Protocol summary

Study aim
The aim of this study was to compare the effects of linear (LP) and nonlinear (NLP) RT on serum myokines levels, fluid balance and functional capacity in overweight/obese women.
Design
The trained groups performed 3 weekly sessions for 12 weeks of resistance training with different of periodization. While the control group will continue their inactive lifestyle.
Settings and conduct
This is a blind study conducted at the University of Medical Sciences.
Participants/Inclusion and exclusion criteria
The subjects in the present study are non-athletic women with overweight / obesity, age range of 28-46, non-postmenopausal, non-disease, non-smoker, without a specific diet.
Intervention groups
In this study, we have two training groups and one control group.
Main outcome variables
Serum levels of interleukin-7, interleukin-15, insulin-like growth factor, insulin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121204011670N3
Registration date: 2018-03-12, 1396/12/21
Registration timing: retrospective

Last update: 2018-03-12, 1396/12/21
Update count: 0
Registration date
2018-03-12, 1396/12/21
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
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2017-11-22, 1396/09/01
Trial completion date
empty
Scientific title
Effects of linear and daily undulating periodized resistance training on serum myokines levels, fluid balance, body composition and functional capacity in untrained women
Public title
myokines and resistance training
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Untrained women maximal oxygen uptake (VO2max, 31–42 ml/kg/min) age (28–46 years) body mass index (26–32 kg/m2)
Exclusion criteria:
trained subjects having any kind of disease the consumption of alcohol the consumption of cigarettes having eating unusual
Age
From 28 years old to 46 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method
Blinding (investigator's opinion)
Single blinded
Blinding description
Training groups in the study are two different methods without the knowledge of other groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences
Street address
Postcode: 6939177143, Department of Medicine, Ilam University of Medical Sciences, Blvd. Pajohesh, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2018-02-13, 1396/11/24
Ethics committee reference number
ir.medilam, 1396.127

Health conditions studied

1

Description of health condition studied
untrained women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum levels of interleukin-7
Timepoint
before and after 12 weeks of training
Method of measurement
enzyme-linked immunosorbent assay

2

Description
Serum levels of Interleukin-15
Timepoint
before and after 12 weeks of training
Method of measurement
enzyme linked immunosorbent assay (ELISA)

3

Description
insulin like growth factor-1
Timepoint
before and after 12 weeks of training
Method of measurement
enzyme linked immunosorbent assay (ELISA)

4

Description
body composition
Timepoint
before and after 12 weeks of training
Method of measurement
Bio-impedance

Secondary outcomes

1

Description
fluid balance
Timepoint
before and after 12 weeks of training
Method of measurement
Bio-Impedance method

2

Description
aerobic capacity
Timepoint
before and after 12 weeks of training
Method of measurement
One-step test on the treadmill

Intervention groups

1

Description
Intervention group: Non-linear resistance training (12 weeks, three times a week for about an hour each session)
Category
Rehabilitation

2

Description
Intervention group: linear resistance training (12 weeks, three times a week for about an hour each session)
Category
Rehabilitation

3

Description
Control group: This group will maintain their sedentary lifestyle during the study period
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University of Ilam Branch
Full name of responsible person
Nikseresht Mahmoud
Street address
Ilam Branch, Ilam Islamic Azad University, Ilam
City
Ilam
Province
Ilam
Postal code
6931133145
Phone
+98 84 3222 7531
Email
nikseresht@ilam-iau.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Hafezi-Ahmadi Mohammadreza
Street address
Postcode: 6939177143, Department of Medicine, Ilam University of Medical Sciences, Blvd. Pajohesh, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3333 4060
Email
reza.ahmadi56@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University of Medical Sciences
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
Islamic Azad University
Full name of responsible person
Nikseresht Mahmoud
Position
Asisstant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Postal code: 6931133145, Department of Sport Sciences, Ilam Branch, Islamic Azad University, Daneshjo Blvd., Ilam, Iran
City
Ilam
Province
Ilam
Postal code
0098 6931133145
Phone
+98 84 3222 7526
Email
nikseresht@ilam-iau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nikseresht Mahmoud
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Postcode: 6939177143, Department of Sport Sciences, Ilam Branch, Islamic Azad University, Daneshjo Boulevard, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
6931133145
Phone
+98 84 3222 7526
Email
nikseresht@ilam-iau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nikseresht Mahmoud
Position
Assistant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Postcode: 6939177143, Department of Sport Sciences, Ilam Branch, Islamic Azad University, Daneshjo Boulevard, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
6931133145
Phone
+98 84 3222 7526
Email
nikseresht@ilam-iau.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of this study will be published after statistical analysis
When the data will become available and for how long
One year after data collection
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Corresponding Author
What processes are involved for a request to access data/document
About one month after request
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