Protocol summary

Summary
The purpose of this study is to evaluate the effects of 12 weeks of nonlinear resistance (non-RT) and intensive aerobic interval training (AIT) on serum cytokines levels and insulin resistance index in sedentary obese men. Forty-five healthy men were randomly assigned to three groups of AIT (n= 15), non-RT (n=15) and control group (n= 15). Blood samples from subjects will be taken for measurement of interleukin-6, interleukin-18, insulin, glucose and lipid profile before and after training.The experimental groups will be performed three weekly sessions for 12 weeks (non-RT: consisted of performing weight training with different intensities and volumes, AIT: consisted of running on a treadmill, four times 4 min at 80-90% of maximal heart rate, with a 3-min jog in between). To determine the significance of AIT, non-RT, time (before and after 12 weeks) and the interaction between the training and time on dependent variables, two-way ANOVA will be used. Also, Bonferroni method will be used for comparison between groups. Pearson and Spearman correlation coefficient will be determined for relationship between the variables before and after the training.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012120911670N2
Registration date: 2013-02-10, 1391/11/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-02-10, 1391/11/22
Registrant information
Name
Mahmoud Nikseresht
Name of organization / entity
Islamic Azad University of Ilam
Country
Iran (Islamic Republic of)
Phone
+98 918 343 3019
Email address
nikseresht@ilam-iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute of Endocrine Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effects of three months nonlinear resistance and high intensity aerobic interval training on interleikin-6, 18 and insulin resistance index in sedentary obese men
Public title
The effcts of exercise training on cytokines
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: healthy men, aged 34-48 years, sedentary, nonsmoker, no drugs or alcohol, no having regular exercise in the past six months, and obese. Exclusion criteria: Completing exercise training less than 80% of the training sessions for experimental group.
Age
From 34 years old to 48 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Institute of Endocrine Sciences
Street address
No. 24, Parvaneh st., Yemen St., Velenjak, Chamran Highway
City
Tehran
Postal code
1985717413
Approval date
2012-11-27, 1391/09/07
Ethics committee reference number
35ECRIES

Health conditions studied

1

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

Primary outcomes

1

Description
Insulin resistance index
Timepoint
Before and after 12 wk of intervention
Method of measurement
ELISA

2

Description
Interleukin-6
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA

3

Description
Interleukin-18
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA

Secondary outcomes

1

Description
Body fat percent
Timepoint
Before and after the 12 weeks of training
Method of measurement
Caliper

2

Description
VO2max
Timepoint
Before and after the 12 weeks of training
Method of measurement
Bruce test

Intervention groups

1

Description
Intensive aerobic interval training
Category
Prevention

2

Description
Nonlinear resistance training
Category
Prevention

3

Description
Control
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University of Ilam
Full name of responsible person
Dr. Mahmoud Nikseresht
Street address
Islamic Azad University of Ilam, Daneshjo Ave.
City
Ilam

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute of Endocrine Sciences
Full name of responsible person
Dr. Farhad Hosseinpanah
Street address
No. 24 , Parvaneh st., Yemen St., Chamran Highway, Velenjak
City
Tehran
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute of Endocrine Sciences
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 Ilam
Full name of responsible person
Dr. Mahmoud Nikseresht
Position
Assistant
Other areas of specialty/work
Street address
Islamic Azad University of Ilam, Daneshjo Blvd.
City
Ilam
Postal code
6931133145
Phone
+98 84 2432 3260
Fax
+98 84 2422 3566
Email
nikserasht@gmai.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Ilam
Full name of responsible person
Dr. Mahmoud Nikseresht
Position
Assistant
Other areas of specialty/work
Street address
Islamic Azad University of Ilam, Daneshjo Blvd., Ilam
City
Ilam
Postal code
6931133145
Phone
+98 84 2432 3260
Fax
+98 84 2422 3566
Email
nikserasht@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of ilam
Full name of responsible person
Dr. Mahmoud Nikseresht
Position
Enforcer
Other areas of specialty/work
Street address
Islamic Azad University of ilam, Daneshjo Blvd.
City
Ilam
Postal code
6931133145
Phone
+98 84 1222 7526
Fax
+98 84 2422 3566
Email
Nikserasht@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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