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The effect of Water-Based rhythmic exercise training on Leptin, Aldosterone and Cardiovascular risk factors in postmenopausal women with Metabolic Syndrome

Protocol summary

Study aim
The effect of Water-Based rhythmic exercise training on Leptin, Aldosterone and cardiovascular risk factors in Postmenopausal women with Metabolic Syndrome
Design
in the research, 40 postmenopausal women with metabolic syndrome voluntarily will be divided into two groups; 20 people in experimental and 20 people in control group.
Settings and conduct
The present study is a semi-experimental study among the postmenopausal women with metabolic syndrome of city of Rasht for 12 weeks. Blood sampling is performed after 12 hours of fasting and before and after 12 weeks ofWater-Based rhythmic exercise training.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having age ranges of 65-75 years, Postmenopausal, No regular exercise, Suffering from at least three of the five indicators of metabolic syndrome: abdominal obesity (waist circumference more than 88 cm), triglycerides greater than 150 mg/dl, blood pressure more than 130.85 ml of mercury, fasting blood glucose more than 110 ml/dl And high-density lipoprotein (HDL) less than 50 mg/dl and Lack of diabetes, liver, kidney, inflammation and respiratory diseases. Exclusion criteria: More than three session absence from the training, injury during training
Intervention groups
Intervention group: Water-Based rhythmic exercise training group: Twelve weeks, three times per week. Water-Based rhythmic exercise training were performed with an intensity of 50-75% of maximum heart rate Control group: Without intervention
Main outcome variables
Leptin, Aldosterone, Albumin, Systolic and Diastolic blood Pressure, hs-CRP, fasting blood sugar, insulin, insulin resistance, TG, TC, LDL-C, HDL, body fat percentage, Body Mass Index and Waist Circumference

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200625047917N1
Registration date: 2020-06-28, 1399/04/08
Registration timing: prospective

Last update: 2020-06-28, 1399/04/08
Update count: 0
Registration date
2020-06-28, 1399/04/08
Registrant information
Name
Hanieh Berahman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3212 4813
Email address
hani.berahman@phd.iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-30, 1399/04/10
Expected recruitment end date
2020-10-01, 1399/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Water-Based rhythmic exercise training on Leptin, Aldosterone and Cardiovascular risk factors in postmenopausal women with Metabolic Syndrome
Public title
The effect of Water-Based rhythmic exercise training in postmenopausal women with Metabolic Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having age ranges of 65-75 years Postmenopausa No regular exercise Suffering from at least three of the five indicators of metabolic syndrome: abdominal obesity (waist circumference more than 88 cm), triglycerides greater than 150 mg / dl, blood pressure more than 130.85 ml of mercury, fasting blood glucose more than 110 ml / dl And high-density lipoprotein (HDL) less than 50 mg / dl Lack of diabetes, liver, kidney, inflammation and respiratory diseases
Exclusion criteria:
More than three session absence from the training injury during training
Age
From 65 years old to 75 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
Subjects were divided into two groups (one control group and one experimental group) using the simple random method. This sampling will be done based on the red and blue balls inside the box that are randomly taken by the subjects (the red ball of the control group and the blue ball of the experimental group).
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 Islamic Azad University Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Approval date
2020-06-22, 1399/04/02
Ethics committee reference number
IR.IAU.RASHT.REC.1399.022

Health conditions studied

1

Description of health condition studied
Metabolic Syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome

Primary outcomes

1

Description
Aldosterone
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit

2

Description
Leptin
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit

3

Description
High-sensitivity C-reactive Protein (hs-CRP)
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit

4

Description
Fast blood sugar
Timepoint
Before and after the end of interventions
Method of measurement
using ELISA Kit

5

Description
Blood pressure
Timepoint
Before and after the end of interventions
Method of measurement
Using the blood pressure device

6

Description
Insulin hormone
Timepoint
Before and after the end of interventions
Method of measurement
Serum levels using Eliza method

7

Description
Albumin
Timepoint
Before and after the end of interventions
Method of measurement
Using Colorimetric

8

Description
Triglyceride
Timepoint
Before and after the end of interventions
Method of measurement
According to milligrams per deciliter and by Baseline blood

9

Description
Low-density lipoprotein
Timepoint
Before and after the end of interventions
Method of measurement
According to milligrams per deciliter and by Baseline blood

10

Description
High-density lipoprotein
Timepoint
Before and after the end of interventions
Method of measurement
According to milligrams per deciliter and by Baseline blood

11

Description
Cholstrol
Timepoint
Before and after the end of interventions
Method of measurement
According to milligrams per deciliter and by Baseline blood

12

Description
Waist circumference
Timepoint
Before and after the end of interventions
Method of measurement
According to cm and by Tape measure

13

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

14

Description
Fat percent
Timepoint
Before and after the end of interventions
Method of measurement
Using InBody

Secondary outcomes

1

Description
TSH
Timepoint
before and after the end of intervention
Method of measurement
using ELISA Kit

2

Description
T4
Timepoint
before and after the end of intervention
Method of measurement
using ELISA Kit

Intervention groups

1

Description
Intervention group:12 weeks of Water-Based rhythmic exercise training ,three sessions per week, 60 minutes each session. Exercise training program consists of 10 minutes warming up, 45 minutes Water-Based rhythmic exercise training and 5 minutes cooling down
Category
Lifestyle

2

Description
Control group: Without intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Golsar Hospital
Full name of responsible person
Hanie Berahman
Street address
Golsar Hospital, Golsar Street
City
Rasht
Province
Guilan
Postal code
4153911900
Phone
+98 13 4466 5179
Email
hanie_berahman@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Delpasand
Street address
Rasht Branch, Islamic Azad University, Taleshan Bridge
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
hanie_berahman@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Hanieh Berahman
Position
PhD student
Latest degree
Master
Other areas of specialty/work
exercise physiology
Street address
Rasht Branch, Islamic Azad University, Taleshan Bridge
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
hanie_berahman@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Alireza Elmiyeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Lakan St., Poltaleshan Blv. , Rasht, Gilan, Iran
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
elmieh@iaurasht.acir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Haniye Berahman
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Rasht Branch, Islamic Azad University, Taleshan Bridge
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
hanie_berahman@yahoo.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
No decision has been made yet.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
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