The effects of eight weeks aerobic, resistance, and combined exercises on plasma Irisin levels, insulin resistance and lipid profiles among obese women with metabolic syndrome
Compare effects of eight weeks aerobic, resistance, and combined exercises on plasma Irisin levels, insulin resistance and lipid profiles among obese women with metabolic syndrome
Design
Clinical trials with control group, with parallel groups, randomized
Settings and conduct
This study was conducted from February 2016 on 60 obese women with MetS. The study population comprised of women with metabolic syndrome (using simple random sampling) who were visiting public clinic (Emam Reza Clinic) running by Shiraz University of Medical Sciences. Literate participants read and signed informed consent, and verbal consent was obtained from illiterate patients.
Participants/Inclusion and exclusion criteria
60 Female Metabolic Syndrome/ Having at least 3 components of metabolic syndrome,Women 45-60 years old,No history of any specific disease (cancer, diabetes, cardiovascular problems, Skeletal-muscular / diagnosed with any history of any specific disease (cancer, diabetes, cardiovascular problems, Skeletal-muscular
Intervention groups
1- Aerobic training group 2- Resistance training group 3- Combined training group (aerobic-resistance) 4- Control group
The effects of eight weeks aerobic, resistance, and combined exercises on plasma Irisin levels, insulin resistance and lipid profiles among obese women with metabolic syndrome
Public title
The effects of eight weeks aerobic, resistance, and combined exercises on plasma Irisin levels, insulin resistance and lipid profiles among obese women with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 3 components of metabolic syndrome
Women 45-60 years old
No history of any specific disease (cancer, diabetes, cardiovascular problems, Skeletal-muscular problems)
Exclusion criteria:
diagnosed with history of any specific disease (cancer, diabetes, cardiovascular problems, Skeletal-muscular problems)
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
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
Shiraz University of Medical Sciences Ethics Committee
Street address
Eram Street
City
Shiraz
Province
Fars
Postal code
159/535121
Approval date
2018-07-02, 1397/04/11
Ethics committee reference number
IR.SHUMS.REC.1397.279
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
2
Description of health condition studied
Diabets
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Irisin
Timepoint
measurement at the beginning of the study (before the intervention) and 2 months after the intervention
Method of measurement
Measurement Plasma Irisin Level Using Elis Kit Made in Germany.
Secondary outcomes
1
Description
Glocose
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention began
Method of measurement
fasting blood glucose (glucose oxidase) measured
2
Description
Insulin
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention began
Method of measurement
The level of insulin was measured by ELISA
3
Description
Triglyceride
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention began
Method of measurement
triglyceride (PAP-GPO / lipase) measured
Intervention groups
1
Description
Intervention group first: Aerobic training group En. Participants of this group performed their activities using treadmill or bicycle three times per week (on non consecutive days). Time of exercise was increased from 20 minutes per session (at 60% of maximum heart rate) to 60 minutes (at 75% of maximum heart rate) per session. Heart rate was regularly determined by the monitor’s treadmill or cycle ergometers. Required heart rate was calculated by the Karvonen formula
Category
Treatment - Devices
2
Description
Intervention group second: Resistance training group En. Resistance training group This program was performed on different weight machines. Correct training techniques were instructed and supervised by professional trainers. The protocol was started on 2 days of the week during the first month and was increased to 3 non-consecutive days per week. Training was started during weeks 1 and 2 with intensity 60% onerepetition maximum (1RM) and was progressed to intensity 75-80% 1RM. The number of sets was 1-2 during the first month. This program included 10 different exercises for upper and lower body. Participants performed 3 sets of 8-10 repetitions (with a 90- 120 s rest between sets) of the following exercises: bench press, seated row, shoulder press, chest press, lateral pulldown, abdominal crunches, leg press, leg extension, triceps pushdown and seated bicep curls
Category
Treatment - Devices
3
Description
Intervention group third: Combined training group (aerobic-resistance) En. Combined training group (aerobic-resistance) The subjects of this group did the aerobic exercise plus resistance training programs 3 times a week. After a warm-up stage, they worked for 20-30 minutes on a treadmill or bicycle plus 2 sets of each of 8 exercises with 8-10 repetitions on weight machines
Category
Treatment - Devices
4
Description
control group: control group .En control group: control group A group that did not have any training intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Clinic affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Dianatinasab Mostafa
Street address
Motahhari Street
City
Shiraz
Province
Fars
Postal code
159-535121
Phone
+98 71 5388 1200
Email
dianatinasab@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dianatinasab Mostafa
Street address
Motahhri Street
City
Shiraz
Province
Fars
Postal code
591-535121
Phone
+98 71 5383 1200
Email
dianatinasab@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dianatinasab Mostafa
Position
Epidemiologist
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Motahhari Street
City
Shiraz
Province
Fars
Postal code
591-535121
Phone
+98 71 5383 4701
Email
dianatinasab@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dianatinasab Mostafa
Position
Epidemiologist
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Motahhari Street
City
Shiraz
Province
Fars
Postal code
591-535121
Phone
+98 71 5383 4701
Email
dianatinasab@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dianatinasab Mostafa
Position
Epidemiologist
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Motahhari Street
City
Shiraz
Province
Fars
Postal code
591-535121
Phone
+98 71 5383 4701
Email
dianatinasab@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Disagreement with contractors to share their profile and data
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Only scholars working in academic institutions
Under which criteria data/document could be used
Only numerical analysis is allowed.
From where data/document is obtainable
Mostafa Dianti Install with Email Address: dianatinasab@sums.ac.ir
What processes are involved for a request to access data/document