Protocol summary

Summary
The purpose of present study is to investigate the effect of endurance training on adipokines leptin and chemerin in inactive lean men. To do this, twenty inactive (without experience of regular physical activity in one year before beginning of the study) lean (body mass index less than 18.5 kilogram/meter squared) men from cities Boukan and Saghez randomly are placed at two groups: endurance training and control. General characteristics of subjects and serum concentration of leptin and chemerin are evaluated before and after the training. Endurance training protocol is consisted of twelve weeks pedaling on cycle ergometer (3 sessions per week, intensity 60-70% of reserved heart rate, duration of each session 20-40 min).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014090410158N4
Registration date: 2014-10-04, 1393/07/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-04, 1393/07/12
Registrant information
Name
Fatah Moradi
Name of organization / entity
Islamic Azad University of Saghez
Country
Iran (Islamic Republic of)
Phone
+98 87 3630 5049
Email address
moradi_fatah@iausaghez.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Saghez
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2010-04-21, 1389/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of endurance training on adipokines leptin and chemerin in inactive lean men
Public title
Effect of endurance training in lean men
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Male; lean (body mass index less than 18.5 kilogram/meter squared); 18-30 year; without experience of regular physical activity in one year before begining of the study; Exclusion criteria: history of cardiovascular diseases; diabetes; thyroid diseases; drug consumption; being under any diet or medication; addiction to any narcotic substances; smoking; alcoholism; caffeine.
Age
From 18 years old to 38 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
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
Islamic Azad University of Saghez (Ethical Committee)
Street address
Islamic Azad University of Saghez
City
Saghez
Postal code
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
11-16-1-4747

Health conditions studied

1

Description of health condition studied
Lean
ICD-10 code
E-90
ICD-10 code description
Nutritional and metabolic disorders in diseases classified elsewhere

Primary outcomes

1

Description
Body weight
Timepoint
Before and after the endurance training
Method of measurement
Digital weighing machine

Secondary outcomes

1

Description
serum concentration of leptin
Timepoint
Before and after the endurance training
Method of measurement
Determination of serum concentration

2

Description
serum concentration of chemerin
Timepoint
Before and after the endurance training
Method of measurement
Determination of serum concentration

Intervention groups

1

Description
Endurance training protocol consisted of twelve weeks pedaling on cycle ergometer in endurance training group
Category
Other

2

Description
Continuing daily living without doing regular physical activity in control group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University of Saghez
Full name of responsible person
Street address
City
Saghez

2

Recruitment center
Name of recruitment center
Islamic Azad University of Boukan
Full name of responsible person
Street address
City
Boukan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University of Saghez
Full name of responsible person
Dr. M. Salar Tarkhami
Street address
Islamic Azad University of Saghez
City
Saghez
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Saghez
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 Saghez
Full name of responsible person
Soran Heydari
Position
Manager of physical education and sport sciences department
Other areas of specialty/work
Street address
Islamic Azad University of Saghez
City
Saghez
Postal code
Phone
+98 918 874 9691
Fax
Email
soranheidari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Saghez
Full name of responsible person
Dr. Fatah Moradi
Position
Ph. D of Exercise Physiology
Other areas of specialty/work
Street address
Islamic Azad University of Saghez
City
Saghez
Postal code
Phone
+98 914 482 3733
Fax
Email
moradi_fatah@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr. Fatah Moradi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 914 482 3733
Fax
Email
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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