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The Effect of 12-Week Cyclic Yoga on some Blood Factors, Anthropometric and Upper Body Abnormalities of Type 2 Diabetic Middle-Aged Women

Protocol summary

Study aim
Investigating the Effect of 12 Weeks of Cyclic Yoga Exercise on Blood Indices, Anthropometric Indices and Upper Limb Abnormalities in Middle-Aged Women with Type 2 Diabetes
Design
In this clinical trial with a control group, 46 patients who met the conditions to enter the study were randomly divided into two groups based on lottery.
Settings and conduct
The research method will be quasi-experimental with two yoga exercise group and control groups with pretest and post test. Subjects are 46 Middle-aged type 2 diabetic women in Kermanshah city. Blood variables will be measured in the mother clinic laboratory. Yoga exercise and Abnormalities and anthropometric measurements will be measured in Rize Vandi gym.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 diabetic women 40 to 60 years old with overweight, With forward shoulder, hyperkiphosis, hyperlordosis abnormalities Exclusion criteria: Insulin treatment, Complications of diabetes (neuropathy, nephropathy, retinopathy), Hormone therapy, Smoking, drugs and alcohol, History of fractures, surgery or joint diseases, Any pain and swelling in the measured positions, History of cardiovascular and mental illness
Intervention groups
Intervention group: Yoga exercise group: This group performed cyclic yoga exercise for two months, three days a week. Cyclic Yoga is the art of sequencing yoga asana, pranayama and mudra techniques to maximize their benefits and energize the mind and body. Control group: They did not have regular physical activities during the intervention.
Main outcome variables
Glycosylated hemoglobin, fasting blood glucose, cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, waist circumference, hip circumference, blood pressure, insulin hormone, body fat percentage, body mass index, forward shoulder abnormality, kyphosis abnormality, lordosis abnormality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110527006611N5
Registration date: 2023-11-12, 1402/08/21
Registration timing: retrospective

Last update: 2023-11-12, 1402/08/21
Update count: 0
Registration date
2023-11-12, 1402/08/21
Registrant information
Name
Zahra Bayat
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 83 3822 9422
Email address
zahra_bayat2008@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
2021-02-03, 1399/11/15
Actual recruitment end date
2022-02-19, 1400/11/30
Trial completion date
2022-02-19, 1400/11/30
Scientific title
The Effect of 12-Week Cyclic Yoga on some Blood Factors, Anthropometric and Upper Body Abnormalities of Type 2 Diabetic Middle-Aged Women
Public title
The Effect of Yoga Exercise on Type 2 Diabetic Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic women 40 to 60 years old with overweight With forward shoulder, hyperkiphosis, hyperlordosis abnormalities
Exclusion criteria:
Insulin treatment Complications of diabetes (neuropathy, nephropathy, retinopathy) Hormone therapy Smoking, drugs and alcohol, Participating in exercise activities during the last 6 months Any pain and swelling in the measured positions History of cardiovascular and mental illness History of fractures, surgery or joint diseases,
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Actual sample size reached: 42
Randomization (investigator's opinion)
Randomized
Randomization description
After reviewing the patients' records at Taleghani Hospital Diabetes Center, 46 patients who met the inclusion and exclusion criteria of the study were selected. They were given a number from 1 to 46. Then the number of each of them was written on a small paper and poured into a container. One of the hospital staff was asked to take the papers out of the container. The researcher wrote the names in the control and yoga exercise 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
Research Ethics Committees of Kermanshah University of Medical Sciences
Street address
(AS) Building No. 2, In front of Imam Ali Hospital, Shahid Beheshti blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2021-08-03, 1400/05/12
Ethics committee reference number
IR.KUMS.REC.1400.466

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Hyperkyphosis
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Flexible Ruler

2

Description
Hyperlordosis
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Flexible Ruler

3

Description
Shoulder forward
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Double Square device

Secondary outcomes

1

Description
Glycosylated Hemoglobin
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Blood test with Biorexfars kit

2

Description
HDL Cholesterol
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Blood test with BioSystems kit

3

Description
LDL Cholesterol
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Blood test with BioSystems kit

4

Description
Triglycerides
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Blood test with BioSystems kit

5

Description
Cholesterol
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Blood test with BioSystems kit

6

Description
Waist Circumference
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Standard tape meter

7

Description
Hip Circumference
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Standard tape meter

8

Description
Fasting Blood Glucose
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Blood test with BioSystems kit

9

Description
Blood Pressure
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
brachial digital blood pressure monitor

10

Description
Insulin Hormone
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Blood test with Siemens kit made in America

11

Description
Body Mass Index
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Mark Tanita Body Composition Test Device

12

Description
Body fat percentage
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Mark Tanita Body Composition Test Device

Intervention groups

1

Description
Intervention group: Yoga exercise group: This group performed cyclic yoga exercise for three months, three days a week. Cyclic Yoga is the art of sequencing yoga asana, pranayama and mudra techniques to maximize their benefits and energize the mind and body.The program of selected cyclic yoga exercises includes stretching exercises for large and small pectoral muscles, internal rotators of the arm, glutes, hamstrings, and strengthening the trapezius and rhomboid muscles and the external rotators of the arm and the central muscles of the body were performed in the style of cyclic yoga.Each training session lasted about 50 to 90 minutes. The duration of the exercises increased gradually. Before the start of the test, the patients were taking one tablet of metformin daily. The dosage of the patients' medicine did not change
Category
Lifestyle

2

Description
Control group: During the intervention, they did not have regular physicsl activities. Before the start of the test, the patients were taking one tablet of metformin daily. The dosage of the patients' medicine did not change
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Research Center
Full name of responsible person
Mehrali Rahimi
Street address
Diabetes Research Center, Next to Taleghani Hospital, Beheshti Blvd, Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
67158 47167
Phone
+98 918 132 4023
Email
ma_rahimi@kums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus Jalili
Street address
No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti Street, Kermanshah city
City
kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3837 6967
Fax
+98 83 3838 4185
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Payame Noor University of Tehran (South)
Full name of responsible person
Seyedeh Soolmaz Mahdioun
Position
Exercise Coach
Latest degree
Master
Other areas of specialty/work
Corrective Exercises
Street address
Mersad Gym, Sangar Crossroad, 22 Bahman, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714666647
Phone
+98 83 3838 3184
Email
soolmazmahdioun@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehrali Rahimi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Kermanshah University of Medical Sciences, In front of Imam Ali Hospital, Shahid Beheshti Blvd, Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 918 132 4023
Email
ma_rahimi@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Zahra Bayat
Position
PhD of University of Tehran
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Biochemistry and Metabolism
Street address
Kish International Campus, University of Tehran, Niyayesh St., Mirmohanna Blvd., Kish Island, Iran.
City
Kish Island
Province
Hormozgan
Postal code
79416-55665
Phone
+98 918 617 1231
Email
z.bayat@ut.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data received from participants will remain confidential but general results will be published without individual identification.
When the data will become available and for how long
8 months after the completion of the research
To whom data/document is available
For university students and students in research related fields
Under which criteria data/document could be used
There are no specific conditions to provide such information
From where data/document is obtainable
Zahra Bayat Email: z.bayat@ut.ac.ir
What processes are involved for a request to access data/document
Send message to the person responsible for providing the data Email: z.bayat@ut.ac.ir
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