Protocol summary

Summary
Purpose: Comparison the effect of circuit resistance training and jogging exercise training on the metabolic syndrome of females with diabetes type II. Thirty women with type II diabetes and body mass index 29.90±3.98 kg/m2 were randomly divide to circuit resistance training; jogging training and control group. Circuit resistance training is consist of 8 station with 40- 65% 1RM and also leg extensions, lying leg curl; bench press; Cable triceps push down; front arm, leg press; Cable Row and Sit-ups. Jogging training is include; 25-50 min with 45-75% of maximum heart rate. Inclusion criteria are: Lack of training exercises in the past year ; Maximum age 60 years; Fast blood glucose more than of 126 mg/d. exclusion criteria: Patients with Acute cardiovascular disease and Joint and bone diseases. Before and after 12 weak exercise; body composition; blood samples and Blood pressure will be estimated .Body composition is consist of: weight; waist circumference; height; blood glucose . blood samples is consist of: fasting blood glucose; HbA1c and blood lipid indexes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015111122498N3
Registration date: 2016-02-06, 1394/11/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-06, 1394/11/17
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Rasht Branch, Islamic Azad University
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of circuit resistance training and jogging exercise training on of metabolic syndrome of females with diabetes type II
Public title
Effect of circuit resistance training and jogging training in diabetes type II
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are: Lack of exercise training in one year ago; Maximum age of 60 years; Fast blood glucose more than 126 mg/d. exclusion criteria are: Patients with Acute cardiovascular disease and Joint and bone diseases.
Age
From 40 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
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
Ethics Committee, Islamic Azad University
Street address
Lakan gate, Azad University, Rasht Branch, Rasht
City
Rasht
Postal code
Approval date
2013-02-07, 1391/11/19
Ethics committee reference number
11721404912003

Health conditions studied

1

Description of health condition studied
diabetes type II
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Fast blood sugare
Timepoint
Before intervention and Three months after intervention
Method of measurement
According to milligrams per deciliter and by Baseline blood

2

Description
Waist circumference
Timepoint
Before intervention and Three months after intervention
Method of measurement
According to cm and by Tape measure

3

Description
Triglyceride
Timepoint
Before intervention and Three months after intervention
Method of measurement
According to milligrams per deciliter and by Baseline blood

4

Description
High-density lipoprotein
Timepoint
Before intervention and Three months after intervention
Method of measurement
According to milligrams per deciliter and by Baseline blood

5

Description
Systolic Blood pressure
Timepoint
Before intervention and Three months after intervention
Method of measurement
According to mm Hg and by Mercury Barometer

6

Description
Diastolic blood pressure
Timepoint
Before intervention and Three months after intervention
Method of measurement
According to mmHg and by Mercury Barometer

Secondary outcomes

1

Description
Body mass index
Timepoint
Before intervention and Three months after intervention
Method of measurement
According to Kg/m2 and dividing body weight by the square of the height(m2)

2

Description
Glycated Haemoglobin
Timepoint
Before intervention and Three months after intervention
Method of measurement
According to percent and by Baseline blood

3

Description
Total cholstrol
Timepoint
Before intervention and Three months after intervention
Method of measurement
According to percent and by Milligrams per deciliter

4

Description
Low-density lipoprotein
Timepoint
Before intervention and Three months after intervention
Method of measurement
According to Milligrams per deciliter and by Baseline blood

5

Description
Weight
Timepoint
Before intervention and Three months after intervention
Method of measurement
According to kilograms and by balance

Intervention groups

1

Description
This training was with intensity of 60-75% maximum heart rate and duration 25-50 min.This training composed of walking and jogging for 3 days/week.
Category
Lifestyle

2

Description
Circuit resistance training: The Circuit resistance training consisted of leg extensions, lying leg curl, bench press, Cable triceps push down front arm, leg press , Cable Row and Sit-ups with 40-65 % 1RM.This training was to form of circuit with eight station and initiated 3 days/week for 3 month.
Category
Lifestyle

3

Description
No action
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ansari Hospital of Roudsar
Full name of responsible person
Maryam Sazgari
Street address
Enghelab Street, Shahrdari square, Diabetes Unit in Ansari Hospital of Roudsar,Roudsar, Guilan
City
Rodsar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, University of Islamic Azad, Rasht Branch
Full name of responsible person
Dr.Ramin Shabani
Street address
Lakan gate, Azad University, Rasht Branch, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of Islamic Azad, Rasht Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University, Rasht Branch
Full name of responsible person
Marzieh Nazari
Position
MA
Other areas of specialty/work
Street address
Lakan gate, Azad University, Rasht Branch, Rasht, Guilan
City
Rasht
Postal code
4147654919
Phone
+98 13 3342 3308
Fax
Email
m_nazari1390@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Rasht Branch
Full name of responsible person
Dr.Ramin Shabani
Position
PhD
Other areas of specialty/work
Street address
Lakan Gate, Islamic Azad University, Rasht Branch, Rasht
City
Rasht
Postal code
4147654919
Phone
+98 13 3342 3308
Fax
Email
shabani@iaurasht.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad Universit, Rasht Branch
Full name of responsible person
Marzieh Nazari
Position
MA
Other areas of specialty/work
Street address
Lakan gate,Islamic Azad University, Rasht Branch, Guilan
City
Rasht
Postal code
4147654919
Phone
+98 13 3342 3308
Fax
Email
m_nazari1390@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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