Protocol summary

Study aim
The purpose of this study is to investigate the effect of eight weeks' anaerobic interval training on the Irisin, Insulin and lipid profiles of elderly men
Design
In this quasi-experimental pre-test/post-test study, in a public call with a special form and confirmation of attendance by a physician, 26 healthy men in Semnan who are voluntarily will be selected and participated in the present study. The subjects using NCSS PASS11 software, Procedure menu, DOE submenu, will be randomly divided into two groups of anaerobic interval training and the control group.
Settings and conduct
26 healthy men in Semnan who are voluntarily will be selected and participated in the present study.
Participants/Inclusion and exclusion criteria
The inclusion criteria is as follows: age range 58-70 years the ability to execute the training protocol, being committed to the program, Exclusion criteria were: regular physical activity at last 6 months ago (<1 session/week), taking alcohol and smoking and certain medications in the last 3 months (steroid drugs such as cortisol, nandrolone and ...).
Intervention groups
The intervention group performe anaerobic interval training, which included 10 repetitions of 20 seconds running, 70-80% heart rate and 80 second active rest between repetitions for eight weeks and six sessions per week. Exercise intensity will be determined by heart rate and controlled by the researcher using polar-pulse meter. In order to comply with the Overload Principle, one repetition to be added to the volume of exercise each week until the eighth week when the repetitions reached 17 times in each session. Control group will be conditions as same as intervention group.
Main outcome variables
plasma levels of irisin;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180912041018N1
Registration date: 2018-10-13, 1397/07/21
Registration timing: registered_while_recruiting

Last update: 2018-10-13, 1397/07/21
Update count: 0
Registration date
2018-10-13, 1397/07/21
Registrant information
Name
Rouhollah Haghshenas
Name of organization / entity
Semnan
Country
Iran (Islamic Republic of)
Phone
+98 23 3336 3494
Email address
rhm@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Eight Weeks Anaerobic Interval Training on Irisin, Insulin and Lipid Profiles in Elderly Men
Public title
Effect of Eight Weeks Anaerobic Interval Training on Irisin, Insulin and Lipid Profiles in Elderly Men
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Being committed to the program Age range 58-70 years Ability to execute the training protocol Committed to doing the program
Exclusion criteria:
perform regular exercise in 45 days ago are takeing certain medications in the last 3 months (Steroid drugs such as cortisone, nandrolone and ....) smoking and alcohol consumption Having acute illness (acute articular disease and bone softness, bone fractures)
Age
From 58 years old to 70 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
The subjects using NCSS PASS11 software, Procedure menu, DOE submenu, will be randomly divided into two groups
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
Ethics committee of semnan university of medical sciences
Street address
Standard Square
City
Semnan
Province
Semnan
Postal code
35131-19111
Approval date
2017-07-12, 1396/04/21
Ethics committee reference number
IR.SEMUMS.REC.1396.98

Health conditions studied

1

Description of health condition studied
aging
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Irisin serum level
Timepoint
before the start of the exercise protocol and 48 hours after the last exercise session, 5 ml of blood samples were taken from the ventricle of the left arm while sitting and after 12 o'clock fasting.
Method of measurement
To measure serum levels of Irisin, a special human-grade Irisin kit for the crystalline made in China was used with sensitivity of 0.1 μm and according to ELISA method and in accordance with the instructions for the kit.

Secondary outcomes

1

Description
Lipid profiles
Timepoint
before the start of the exercise protocol and 48 hours after the last exercise session, 5 ml of blood samples were taken from the ventricle of the left arm while sitting and after 12 o'clock fasting.
Method of measurement
Lipid profiles (LDL, HDL and FBS) were also measured using Pars Azmon kit.

Intervention groups

1

Description
Intervention group: The intervention group performed anaerobic interval training, which included 10 repetitions of 20 seconds running, 70-80% heart rate and 80 second active rest between repetitions for eight weeks and six sessions per week. Exercise intensity was determined by heart rate and controlled by the researcher using polar-pulse meter. The subjects initially began to warm up and stretch for seven minutes, and at the end they cooled down for five to ten minutes. In order to comply with the Overload Principle, one repetition was added to the volume of exercise each week until the eighth week when the repetitions reached 17 times in each session.
Category
Rehabilitation

2

Description
The control group was under routine care and had similar conditions to the intervention group without participating in the exercise protocol.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Semnan University of Medical Sciences
Full name of responsible person
Rouhollah Haghshenas
Street address
Standard Square
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3336 3494
Email
rhm@semnan.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University
Full name of responsible person
ali haghighi
Street address
Standard Square, Deputy of Research and Technology of Semnan University
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3365 4138
Email
Research.VC@semnan.ac.ir
Web page address
http://research.semnan.ac.ir/index.aspx?fkeyid=&siteid=3&pageid=3555
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University
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
Semnan University
Full name of responsible person
Rouhollah Haghshenas
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Standard Square
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3336 3494
Email
rhm@semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Rouhollah Haghshenas
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Standard Square
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3336 3494
Email
rhm@semnan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Rouhollah Haghshenas
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Standard Square
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3336 3494
Email
rhm@semnan.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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only the information of original outcome to be shared.
When the data will become available and for how long
6 month after published paper.
To whom data/document is available
Resercher
Under which criteria data/document could be used
For writing review article
From where data/document is obtainable
rhm@semnan.ac.ir
What processes are involved for a request to access data/document
After receiving mail
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