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The effect of yoga exercise with dumbbells along with spirulina supplement on liver enzymes of elderly Bushehr women

Protocol summary

Study aim
The general purpose of this research is to investigate the effect of 8 weeks of yoga practice with weights along with spirulina supplement on liver enzymes in elderly women.
Design
In short, volunteers are randomly divided into 4 groups according to body mass index. Therefore, the trial will be conducted for 8 weeks, and the variables should be measured before the start and again after the completion of the study.
Settings and conduct
The study is carried out in collaboration with the University of Medical Sciences in the sports hall of this university. Therefore, this study is designed for 8 weeks, of course, in the first month, there will be two sessions per week, and then in the second month, three sessions per week, each session lasting approximately one hour.
Participants/Inclusion and exclusion criteria
Absence of autoimmune diseases and diabetes They were suffering from infectious diseases, chronic liver diseases and inflammatory diseases
Intervention groups
In the intervention groups and even the control group, people are examined for the effectiveness of the exercise and supplement protocol, and in groups one and two, we will have spirulina supplements three times a day before meals. Also, the exercise protocol, which is yoga with weights, starts with weights of 450 grams to gradually increase the volume and load of the exercises.
Main outcome variables
In this study, liver enzymes, which were dependent factors, and the effect of weight-bearing yoga exercise and spirulina supplement consumption on these variables were investigated.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230527058308N1
Registration date: 2023-07-01, 1402/04/10
Registration timing: registered_while_recruiting

Last update: 2023-07-01, 1402/04/10
Update count: 0
Registration date
2023-07-01, 1402/04/10
Registrant information
Name
Mohadeseh Bandarrigi
Name of organization / entity
The university of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 77 3344 7040
Email address
m-bandarrigi@stu.scu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-15, 1402/03/25
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yoga exercise with dumbbells along with spirulina supplement on liver enzymes of elderly Bushehr women
Public title
"Investigating the effect of spirulina on liver enzymes" "The effect of yoga with weight on liver enzymes"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Not suffering from autoimmune diseases Not suffering from thyroid problems and diabetes Elderly women over 60 years old Not having allergies or sensitivities to seafood Resident of Bushehr city
Exclusion criteria:
Age
From 60 years old to 68 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
After filling out the consent forms and medical records, they were randomly divided into 4 groups based on body mass index and age.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Gradually increasing the time of training sessions in order to increase the training load and not to perform other sports activities at the same time during the study period.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Shahid Chamran University
Street address
Sadat 7 Alley, Estakhr Ave, Sabzabad street, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7516794754
Approval date
2023-02-14, 1401/11/25
Ethics committee reference number
EE/1401.2.24.173094/scu.ac.ir

Health conditions studied

1

Description of health condition studied
To identify and prevent liver problems or diseases affecting liver enzymes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
ََAspartate aminotransferase (AST) enzymes
Timepoint
Measurement of blood cholesterol at the beginning of the study (before the start of the intervention) and after the end of the study (60 days)
Method of measurement
blood draw

2

Description
Alanine aminotransferase (ALT)
Timepoint
Measurement at the beginning of the study (before the start of the intervention) and after the end of the study (60 days)
Method of measurement
blood draw

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: participating in yoga sessions with weights and received a spirulina supplement. (500g spirulina capsules three times a day before each meal for 8 weeks)
Category
N/A

2

Description
The second intervention group: only participating in yoga sessions with weights without receiving supplements. (Actually, they received Nama supplement or placebo in the form of 500 gram capsules with starch to consume 3 times a day)
Category
N/A

3

Description
The third intervention group: this group only received supplements. (500g spirulina capsules three times a day before each meal for 8 weeks)
Category
N/A

4

Description
Control group: This group also did not participate in any exercise sessions and supplement consumption.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Medical Complex - Mehr Pathobiology Laboratory
Full name of responsible person
Dr. Mohammad Reza Farzaneh
Street address
Shafa Medical Complex, Tawheed Branch, in front of Sepeh Bank, Sangi Street, Bushehr
City
Bushehr
Province
Boushehr
Postal code
6135783151
Phone
+98 77 3353 1383
Fax
Email
Oisc@scu.ac.ir
Web page address
https://scu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Dr. Saeed Shakarian
Street address
Shahid Chamran University of Ahvaz, , Golestan Boulevard, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
+98 61 3322 6614
Email
Oisc@scu.ac.ir
Web page address
https://scu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Chamran University of Ahvaz
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
The university of Ahvaz
Full name of responsible person
Mohadeseh Bandarrigi
Position
Coach and teacher
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Sadat 7 Alley, Estakhr Ave, Sabzabad street, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7516794754
Phone
+98 77 3344 7040
Fax
Email
m-bandarrigi@stu.scu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The university of Ahvaz
Full name of responsible person
Mohadeseh Bandarrigi
Position
Coach and teacher
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Sadat 7 Alley, Estakhr Ave, Sabzabad street, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7516794754
Phone
+98 77 3344 7040
Fax
Email
m-bandarrigi@stu.scu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The university of Ahvaz
Full name of responsible person
Mohadeseh Bandarrigi
Position
Coach and teacher
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Sadat 7 Alley, Estakhr Ave, Sabzabad street, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7516794754
Phone
+98 77 3344 7040
Fax
Email
m-bandarrigi@stu.scu.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
Yes - There is 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
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The resulting data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Candidates present in the study and people for further research can access the data, and the data can also be used to participate in congresses or other articles.
From where data/document is obtainable
To the first author or the responsible author
What processes are involved for a request to access data/document
Each of the parts of the documents that are allowed to be accessed will be reviewed by announcing the request, after clarifying and receiving the necessary documents.
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