Protocol summary

Study aim
Reviews of weight loss and appetite changes resulting from regular sports exercises
Design
The present study is a randomized clinical trial and the subjects are assigned in the pretest-posttest design with the control group.Subjects randomly are divided into two groups including resistance training group (n=15, perform 7 resistance exercises, 4 sets, 8 repetitions with 80% of one repetition maximum) and the control group (n=15, without any regular exercise training). experimental (training) group will perform 6- months exercise training protocol, 3 sessions per week, each session 1 hour.
Settings and conduct
This study is the semi- experimental and will be conducted in the city of javanrud. The experimental group will perform training in Imam Khomeini cloub and blood sampling from each of the two groups will perform in the Hazrat Rasoul hospital laboratories in javanrud city .
Participants/Inclusion and exclusion criteria
Entry requirements include:18>Age>50- Obesity (a body mass index above 30 kg/m2)-Having an informed consent for participation in the study Conditions of non-entry:Gender(Women can not be selected as an example) - having illness and taking drugs and supplements - drug and alcohol addiction - having regular exercise in past 6 months
Intervention groups
In this study, resistance training group (n=15, perform 7 resistance exercises, 4 sets, 8 repetitions with 80% of one repetition maximum and the control group (n=15, without any regular exercise training). training group will perform 6- month exercise training protocol, 3 sessions per week, each session 1 hour.
Main outcome variables
Dependent variable :Weight, BMI ,appetite related hormones change includs: Acylated Ghrelin , PYY, Orexin and Insulin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180708040392N1
Registration date: 2018-08-07, 1397/05/16
Registration timing: prospective

Last update: 2018-08-07, 1397/05/16
Update count: 0
Registration date
2018-08-07, 1397/05/16
Registrant information
Name
Naser Rostamzadeh
Name of organization / entity
The University of Kurdestan
Country
Iran (Islamic Republic of)
Phone
+98 87 3371 1530
Email address
n.rostamzadeh@hum.uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 2 ,4 and 6 month periods of resistance training and detraining on appetite-regulating hormones in obese men
Public title
The effect of resistance training and detraining on appetite-regulating hormones
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
18<Age<50 BMI>30 kg/m2 Having an informed consent for participation in the study
Exclusion criteria:
Gender (Women can not be selected as an example) People who have a certain disease and take medication Having a regular sports activity during past 6 months Having drug addiction and smoking
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple method to draw an accident:The researcher assigns a number to each of the samples, then they are selected using the random number table or the computer model and randomly assigned to one of the groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Street, Central Room of Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6791653379
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.KUMS.REC.1397.204

Health conditions studied

1

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

Primary outcomes

1

Description
obesity
Timepoint
Before starting the protocol and again after one session training , 2 months training, 4 months training, 6 months training and 2 week subsequent detraining
Method of measurement
measure of Body Mass Index ( BMI )

2

Description
Accylated Ghrelin
Timepoint
Before starting the protocol and again after one session training , 2 months training, 4 months training, 6 months training and 2 week subsequent detraining
Method of measurement
Serum ELISA Kit

3

Description
PYY
Timepoint
Before starting the protocol and again after one session training , 2 months training, 4 months training, 6 months training and 2 week subsequent detraining
Method of measurement
Serum ELISA Kit

4

Description
Orexin
Timepoint
Before starting the protocol and again after one session training , 2 months training, 4 months training, 6 months training and 2 week subsequent detraining
Method of measurement
Serum ELISA Kit

5

Description
Insulin
Timepoint
Before starting the protocol and again after one session training , 2 months training, 4 months training, 6 months training and 2 week subsequent detraining
Method of measurement
Serum ELISA Kit

Secondary outcomes

1

Description
The amount of calorie intake
Timepoint
In six steps include: a pre - test (before starting the intervention) and then a five step post -test (after a one session and 2, 4, 6 months training , and after 2 weeks of detraining
Method of measurement
by remember food intake form

Intervention groups

1

Description
Intervention group: do resistance training for 6 months and 2 weeks subsequnet detraining
Category
Lifestyle

2

Description
Control group: This group does not receive any intervention and only participates in measurements
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Kurdestan
Full name of responsible person
Naser Rostamzadeh
Street address
No.1, Zibashahr Ave., Baharan Town
City
Sanandaj
Province
Kurdistan
Postal code
6617883357
Phone
+98 87 3371 1530
Email
n.rostamzadeh@hum.uok.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Kurdestan
Full name of responsible person
Shamseddin Ahmadi
Street address
University of Kurdistan, Pasdaran, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3362 4001
Email
sh.ahmadi@uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Kurdestan
Proportion provided by this source
100
Public or private sector
Public
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
The University of Kurdestan
Full name of responsible person
Naser Rostamzadeh
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
No.1,Zibashahr Ave., Baharan Town
City
Sanandaj
Province
Kurdistan
Postal code
6617883357
Phone
+98 87 3371 1530
Email
n.rostamzadeh@hum.uok.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Kurdestan
Full name of responsible person
Naser Rostamzadeh
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
No.1, Zibashahr Ave., Baharan Town
City
Sanandaj
Province
Kurdistan
Postal code
6617883357
Phone
+98 87 3371 1530
Email
n.rostamzadeh@hum.uok.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Kurdestan
Full name of responsible person
Naser Rostamzadeh
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
No. 1, Zibashahr Ave., Baharan Town
City
Sanandaj
Province
Kurdistan
Postal code
6617883357
Phone
+98 87 3371 1530
Email
n.rostamzadeh@hum.uok.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Part of the data, such as average age, gender,the average of the body mass index and results of the outcome have the possibility of sharing
When the data will become available and for how long
6 months after the print results
To whom data/document is available
Researcher people in Academic and scientific institutions
Under which criteria data/document could be used
Just to compare with similar research using the documentation permitted
From where data/document is obtainable
By email
What processes are involved for a request to access data/document
After you send the request via e-mail, lasts for 2 months
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