Protocol summary

Study aim
12 weeks of Interval Resistance Training with different intensities affects the levels of some selected adipokines in obese men.
Design
The present study is a quasi-experimental and applied method with a pre-test-post-test design with a control group. The samples will be divided into 4 groups based on demographic characteristics: control group (11 people), intervention group 1 (11 people), intervention 2 (11 people) and intervention 3 (11 people).
Settings and conduct
Two days before the start of the intervention period, initial assessments including anthropometric indices (height and weight and body mass index) of each subject will be measured in the gym. Resistance training protocol at different intensities in 12 weeks, 3 sessions per week, Each session will last 70 minutes. 48 hours before the start of the training program and 48 hours after the end of the last training session, all participants will fast for 12 hours to take a pre-test blood sample from the right arm artery. 10 cc will be collected.
Participants/Inclusion and exclusion criteria
Entry requirements: Body mass index = 30 No addiction to drugs and alcohol No history of regular exercise for at least 6 months No history of kidney, liver, cardiovascular disease, diabetes
Intervention groups
Intervention group 1: High intensity resistance circular training: 3 sets of 10 repetitions with 80% of a maximum repetition Intervention group 2: Circular resistance training with moderate intensity: 3 sets of 13 repetitions with 60% of a maximum repetition Intervention group 3: Low intensity resistance resistance training: 3 sets of 20 repetitions with 40% of a maximum repetition control group.
Main outcome variables
Toll Like Receptor4 (TLR4)، Toll Like Receptor4(TLR2) , Interleukin 10(IL-10), Interleukin 1 beta(IL-1beta), Dectin-1

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211123053155N1
Registration date: 2021-12-01, 1400/09/10
Registration timing: prospective

Last update: 2021-12-01, 1400/09/10
Update count: 0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Nader Najafi
Name of organization / entity
The University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 41 4333 3132
Email address
najafi.nader@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 12 weeks interval resistance training with different intensity on inflammatory and proinflammatory markers in obese men
Public title
Evaluation of The Effect ofResistance Training in obese people
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index = 30 No addiction to drugs and alcohol No history of regular exercise for at least 6 months No history of kidney, liver, cardiovascular disease, diabetes
Exclusion criteria:
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Group 1: High-intensity resistance training Group II: Medium-intensity resistance training Group 3: Low-intensity resistance training Group 4: Control

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mohaghegh Ardabili University
Street address
Mohaghegh Ardabil University, End of University Street
City
Ardabil
Province
Ardabil
Postal code
5619913131
Approval date
2021-11-06, 1400/08/15
Ethics committee reference number
IR.UMA.REC.1400.025

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Dectin-1
Timepoint
48 hours before and 48 hours after training intervention
Method of measurement
Equipment needed: Date disposable syringe, standard garo or tourniquet, test tube containing anticoagulant (EDTA), sterile cotton, 75% ethanol alcohol, Company ELISA kit (American) using ELISA device

2

Description
IL-10
Timepoint
48 hours before and 48 hours after training intervention
Method of measurement
Equipment needed: Date disposable syringe, standard garo or tourniquet, test tube containing anticoagulant (EDTA), sterile cotton, 75% ethanol alcohol, Company ELISA kit (Czech Republic) using ELISA device

3

Description
IL-1 beta
Timepoint
48 hours before and 48 hours after training intervention
Method of measurement
Equipment needed: Date disposable syringe, standard garo or tourniquet, test tube containing anticoagulant (EDTA), sterile cotton, 75% ethanol alcohol, Company ELISA kit (American) using ELISA device

4

Description
TRL2
Timepoint
48 hours before and 48 hours after training intervention
Method of measurement
Equipment needed: Date disposable syringe, standard garo or tourniquet, test tube containing anticoagulant (EDTA), sterile cotton, 75% ethanol alcohol, Company ELISA kit (American) using ELISA device

5

Description
TLR 4
Timepoint
48 hours before and 48 hours after training intervention
Method of measurement
Equipment needed: Date disposable syringe, standard garo or tourniquet, test tube containing anticoagulant (EDTA), sterile cotton, 75% ethanol alcohol, Company ELISA kit (American) using ELISA device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: High intensity slow training group: 3 sets of 10 repetitions with 80% of a maximum repetition. 12 weeks, 3 days a week, each session 70 minutes
Category
Prevention

2

Description
Intervention group 2: Medium intensity circular exercise group: 3 sets of 13 repetitions with 60% of a maximum repetition of 12 weeks, 3 days a week, each session 70 minutes
Category
Prevention

3

Description
Intervention group 3: Low intensity circular exercise group: 3 sets of 20 repetitions with 40% of a maximum repetition of 12 weeks, 3 days a week, each session 70 minutes
Category
Prevention

4

Description
Control group: No physical activity
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mohaghegh Ardabil University
Full name of responsible person
Nader Najafi
Street address
Mohaghegh Ardabil University, End of University Street
City
Ardabil
Province
Ardabil
Postal code
5619913131
Phone
+98 45 3150 5000
Email
najafinader22@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Mohaghegh Ardabil
Full name of responsible person
Davood Seifzadeh
Street address
Mohaghegh Ardabil University, End of University Street
City
Ardabil
Province
Ardabil
Postal code
5619913131
Phone
+98 45 3150 5000
Email
seifzadeh@uma.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 Mohaghegh Ardabil
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 Mohaghegh Ardabili
Full name of responsible person
Nader Najafi
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
No. 20 Farhang Alley ,Farhang Street
City
Bostan Abad
Province
East Azarbaijan
Postal code
5491718541
Phone
+98 41 4333 3132
Fax
Email
najafi.nader@uma.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Nader Najafi
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
No. 20 Farhang Alley ,Farhang Street
City
Bostan Abad
Province
East Azarbaijan
Postal code
5491718541
Phone
+98 41 4333 3132
Fax
Email
najafi.nader@uma.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Nader Najafi
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
No. 20 Farhang Alley ,Farhang Street
City
Bostan Abad
Province
East Azarbaijan
Postal code
5491718541
Phone
+98 41 4333 3132
Fax
Email
najafi.nader@uma.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 is no more information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The program protocol and informed consent are easily accessible to individuals
When the data will become available and for how long
After completing the research and publishing articles
To whom data/document is available
Academics and sports coaches
Under which criteria data/document could be used
According to the articles of this research, the use of training protocol is allowed.
From where data/document is obtainable
Email: najafinader22@gmail.com
What processes are involved for a request to access data/document
Please email and explain what research they need. Data is provided to them in a minimum of time.
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