Protocol summary

Summary
The purpose of the present was to comparison of combined exercising on body composition and blood lipid profile of obese and overweight. The population of this research was includes high school students (13 to 15 years) that 40 subjects (20 obese and 20 have a greater score) were selected and were randomly divided into two groups of, experimental(10 people) and control group(10 people). Inclusion criteria are: Lack exercise training in one years a go; Maximum age 13-15 years. exclusion criteria are: Patients with Acute cardiovascular disease and Joint and bone diseases.Then the obese and overweight group randomly divided into two groups of 10 people, experimental and control group. Fasting blood samples were collected from each group in a week before starting an exercise program. The exercise conducted about 12 week for 90 minutes. Strength training started with 50% 1RM and increased to 80% 1RM and endurance training started from 50 percent and reached to 80 percent of maximum heart rate. Body composition and Blood samples such as Blood glucose homeostasis and lipid were evaluated before and after practice.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015122222498N6
Registration date: 2016-08-02, 1395/05/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-02, 1395/05/12
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Rasht, Science and Research Branch
Expected recruitment start date
2015-03-15, 1393/12/24
Expected recruitment end date
2015-08-21, 1394/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of a period combination resistance-endurance exercise training on body composition, blood lipid profile, and blood glucose homeostasis in overweight and obese high school girls
Public title
Comparison the effect of a period combination resistance-endurance exercise training on body composition, blood lipid profile, and blood glucose homeostasis in overweight and obese high school girls
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are: Lack exercise training in one years a go; Maximum age 13-15 years. exclusion criteria are: Patients with Acute cardiovascular disease and Joint and bone diseases
Age
From 13 years old to 15 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was performed using to sealed envelopes.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Rasht, Science and Research Branch
Street address
Lakan Gate, Azad University, Rasht Branch, Rasht
City
Rasht
Postal code
4147654919
Approval date
2015-04-25, 1394/02/05
Ethics committee reference number
61321404932014

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity and other hyperalimentation

Primary outcomes

1

Description
fasting blood glucose (FBS)
Timepoint
before and after 12 weak exercise
Method of measurement
According mg/dl and Blood samples

2

Description
Insulin resistance
Timepoint
before and after 12 weak exercise
Method of measurement
It was measured with HOMA-IR index

3

Description
Insulin
Timepoint
before and after 12 weak exercise
Method of measurement
According mg/dl and Blood samples

4

Description
triglycerides
Timepoint
before and after 12 weak exercise
Method of measurement
According mg/dl and Blood samples

5

Description
Total Cholesterol
Timepoint
before and after 12 weak exercise
Method of measurement
According mg/dl and Blood samples

6

Description
High-density lipoprotein
Timepoint
before and after 12 weak exercise
Method of measurement
According mg/dl and Blood samples

7

Description
Low-density lipoprotein
Timepoint
before and after 12 weak exercise
Method of measurement
According mg/dl and Blood samples

8

Description
Glycosylated hemoglobin
Timepoint
before and after 12 weak exercise
Method of measurement
According mg/dl and Blood samples

Secondary outcomes

1

Description
Weight
Timepoint
before and after 12 weak exercise
Method of measurement
According to kilograms and by balance

2

Description
Body mass index
Timepoint
before and after 12 weak exercise
Method of measurement
According to Kg/m2 and dividing body weight by the square of the height(m2)

3

Description
Subcutaneous fat
Timepoint
before and after 12 weak exercise
Method of measurement
By caliper

4

Description
Body Fat Percentage
Timepoint
before and after 12 weak exercise
Method of measurement
By caliper

Intervention groups

1

Description
The experimental group did combined training (strength and endurance). The exercise conducted about 12 week for 90 minutes.Endurance training was with Intensity 50 to 80 percent heart rate. Training did on bike and treadmill. Resistance training was with 50 to 70 percent heart rate.
Category
Lifestyle

2

Description
Control group was without practice
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Education
Full name of responsible person
Zohreh Jalali
Street address
Lakan, Rasht
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University, Rasht, Science and Research Branch
Full name of responsible person
Dr.Ramin Shabani
Street address
Lakan Gate, Azad University, Rasht Branch
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Islamic Azad University, Rasht, Science and Research Branch
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, Rasht Branch
Full name of responsible person
Marzieh Nazari
Position
MA
Other areas of specialty/work
Street address
Lakan gate, Azad University, Rasht Branch, Rasht, Guilan
City
Rasht
Postal code
Phone
+1 333423308
Fax
Email
m_nazari1390@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Of Rasht Branch
Full name of responsible person
Dr.Ramin Shabani
Position
PhD
Other areas of specialty/work
Street address
Lakan Gate, Islamic Azad University, Rasht Branch, Rasht
City
Rasht
Postal code
Phone
+1 333423308
Fax
Email
shabani_msn@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad Universit Of Rasht Branch
Full name of responsible person
Marzieh Nazari
Position
MA
Other areas of specialty/work
Street address
Lakan Gate,Islamic Azad University, Rasht Branch, Guilan
City
Rasht
Postal code
Phone
00
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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