Determining the effect of eight weeks of combined training on sirtuin 1 levels in men with metabolic syndrome
Determining the effect of eight weeks of combined training on microRNA-122 in men with metabolic syndrome
Determining the effect of eight weeks of combined training on FBS in men with metabolic syndrome
Determining the effect of eight weeks of combined training on glycosylated hemoglobin in men with metabolic syndrome
Determining the effect of eight weeks of combined training on the lipid profile of men with metabolic syndrome
Design
A clinical trial with the control group, with parallel, randomized groups, on 30 patients.Randomization by the method of equal blocks (8 blocks of 4) in which in each block half of the intervention and half of the people are considered as a comparison
Settings and conduct
Patients with metabolic syndrome in Imam Hossein (AS) Malayer Hospital
Participants/Inclusion and exclusion criteria
30 men aged 45-65 years (selected. These people had high blood pressure (more than 90/140 mm Hg), triglyceride levels above 150 mg / dL, fasting blood sugar above 120 mg/dl, and Obesity was also central. Then individuals were randomly divided into two groups of 15 combined exercise and control.
Intervention groups
Combined exercise group: which undergoes training intervention.
Main outcome variables
Combined training on sirtuin 1 and microRNA-122 levels in men with metabolic syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170114031921N1
Registration date:2022-05-30, 1401/03/09
Registration timing:prospective
Last update:2022-05-30, 1401/03/09
Update count:0
Registration date
2022-05-30, 1401/03/09
Registrant information
Name
homa naderifar
Name of organization / entity
Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 6134
Email address
homa.naderifar@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-06, 1401/03/16
Expected recruitment end date
2022-12-07, 1401/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks combined training on the level of sirtuin1 and MicroRNA-122 in men with metabolic syndrome
Public title
The effect of combination exercises on metabolic syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Men with metabolic syndrome
Age range between 45-65 years
Exclusion criteria:
Inability and inability to perform physical activity
Age
From 45 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is commonly used to balance the number of samples assigned to each of the intervention and comparison groups. This feature makes the number of samples assigned to each of the study groups equal in cases where intermediate analyzes are needed during the sampling process. In this randomization, the method of equal blocks (8 blocks of 4) is used in which in each block, half of the intervention subjects and half are considered as comparisons. And we assigned it to different groups. How and tool to generate random block sequences using the site https://www.sealedenvelope.com/simple-randomiser/v1/lists done.
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
Ethics committee of University of Medical Scieneces
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2022-05-07, 1401/02/17
Ethics committee reference number
IR.UMSHA.REC.1401.145
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
Primary outcomes
1
Description
Percentage of people who have decreased MicroRNA-122 levels
Timepoint
MicroRNA-122 measurement before and after the intervention
Method of measurement
Dedicated kit
2
Description
Percentage of people whose sirtuin levels have increased
Timepoint
measurement before and after the intervention
Method of measurement
Dedicated kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: training intervention. In the combined training group (resistance-aerobic) an 8-week aerobic program will include three training sessions per week and about one hour per day, which includes running on a treadmill. In this exercise program, subjects with 55% of maximum heart rate for 25 minutes (first 2 weeks), 55 to 65% of maximum heart rate for 35 minutes (second 2 weeks), 65 to 75% of maximum heart rate for 40 minutes Last 4 weeks) practiced. Before starting the exercise, the subjects warmed up for 10 minutes with soft and stretching movements, and at the end of the exercise, they cooled themselves for 10 minutes with stretching movements. Also, the maximum heart rate was obtained through the age-220 formula. Comes and intensity of exercise was adjusted according to the desired percentage of maximum heart rate (Wilmore and Castiel, 1994). Resistance training with bodybuilding machines for 8 weeks and three sessions per week include: horizontal exercises, forearms, leg presses and Swedish swimming.
Category
Rehabilitation
2
Description
Control group: Which is not included in any training program
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein (AS) Hospital
Full name of responsible person
Saeid Shamloo Kazemi
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0063
Email
hnaderifar121@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohi
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
hnaderifar121@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Homa Naderifar
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
0098813838063
Email
hnaderifar121@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Homa Naderifar
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
0098813838063
Email
hnaderifar121@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Homa Naderifar
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
0098813838063
Email
hnaderifar121@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be sent to the researcher if the intellectual property rights are protected
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
Submit a written application and complete the intellectual property form (one week)