Effect of a course of sport exercises with different intensities on body composition and brown fat indices in obese and overweight women.
Design
The 12-week training program in experimental groups 1 to 3 included heavy running from 77 to 93, a moderate intensity of 64 to 76, and a light intensity of 50 to 63 percent of heart rate at a maximum of three sessions per week. A sample of 50 people who were randomly (The method of tracking) assigned to 4 groups( experimental groups:13, control group:11).Before and after the training period, Irisine, FGF21 and Mayostatin serum samples were taken from all subjects in fasting state., Anthropometric measurements were also performed.
clinical trial type: randomized clinical trial with control group
Settings and conduct
The training program is 12 weeks and three sessions a week.The place of the study is the sports hall in Bojnurd city.Subjects will be running in the designated range of heart rates by attending at the gym (5 o'clock).
Participants/Inclusion and exclusion criteria
50 volunteers (mean age: 40/2 ±3/25 years; weight 75/71± 5/71 kg; height 1/61 ± 0/05 m); age range of 35 to 45 years; non-inclusion criteria; Medication or change in diet, cardiovascular disease, having regular physical activity and the criteria for regular menstrual periods 12 months ago and having a body mass greater than 25 kg / m2
Intervention groups
Intervention group 1: interval training with heavy intensity,Intervention group 2: interval training with moderate intensity ,Intervention group 3: interval training with light intensity، control group:Untreated group
Main outcome variables
Irisin; Myostatin; FGF21
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040464N1
Registration date:2018-09-06, 1397/06/15
Registration timing:retrospective
Last update:2018-09-06, 1397/06/15
Update count:0
Registration date
2018-09-06, 1397/06/15
Registrant information
Name
Zeynab Firozeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3228 7930
Email address
zfirozeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2018-02-20, 1396/12/01
Actual recruitment end date
2018-05-21, 1397/02/31
Trial completion date
2018-08-22, 1397/05/31
Scientific title
The effect of exercise training with different intensities on body composition and brown adipose tissue markers in obese and over weight women
Public title
The effect of exercise training on body composition and brown adipose tissue markers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
having regular menstruation 12 months ago
having a body mass greater than 25 kg / m2
Exclusion criteria:
Menopause
Sickness
Tobacco use
use of medication or change in diet
having regular physical activity
Age
From 35 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method.
The method of tracking was used.Each name dropped out of the container in
light, medium, heavy and control groups, respectively.
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
National Ethics Committee in Biomedical Research of Hakim Sabzevari University
Street address
Tohid shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Approval date
2018-05-12, 1397/02/22
Ethics committee reference number
IR.HSU.REC.1397.002
Health conditions studied
1
Description of health condition studied
obesity , overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Irisin
Timepoint
First and 12 weeks later
Method of measurement
ELISA laboratory method
2
Description
Fibroblast growth factor 21(FGF21)
Timepoint
First and 12 weeks later
Method of measurement
ELISA laboratory method
3
Description
Myostatin
Timepoint
First and 12 weeks later
Method of measurement
ELISA laboratory method
Secondary outcomes
1
Description
maximal oxygen consumption(VO2max)
Timepoint
First and 12 weeks later
Method of measurement
Rockport
2
Description
Body Mass Index(BMI)
Timepoint
First and 12 weeks later
Method of measurement
Digital scales and meters
3
Description
Waist–hip ratio (WHR)
Timepoint
First and 12 weeks later
Method of measurement
Meters
4
Description
Body fat percentage
Timepoint
First and 12 weeks later
Method of measurement
Caliper
Intervention groups
1
Description
Intervention group: heavy interval training-Three times a week - 12 weeks - with an intensity of 77-93% of maximum heart rate- Duration of activity from the beginning to the end of the protocol (25 to 65 minutes)
Category
Other
2
Description
Intervention group: medium interval training-Three times a week - 12 weeks - with an intensity of 64-76% of maximum heart rate- Duration of activity from the beginning to the end of the protocol (25 to 65 minutes)
Category
Other
3
Description
Intervention group: low interval training-Three times a week - 12 weeks - with an intensity of50-63% of maximum heart rate- Duration of activity from the beginning to the end of the protocol (25 to 65 minutes)
Category
Other
4
Description
Control group: Lack of exercise within 12 weeks
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
bojnourd Amusement park
Full name of responsible person
Zeynab Firozeh
Street address
32meter Shohada
City
bojnourd
Province
North Khorasan
Postal code
9417618875
Phone
+98 58 3228 7930
Email
zfirozeh@yahoo.com
2
Recruitment center
Name of recruitment center
afarinesh park
Full name of responsible person
zeynab firozeh
Street address
Dolat Sq.
City
bojnourd
Province
North Khorasan
Postal code
9417618875
Phone
+98 58 3228 7930
Email
zfirozeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Dr. Ahmed Farzaneh kord
Street address
Postbox 397, Hakim Sabzavari University, Tohidshahr, Sabzevar, Khorasan Razavi
City
sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2520
Email
afarzaneh@hsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hakim Sabzevari University
Proportion provided by this source
20
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
2
Sponsor
Name of organization / entity
Hakim sabzevari university
Full name of responsible person
Zeynab firozeh
Street address
No 10, Qiam 1st, Bojnourd
City
Bojnourd
Province
North Khorasan
Postal code
941618875
Phone
+98 58 3228 7930
Email
zfirozeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
Proportion provided by this source
80
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Hakim sabzevari university
Full name of responsible person
Zeynab Firozeh
Position
PHD student of exercise physiology
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Tohid shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 0104
Email
zfirozeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of Hakim Sabzevari
Full name of responsible person
Zeynab firozeh
Position
The Student of PHD
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Tawhid settlement
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 0104
Email
zfirozeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hakim sabzevari university
Full name of responsible person
Zeynab Firozeh
Position
PHD student of exercise physiology
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Tohid shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 0104
Email
zfirozeh@yahoo.com
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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is shared after being unidentified
When the data will become available and for how long
One year after the publication of the results
To whom data/document is available
All people who need this data
Under which criteria data/document could be used
Lake of Plagiarism
From where data/document is obtainable
Saeid Ramezani
rsaeid92@gmail.com
What processes are involved for a request to access data/document
A week after sending a request to Gmail and an applicant's commitment to not use the data directly
Comments
The main concern of each researcher is the misuse of others by his research information.
If this item is assured, all research information will be available.