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The effect of eight weeks of Pilates exercise and jujube supplementation on liver fat content, liver enzymes and platelet count in women with non-alcoholic fatty liver

Protocol summary

Study aim
Determining the effect of eight weeks of Pilates training and jujube extract supplementation on non-alcoholic fatty liver and platelet count in middle-aged women
Design
Clinical trial with randomized open label, parallel control group, on 40 people in four groups.
Settings and conduct
Ultrasound to diagnose fatty liver, liver tests including AST-ALT-ALP- and CBC test to determine platelet levels will be performed 48 hours before and after the intervention for all people. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. The first group will be given only jujube, the second group will only have Pilates exercises, the third group will have jujube and Pilates, and the fourth group will be the control group, which will not be interfered with.
Participants/Inclusion and exclusion criteria
Satisfaction with the study, middle-aged women aged Benin 31 to 49 years, no history of other diseases, no alcohol and tobacco use, no special diet / medication, no dietary supplements, no regular exercise in the past six months Lack of BMI above 30 and fatty liver level one and higher.
Intervention groups
We will have four intervention groups: the first group will only consume jujube The second group will only practice Pilates The third group is the jujube consumption group of Pilates exercises. The fourth group is the control group that will not be interfered with.
Main outcome variables
Main outcomes include liver fat analysis, liver enzymes and platelet count.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210413050954N1
Registration date: 2021-08-31, 1400/06/09
Registration timing: retrospective

Last update: 2021-08-31, 1400/06/09
Update count: 0
Registration date
2021-08-31, 1400/06/09
Registrant information
Name
Rasoul Raesi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5422 6054
Email address
raeesigr2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of Pilates exercise and jujube supplementation on liver fat content, liver enzymes and platelet count in women with non-alcoholic fatty liver
Public title
The effect of eight weeks of Pilates exercise and jujube supplementation on liver fat content, liver enzymes and platelet count in women with non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Middle-aged women ranging in age from 31 to 49 Satisfaction to participate in the study BMI 30 or less Fatty liver grade one and above
Exclusion criteria:
History of other diseases Alcohol and tobacco consumption Special diet / medication Take dietary supplements Regular exercise in the last six months
Age
From 31 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The lottery method will be used for random allocation. This method is a large block the size of the total sample size to ensure a balance in the number of people assigned to each group. For this purpose, we put the same size of the sample (40 pieces) of the same shape card on which the numbers 1 to 40 are written in the same shape of the envelope and place it in a lottery container. Then randomly remove the cards and number the first 10 cards for group A (Pilates exercise), the next 10 cards for group B (Pilates and jujube), the third 10 cards for group C (jujube only) and the last 10 cards for group D (Control group) is written, the random chain of numbers and assigned groups are specified. Candidates are numbered in order of date and assigned to the groups based on the written sequence.
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 Mashhad University of Medical Sciences
Street address
modarres 15
City
khaf
Province
Razavi Khorasan
Postal code
9561717551
Approval date
2021-06-19, 1400/03/29
Ethics committee reference number
IR.MUMS.REC.1400.078

Health conditions studied

1

Description of health condition studied
non-alcoholic fatty liver
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
liver fat content
Timepoint
48 hours before the intervention and 48 hours after the intervention
Method of measurement
Diagnostic ultrasound of fatty liver

2

Description
Liver enzymes
Timepoint
48 hours before the intervention and 48 hours after the intervention
Method of measurement
Blood biochemistry tests

3

Description
Platelet count
Timepoint
48 hours before the intervention and 48 hours after the intervention
Method of measurement
Blood Cell Counting Test (CBC)

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group, only jujube consumption: daily consumption of 0.4 grams of jujube fruit per kilogram of body weight will be consumed in the morning and the same amount in the evening.
Category
Treatment - Drugs

2

Description
The second intervention group, Pilates Exercise Only: The Pilates training protocol will include 60 minutes of activity in the form of 10 minutes of warm-up, 40 minutes of Pilates exercises, and 10 minutes of cooling in three sessions per week for eight weeks. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. It is done lying down and without the need for specialized equipment. In order to observe the principle of overload, the speed and repetition of movements in each session will increase compared to the previous session, so that it starts from 10 repetitions in the first week and will gradually reach 25-25 repetitions in the eighth week. Also, to control the intensity of the exercises, the formula of maximum heart rate (age -220 = maximum heart rate) and polar heart rate monitor will be used. Accordingly, exercise will begin in the first week with an intensity of 55-50% of maximum heart rate and in the eighth week will reach 75-80% of maximum heart rate (approximately 5% increase in intensity of exercise per week). It should be noted that the control group and the jujube extract group will not participate in any training or sports activities during these eight weeks.
Category
Treatment - Other

3

Description
Intervention group: The third intervention group, Pilates training and jujube consumption: will consume 0.4 grams of jujube fruit per kilogram of body weight daily in the morning and the same amount in the evening. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. It is done lying down and without the need for specialized equipment. In order to observe the principle of overload, the speed and repetition of movements in each session will increase compared to the previous session, so that it starts from 10 repetitions in the first week and will gradually reach 25-25 repetitions in the eighth week. Also, to control the intensity of the exercises, the formula of maximum heart rate (age -220 = maximum heart rate) and polar heart rate monitor will be used. Accordingly, exercise will begin in the first week with an intensity of 55-50% of maximum heart rate and in the eighth week will reach 75-80% of maximum heart rate (approximately 5% increase in intensity of exercise per week). It should be noted that the control group and the jujube extract group will not participate in any training or sports activities during these eight weeks.
Category
Treatment - Other

4

Description
Control group: they will not be interfered with.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
22 Bahman Khaf Hospital
Full name of responsible person
rasoul raesi
Street address
Moallem Square, Ferdowsi Blvd., 22 Bahman Khaf Hospital
City
khaf
Province
Razavi Khorasan
Postal code
9561717551
Phone
+98 51 5422 9501
Email
raesi.br881@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud School of Physical Education
Full name of responsible person
rasoul raesi
Street address
Hafdeh Shahrivar St., Behzisti Alley, Mirabotaleb Dormitory
City
Shahroud
Province
Semnan
Postal code
00000000000000000000
Phone
+98 23 3224 1019
Email
raesi.br881@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
no
Proportion provided by this source
1
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
Mashhad University of Medical Sciences
Full name of responsible person
rasoul raesi
Position
nurse
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
modarres15
City
khaf
Province
Razavi Khorasan
Postal code
9561717551
Phone
+98 51 5422 9501
Email
raesi.br881@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
rasoul raesi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
modarres15
City
khaf
Province
Razavi Khorasan
Postal code
9561717551
Phone
+98 51 5422 6054
Email
raesi.br881@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
rasoul raesi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
modares15
City
khaf
Province
Razavi Khorasan
Postal code
9561717551
Phone
+98 51 5422 6054
Email
raesi.br881@gmail.com

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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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