Comparison of three training interventions (aerobic interval, resistance and combination) on serum FAM19A5, arterial stiffness, glucose homeostasis and lipid and body composition indices in obese men
Comparison of three training interventions (aerobic interval, resistance and combination) on serum FAM19A5, arterial stiffness, glucose homeostasis and lipid and body composition indices in obese men
Design
A randomized clinical trial with a control group, parallel groups, 100 patients. Randomization is performed simply and individually, and patients are grouped in groups 1, 2, 3, and 4, respectively.
Settings and conduct
Research subjects will participate in four groups for 12 weeks (three days a week). All measurements and exercises will be measured in Sabzevar.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Body mass index 30 to 35, Age 40 to 50 years. Exclusion criteria: having cardiovascular diseases, liver disease, kidney disease and having regular physical activity in at least the last six months
Intervention groups
Experimental groups: aerobic- interval, resistance, combined training groups will practice for 12 weeks (three sessions per week). The control group will be community based and without exercise.
Main outcome variables
FAM19A5، Arterial stiffness, Glucose, Insulin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151026024717N4
Registration date:2022-01-10, 1400/10/20
Registration timing:prospective
Last update:2022-01-10, 1400/10/20
Update count:0
Registration date
2022-01-10, 1400/10/20
Registrant information
Name
Ehsan Mir
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 17 3544 0186
Email address
ehsanmir@stu.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-09, 1400/11/20
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three training interventions (aerobic interval, resistance and combination) on serum FAM19A5, arterial stiffness, glucose homeostasis and lipid and body composition indices in obese men
Public title
Comparison of three training interventions in obese men
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of the health of the subjects,
Body mass index between 30 and 35,
Age 40 to 50 years
Exclusion criteria:
having cardiovascular diseases,
musculoskeletal disorders,
liver diseases,
kidney diseases,
thyroid dysfunction,
having regular physical activity in at least the last six months
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, subjects are selected simple randomization by random allocation rule. After determining the sample size, they will be equally divided into four groups (1- control, 2- aerobic interval training, 3- resistance training, 4- combined training).
Using the lottery method, the names of the subjects are written on separate papers and placed in a container, then the names of the subjects are randomly taken out and placed in 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
Baqiyatallah Al-Azam Educational and Medical Center
Before the intervention and 48 hours after the end of intervention
Method of measurement
ELISA method
2
Description
Arterial stiffness
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
Through the pulse pressure formula
3
Description
lipid indices
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
ELISA method
4
Description
Body composition
Timepoint
Before the intervention and 48 hours after the end of intervention
Method of measurement
Body Composition Analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aerobic interval training program including 10 minutes of warm-up with 40% of maximum heart rate (HRmax) and 40 minutes of cycling including eight cycles, each of which is 3 minutes with 80% of maximum heart rate (high intensity) and 2 minutes It will run at 50% of maximum heart rate (low intensity cycle) and 10 minutes of cooling with 40% of maximum heart rate.
Category
Prevention
2
Description
Intervention group: The resistance training program will include squats, chest presses, front thighs, back thighs, overhead wires, boat wires, forearms and back arms. During the first week, subjects perform 2 sets of 12-15 repetitions with an intensity of 40% 1RM. In the second week, the program includes 3 sets of 15-12 repetitions with an intensity of 50% 1RM. Between 3-5 weeks with the same number of sets, the number of repetitions will decrease to 8-12 and the intensity will increase to 55-60% of 1RM. From the sixth to the twelfth week, the number of repetitions of 8-12 is maintained. On the other hand, the intensity of training will increase to 80-65% of 1RM.
Category
Prevention
3
Description
Intervention group: The combined training program is such that the subjects of this group perform one session of aerobic periodic training (according to the program of aerobic periodic group), and the next session performs resistance training (according to the program of the resistance group) and This process will continue until the end of the 12-week program for this group.
Category
Prevention
4
Description
Control group: community-based and untrained.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Center of Applied Science and Technology 2
Full name of responsible person
Arash Mohammadi
Street address
No. 137, Northern Side of the Mother square
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613698516
Phone
+98 51 4422 6110
Email
sabzevar2uast@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Behzad Bazgir
Street address
Baqiyatallah University of Medical Sciences, MollaSadra street , Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
Ehanmir1990@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Behzad Bazgir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Baqiyatallah University of Medical Sciences, MollaSadra street , Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3131
Email
Ehsanmir1990@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Behzad Bazgir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Baqiyatallah University of Medical Sciences, MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3131
Email
Ehsanmir1990@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Behzad Bazgir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Baqiyatallah University of Medical Sciences, MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
Ehsanmir1990@gmail.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
Yes - There is a plan to make this available
Title and more details about the data/document
The whole data is potentially shared after unidentified individuals.
When the data will become available and for how long
The beginning of the data access period is 6 months after the publication of the articles.
To whom data/document is available
The data will be accessible only to researchers working in academic institutions.
Under which criteria data/document could be used
The data will be available as generally and non publication by the recipient.
From where data/document is obtainable
To receive research information, send an email to Ehsanmir1990@gmail.com
What processes are involved for a request to access data/document
Data will be sent after obtaining permission from the project manager.