Protocol summary

Summary
The purpose of this study is to evaluate the effects of three modes of training on serum level of irisin, myostatin, blood lipids, glucose homeostasis, physical fitness and body composition after 8 weeks of training in young girls. Inclusions criteria consist of 20-35 years normal and overweight inactivate girls and exclusion criteria will be include of absence for four sessions. In line with this, through the students of a faculty of Islamic Azad University of Rasht, 40 girls will be select and randomly assign into four groups and each group consist of 10 persons including: control, aerobic training, resistance training and concurrent training (aerobic-resistance). Subjects in the all training groups do exercise 3 times per week according to recommendations of American college of sport medicine. Fasting blood sample will be taken before and 24 hour after last training session, to evaluate Serum level of irisin, myostatin, blood lipids and glucose homeostasis concentration. Also, Subject’s physical fitness and body composition will be measured before and after the end of training period. The study duration will be 8 weeks and it seems that doing an aerobic, resistance or concurrent training, all can be effective on circulating irisin and myostatin levels, but the effect size will be different in the various types of training.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016123125449N2
Registration date: 2017-01-24, 1395/11/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-24, 1395/11/05
Registrant information
Name
Fatemeh Izaddoust
Name of organization / entity
Islamic Azad University Rasht Branch
Country
Iran (Islamic Republic of)
Phone
-
Email address
izaddoust@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
personality, Researcher
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of aerobic, resistance and concurrent training on Irisin, Myostatin, blood lipids, glucose homeostasis, Physical fitness and body composition in Inactive girls
Public title
The effect of exercise training on myokines and blood lipids
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: be girl; aged of 20-35 years; not have regular exercise training during last year; not have cardiovascular or orthopedic disease; have normal or overweight Exclusion criteria: absence for four sessions
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
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 Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Postal code
Approval date
2016-08-10, 1395/05/20
Ethics committee reference number
IR.IAU.RASHT.REC.1395.3

Health conditions studied

1

Description of health condition studied
healthy Inactive normal or overweight girls
ICD-10 code
Z72.3
ICD-10 code description
Lack of physical exercise

Primary outcomes

1

Description
myostatin
Timepoint
Before intervention and 24 hours after last training session
Method of measurement
serum levels using immunoassay method (ng/l)

2

Description
Irisin
Timepoint
Before intervention and 24 hours after last training session
Method of measurement
serum levels using immunoassay method (µg/ml)

3

Description
Cholesterol
Timepoint
Before intervention and 24 hours after last training session
Method of measurement
serum levels using photometric method (mg/dl)

4

Description
Triglyceride
Timepoint
Before intervention and 24 hours after last training session
Method of measurement
serum levels using photometric method (mg/dl)

5

Description
LDL
Timepoint
Before intervention and 24 hours after last training session
Method of measurement
serum levels using enzymatic method (mg/dl)

6

Description
HDL
Timepoint
Before intervention and 24 hours after last training session
Method of measurement
serum levels using enzymatic method (mg/dl)

7

Description
Added at 2017-01-24: Insulin resistance
Timepoint
Added at 2017-01-24: before and after training period
Method of measurement
Added at 2017-01-24: using HOMA method

8

Description
Added at 2017-02-26: Insulin
Timepoint
Added at 2017-02-26: Before intervention and 24 hours after last training session
Method of measurement
Added at 2017-02-26: serum levels using immunoassay method (pmol/l)

9

Description
Added at 2017-02-26: Fast blood Sugar
Timepoint
Added at 2017-02-26: Before intervention and 24 hours after last training session
Method of measurement
Added at 2017-02-26: serum levels using photometric method (mg/dl)

Secondary outcomes

1

Description
VO2max
Timepoint
Before and after training period
Method of measurement
using Bruce Treadmill test (ml/kg/min)

2

Description
steight
Timepoint
Before and after training period
Method of measurement
using 1RM test (kg)

3

Description
Added at 2017-01-24: Body composition
Timepoint
Added at 2017-01-24: before and after training period
Method of measurement
Added at 2017-01-24: using body mass index and waist to hip ratio

Intervention groups

1

Description
control group Continued their usual activities
Category
Other

2

Description
Aerobic training 8 weeks, 3 sessions per week, each session 65 min (10 min warm up, 50 min aerobic training and 5 min cool down), using 65-75 Percent of maximum heart rate (220-age)
Category
Other

3

Description
resistance training 8 weeks, 3 sessions per week, each session 65 min (10 min warm up, 50 min resistance training, 5 min cool down), using 65-75 percent of 1RM, 2-4 set, 9 training, 8-12 repetition with 30-60 min rest interval between sets, 2-3 min between movments
Category
Other

4

Description
concurrent training 8 weeks, 3 sessions per week, each session 65 min (10 min warm up, 25 min resistance training, 25 min aerobic training and 5 min cool down)
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University Rasht branch
Full name of responsible person
Street address
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Rasht Branch
Full name of responsible person
Fatemeh Izaddoust
Street address
Islamic Azad University Rasht Branch, Taleshan Bredge
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Rasht Branch
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 Rasht Branch
Full name of responsible person
Fatemeh Izaddoust
Position
Master's Degree Student
Other areas of specialty/work
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge
City
Rasht
Postal code
Phone
+98 13 3385 6174
Fax
Email
shabani@iaurasht.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Rasht Branch
Full name of responsible person
Dr Ramin shabani
Position
Associate professor
Other areas of specialty/work
Street address
Islamic Azad University Rasht Branch, Taleshan Brige
City
Rasht
Postal code
Phone
+98 13 3385 6174
Fax
Email
fa.izaddoust@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad Univercity Rasht Branch
Full name of responsible person
Fatemeh Izaddoust
Position
Master's Degree Student
Other areas of specialty/work
Street address
Islamic Azad Univercity Rasht Branch, Taleshan Bridge
City
Rasht
Postal code
Phone
+98 133828682
Fax
Email
shadirostami.sr@gmail.com
Web page address

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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