Protocol summary

Summary
The aim of this study was to determine the effect of 8 weeks of Pilates exercise on serum Visfatin levels, (the homeostatic model assessment-insulin resistance) HOMA-IR index, (the homeostatic model assessment-beta-cell) HOMA-β Cell Index in overweight and obese women. For this reason, 20 overweight and obese healthy and non-athletic women without any illness will voluntarily participate in the research and will be divided into two groups: experimental and control groups. The experimental group will take place in a Pilates training program for eight weeks with an intensity of 40 to 60 percent of maximum heart rate, three times a week and each session will take an hour. The control group will not perform any exercises. In order to measure serum Visfatin and Insulin level and HOMA-IR & HOMA-β indices, fasting blood samples of two groups will be collected 24 hours before the start of exercise and 24 hours after the last exercise session. Also, before and after performing Pilates training, body mass index, body weight and waist to hip ratio will be measured in two groups. Finally, we will compare the mentioned variables between and within groups in order to clarify the effect of Pilates training on above variables.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017030432873N1
Registration date: 2017-04-10, 1396/01/21
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Farzad Zehsaz
Name of organization / entity
Islamic azad University, Tabriz Branch
Country
Iran (Islamic Republic of)
Phone
+98 41 3196 6245
Email address
f-zehsaz@iaut.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-04-14, 1396/01/25
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of eight weeks of Pilates exercise on serum visfatin levels, the HOMA-IR شدی HOMA-β indices in overweight and obese women
Public title
The effects of exercise training on HOMA-IR index in obese women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Non-athletic women; being obese and over weight; Regular menstruation; exposure to early stage of follicular period; age range 25-40 years old; Exclusion criteria: having any illness
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
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
Islamic Azad University,Tabriz Branch
Street address
Islamic Azad University, Tabriz Branch, Tabriz, Iran
City
Tabriz
Postal code
-
Approval date
2016-10-24, 1395/08/03
Ethics committee reference number
IR.IAU.TABRIZ.REC.1395.4

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
E66.9

Primary outcomes

1

Description
Insulin
Timepoint
Before intervention and after 8 weeks of the begining of intervention
Method of measurement
IU/mL & Blood sampling

2

Description
Glucose
Timepoint
Before intervention and after 8 weeks of the begining of intervention
Method of measurement
mg/dL & Blood sampling

3

Description
Visfatin
Timepoint
Before intervention and after 8 weeks of the begining of intervention
Method of measurement
mg/mL & Blood sampling

Secondary outcomes

1

Description
HOMA-β
Timepoint
Before intervention and after 8 weeks of the begining of intervention
Method of measurement
Blood Sampling and putting glucose and insulin levels in formula

2

Description
HOMA-IR
Timepoint
Before intervention and after 8 weeks of the begining of intervention
Method of measurement
Blood Sampling and putting glucose and insulin levels in formula

Intervention groups

1

Description
The experimental group participated in a Pilates training program for eight weeks with an intensity of 40 to 60 percent of maximum heart rate, three times a week and each session took an hour. The control group did not perform any exercises.
Category
Lifestyle

2

Description
Pilates exercise training
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Youth and Sport Office
Full name of responsible person
-
Street address
Tabriz Pilates Clubs
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Nasrin Jahanyar
Street address
Physical Education Department, Islamic Azad University of Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic azad University of Tabriz
Full name of responsible person
Farzad Zehsaz
Position
Academic Staff Member
Other areas of specialty/work
Street address
Islamic azad University of Tabriz
City
Tabriz
Postal code
Phone
+98 914 417 6472
Fax
Email
f-zehsaz@iaut.ac.ir; farzadzehsaz@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic azad University of Tabriz
Full name of responsible person
Farzad Zehsaz
Position
Academic Staff University
Other areas of specialty/work
Street address
Islamic azad University of Tabriz
City
Tabriz
Postal code
Phone
+98 914 417 6472
Fax
Email
f-zehsaz@iaut.ac.ir; farzadzehsaz@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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