Street, , Islamic Azad University
City
Mahabad
Province
West Azarbaijan
Postal code
5913933137
Phone
+98 44 4244 5597
Email
s.atashak@iau-mahabad.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University of Mahabad
Full name of responsible person
Dr. Worya Karimi
Street address
Islamic Azad University., university Street
City
Mahabad
Province
West Azarbaijan
Postal code
5913933137
Phone
+98 44 4244 3000
Email
worya_karimi@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 of Mahabad
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 of Mahabad
Full name of responsible person
Dr Sirvan Atashak
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
University Street, Islamic Azad University
City
Mahabad
Province
West Azarbaijan
Postal code
5913933137
Phone
+98 44 4244 5597
Email
s.atashak@iau-mahabad.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Mahabad
Full name of responsible person
Dr Sirvan Atashak
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
University Street, Islamic Azad University
City
Mahabad
Province
West Azarbaijan
Postal code
5913933137
Phone
+98 44 4244 5597
Email
s.atashak@iau-mahabad.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Mahabad
Full name of responsible person
Dr Sirvan Atashak
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
University Street, Islamic Azad University
City
Mahabad
Province
West Azarbaijan
Postal code
5913933137
Phone
+98 44 4244 5597
Email
s.atashak@iau-mahabad.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are no such data in the present study
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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