Overall Objective: The effect of eight weeks of intense and continuous periodic exercises on plasma levels of myeloperoxidase in diabetic type 2
Design
30 Type 2 diabetic patients with a randomized configuration will be divided into three groups of control, periodic exercises and continuous training. How to randomize through the numbers table.
Settings and conduct
This research will be carried out in the rehabilitation department of Tehran's Shahid Rajaee Heart Hospital. Except for the researcher, none of the participants will be informed about how to assign individuals in different groups.
Participants/Inclusion and exclusion criteria
Type 2 diabetic patients aged 35 to 60 years with a BMI of 25 to 35 kilogarm/ m 2 will be included in this study. Individuals with cardiovascular disease, kidney and kidney problems, pulmonary disease , Cancer, gout, or orthopedic constraints will be eliminated. Also, subjects should not take any sporting activity two or three months before the protocol commences.
Intervention groups
Control group (n = 10), severe periodic exercise group (n = 10), continuous training group (n = 10).
Main outcome variables
In general, the purpose of this exercise is to reduce the inflammatory factor of myeloproxidase in type 2 diabetic patients and to slow down the progression of the disease and the complications of the disease.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181219042055N1
Registration date:2019-02-17, 1397/11/28
Registration timing:retrospective
Last update:2019-02-17, 1397/11/28
Update count:0
Registration date
2019-02-17, 1397/11/28
Registrant information
Name
Sara Lotfian
Name of organization / entity
Shaheed Rajaee Heart Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2489
Email address
lotfiyan.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-28, 1397/10/07
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of eight weeks of intense and continuous periodic exercises on plasma levels of myeloperoxidase in type 2 diabetic patients
Public title
The effect of two types of aerobic exercise on inflammatory factors in diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People with type 2 diabetes
Age range 35 to 60 years
Body mass is between 25 and 35 kg / m 2
Exclusion criteria:
People with cardiovascular disease
People with pulmonary disease
People with pulmonary disease
smokers
Alcoholic people
People who have gout or orthopedic restrictions
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Tool: Randomization Tool: Like a random number table, a stacked envelope, a statistical software of the lottery method was used after the sample size was determined. For each member of the community, we assigned a code or number, and it was written on cardboard and poured into a bag, and then one out of the bag.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is done in trivial blinds and the only researcher knows how to assign individuals to different groups. In general, all participants in this project are unaware of what kind of sports group they have been told, and the researcher will individually give the exercises to individuals, and no explanation will be given about the type and name of the exercise. The only workout style that is aerobic and will be done on the treadmill will be notified to individuals. In data analyzers, clinical care, outcome evaluators, as well as safety committees and data monitoring, there will be no information about how to assign exercises.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Educational Center, Shahid Rajaee Cardiology Research Research Center
Street address
Valiasr Ave., Intersection of the prayer center of Shahid Rajaee Cardiology Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2018-09-29, 1397/07/07
Ethics committee reference number
IR.RHC.REC.1397.048
Health conditions studied
1
Description of health condition studied
Type 2 diabetes patients
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
plasma levels of Myeloperoxidase
Timepoint
Before starting the training protocols and 8 weeks later (after completing the practice protocols)
Method of measurement
blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: An intense periodic exercise group that performs aerobic training for 8 weeks and 3 sessions per week.
Category
Prevention
2
Description
Intervention group: The continuous training group will conduct aerobic training sessions for 8 weeks and 3 sessions per week.
Category
Diagnosis
3
Description
The control group is not given any training
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
sara lotfiyan
Street address
Valiasr St., Intersection of Prayer, Research Center for Heart and Shahid Rajaee Heart Therapy
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2489
Email
lotfiyan.s@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Treatment Center for Sshahid Rajaee Heart and Heart Research Center
Full name of responsible person
sara lotfiyan
Street address
Valiasr Street, next to Mellat Park - Nabash Nayesh, Shahid Rajaee Heart and Heart Research and Treatment Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2489
Email
lotfiyan.s@iums.ac.ir
Grant name
The author of the project, Dr. Mohsen Adandi, is from Semnan University and some of the funding for this project will be from their Grant.
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan University
Proportion provided by this source
100
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
Academic
2
Sponsor
Name of organization / entity
Shahid Rajaee Cardiology Research and Treatment Center
Full name of responsible person
Dr. Majid Maleki
Street address
Valiasr Street, next to Mellat Park - Nabash Nayesh, Shahid Rajaee Heart and Heart Research and Treatment Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
nahidmahdieh95@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaee Cardiology Research and Treatment Center
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
Research center for cardiovascular and cardiology research of Shahid Rajaee
Full name of responsible person
sara lotfiyan
Position
Faculty member
Latest degree
Specialist
Other areas of specialty/work
Sports medicine
Street address
Valiasr St., Intersection of Prayer, Research Center for Heart and Shahid Rajaee Heart Therapy
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 23922489
Email
lotfiyan.s@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Sohsen Avandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Semnan - Opposite Sokan Park - Campus No. 1 - Central Organization of Semnan University
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3365 4100
Fax
+98 23 3332 1005
Email
mohsenavandi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Mohsen Avandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Central organization of Semnan University,in front 0f the S0kan Park,
City
Semnan
Province
Tehran
Postal code
35131-19111
Phone
+98 41336523
Fax
+98 23 3332 1005
Email
mohsenavandi@gmail.com
Web page address
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
In this study, the personal information of the participants in the project, such as age range, height range, weight range, BMI range, individuals will be published as a table.Also, after completing the protocol, the result of the effect of different protocols. It will also be noted on specified factors as well as factors such as insulin resistance and HA1C willalso be published.
When the data will become available and for how long
Access time since 1398
To whom data/document is available
All participants in this project can get results if they so wish. Also, all diabetics at the Shahid Rajaee Cardiology and Semnan University can access the results of this project. People working in the rehabilitation departments of Rajaee Hospital.
Under which criteria data/document could be used
Participants in the study and diabetics at Shahid Rajaee Hospital, and in order to know how the protocols affect the conditions of their illness, they can be informed of the results and documentation so that they can be used if the protocols are useful. Also, researchers can access the documentation to use the results in similar research. People working in rehab groups can also use documentation and protocols to conduct protocols for diabetics.
From where data/document is obtainable
Individuals can send their requests to the following email addresses:mohsenavandi@gmail.com
What processes are involved for a request to access data/document
Individuals requesting an email with an incident request will send their addresses to them. Upon receipt of the email, a form will be sent to them, specifying the individuals and the reason they will be required to register on this form after completing the form and resubmitting. The form will be submitted to the pdf file by email.