Protocol summary

Summary
The purpose of this study was to survey effect of exercise training on serum levels of tumor necrosis factor-alpha, C-reactive protein, muscle strength, and cardio-respiratory function in inactive adolescent girls. To do this, forty six inactive (without experience of regular physical activity in one year before beginning of the study) adolescent (16-17 year) girls from Pakdasht city randomly are placed at four groups: strength, aerobic, concurrent, and control. General characteristics of subjects, serum levels of tumor necrosis factor-alpha, C-reactive protein, muscle strength, and cardio-respiratory function are evaluated before and after the training. Strength training protocol is consisted of eight weeks weight training (3 sessions per week, with intensity of 60-70% of one repetition maximum and duration of 25-55 min per each session). Aerobic training protocol is consisted of eight weeks aerobics (3 sessions per week, with intensity 60-75% of maximum heart rate and duration of 15-30 min per each session). Concurrent training protocol is combination of strength and aerobic training protocols.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014080618713N1
Registration date: 2014-09-07, 1393/06/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-07, 1393/06/16
Registrant information
Name
Viyan Vosoughi Baneh
Name of organization / entity
Islamic Azad University of Baneh
Country
Iran (Islamic Republic of)
Phone
+98 87 5426 0558
Email address
viyanvosoughi@iaubaneh.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Central Tehran
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2010-06-10, 1389/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of exercise training on serum levels of tumor necrosis factor-alpha, C-reactive protein, muscle strength, and cardio-respiratory function in inactive adolescent girls
Public title
Effect of exercise training in inactive adolescent girls
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Girl; adolescent (16-17 year); inactive (without experience of regular physical activity in one year before beginning 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 16 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
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 Baneh (Ethical Committee)
Street address
Islamic Azad University of Baneh
City
Baneh
Postal code
34679-66919
Approval date
2014-07-07, 1393/04/16
Ethics committee reference number
21-11-11-1680

Health conditions studied

1

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

Primary outcomes

1

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

2

Description
Body fat percent
Timepoint
Before and after the exercise training
Method of measurement
subcutaneous fat measurement

Secondary outcomes

1

Description
Tumor necrosis factor-alpha
Timepoint
Before and after the exercise training
Method of measurement
Determination of serum concentration

2

Description
C-reactive protein
Timepoint
Before and after the exercise training
Method of measurement
Determination of serum concentration

3

Description
Muscle strength
Timepoint
Before and after the exercise training
Method of measurement
Chest press and semi-squat

4

Description
Cardio-respiratory function
Timepoint
Before and after the exercise training
Method of measurement
maximal oxygen consumption measurement

Intervention groups

1

Description
Strength training protocol consisted of twelve weeks weight training in strength training group
Category
Other

2

Description
Aerobic training protocol consisted of twelve weeks aerobics in aerobic training group
Category
Other

3

Description
Concurrent training protocol consisted of twelve weeks weight training and aerobics in concurrent training group
Category
Other

4

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Moallem girls high school
Full name of responsible person
Street address
City
Pakdasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University of Central Tehran
Full name of responsible person
Hasan Matinhomaee
Street address
Exercise Physiology Department, Faculty of Physical Education and Sport Sciences, Iran Zamin Ave, Sanaat Sq.
City
Tehran
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 Central Tehran
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 Central Tehran
Full name of responsible person
Hasan Matinhomaee
Position
Ph. D of Exercise Physiology / Manager of Exercise Physiology Department
Other areas of specialty/work
Street address
Exercise Physiology Department, Faculty of Physical Education and Sport Sciences, Iran Zamin Ave, Sanaat Sq.
City
Tehran
Postal code
Phone
+98 912 368 0810
Fax
Email
hasanmatinhomaee@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Central Tehran
Full name of responsible person
Hamid Aghaalinezhad
Position
Ph. D of Exercise Physiology
Other areas of specialty/work
Street address
Exercise Physiology Department, Faculty of Physical Education and Sport Sciences, Iran Zamin Ave, Sanaat Sq.
City
Tehran
Postal code
Phone
+98 98912345882
Fax
Email
aghaalinejad@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Viyan Vosoughi Baneh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 989186507210
Fax
Email
viyanvosuqi@yahoo.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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