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The effect of 12 weeks of exercise in water on some hormonal, metabolic and morphological indicators of women with polycystic ovaries and hypothyroidism

Protocol summary

Study aim
The purpose of this research is to investigate the effect of 12 weeks of exercise in water on some hormonal, metabolic and morphological indicators of women with polycystic ovaries and hypothyroidism.
Design
The participants will be randomly divided into intervention and control groups. Blinding has been done for the patients and the radiologist and pathologist reporting the results.
Settings and conduct
30 people will be randomly divided into two intervention and control groups . they were blinded in terms of being in the intervention and control groups. The radiologist and pathologist are blinded. The height and weight of these patients will be measured and the quality of life questionnaire will be filled.Evaluation of aerobic capacity and physical performance, antimullerin hormones, prolactin, TSH, FSH, LH and glucose and fasting insulin, LDH HDL, TG and ultrasound to check the volume of the ovary and the number of follicles will be done in Imam Reza clinic. Exercise in water For 12 weeks, both groups will be subjected to physical evaluation, aerobic capacity, quality of life Questionnaires, ultrasound and blood tests.
Participants/Inclusion and exclusion criteria
1. Having at least 2 of the 3 Rotterdam criteria 2.with subclinical hypothyroidism 3. BMI<23 4.Not an athlete 5. Age range from 18 to 30 years
Intervention groups
Water training for 12 weeks will include 20 minutes of walking in water forward, backward, sideways and soft running in the shallow part of the pool where the water is up to neck level, then plyometric exercises in water will include long jump and height, shooting a soccer ball, throwing a soccer ball, climbing the pool stairs for 10 minutes, repeating each movement 10 times with a 30-second rest between each exercise.
Main outcome variables
Morphological and hormonal indicators and physical performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161029030544N2
Registration date: 2024-05-09, 1403/02/20
Registration timing: retrospective

Last update: 2024-05-09, 1403/02/20
Update count: 0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Shabnam Talebi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3662 1350
Email address
talebishabnam62@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-03-21, 1403/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 12 weeks of exercise in water on some hormonal, metabolic and morphological indicators of women with polycystic ovaries and hypothyroidism
Public title
The effect of exercise in water on women with polycystic ovaries and hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 2 of the 3 criteria of Rotterdam Suffering from subclinical hypothyroidism Not having regular sports activity in the last three months Age range from 18 to 30 years BMI<23
Exclusion criteria:
Suffering from cardiovascular diseases, skin diseases, rheumatism, kidney and liver diseases BMI>23 suffering from muscular and skeletal diseases or physical disabilities taking any kind of contraceptive pills being an athlete
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple block randomization: In this study, even numbers from one to ten were written on paper and placed in a container. The participants who entered the study according to the entry criteria chose one of the numbers inside the container upon entering. Two blocks of 15 people were considered, the first block of the intervention group and the second block of the control group, where people were randomly placed in block 1 by choosing even numbers and in block 2 by choosing odd numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants do not know whether they are in the intervention group or the control group. In addition, the patients in the control group and the radiologist and the laboratory are not aware of the existence of hydrotherapy intervention, and the results evaluator, the radiologist and the laboratory experts examining the samples, do not know which participant They do not know which nodes are in the intervention group and which are in the control group
Placebo
Not used
Assignment
Parallel
Other design features
In this study, accurate ultrasound tools and laboratory findings will be used to evaluate the effects of the intervention

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan Islamic Azad University
Street address
sheikh sadoogh Ave
City
isfahan
Province
Isfehan
Postal code
8163849441
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.183

Health conditions studied

1

Description of health condition studied
polycystic ovaries and hypothyroidism
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
morphological indicators: Ovarian volume and number of follicles
Timepoint
At the beginning of the study before the intervention and at the end of the study after the intervention
Method of measurement
Ultrasound machine

2

Description
some hormonal indicators
Timepoint
At the beginning of the study before the intervention and at the end of the study after the intervention
Method of measurement
Laboratory kits in the laboratory

3

Description
Fasting blood sugar and insulin and lipid profile
Timepoint
At the beginning of the study before the intervention and at the end of the study after the intervention
Method of measurement
Laboratory kits in the laboratory

4

Description
Aerobic power and physical performance
Timepoint
At the beginning of the study before the intervention and at the end of the study after the intervention
Method of measurement
One Minute Sit and Stand Test and One Mile Walk Rockport Test

Secondary outcomes

1

Description
some hormonal indicators, metabolic indicators
Timepoint
At the beginning before the intervention and at the end after the intervention
Method of measurement
Blood test

2

Description
morphological indicators
Timepoint
At the beginning before the intervention and at the end after the intervention
Method of measurement
Ultrasound machine

Intervention groups

1

Description
Intervention group: Exercise in water for 12 weeks. including 20 minutes of walking in the water forward, backward, sideways and soft running in the shallow part of the pool where the water height is up to the neck, then plyometric exercises in the water including long and high jump, shooting soccer balls, Throwing a soccer ball, climbing the pool stairs will be done for 10 minutes, repeating each movement 10 times with 30 seconds rest between each exercise.
Category
Treatment - Other

2

Description
Control group: Control group: In the control group, no intervention is done, only they are asked not to take any special medicine and not to do any special sports activity during the study period.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam reza hospital
Full name of responsible person
Shabnam talebi khorzooghy
Street address
Sheikh sadoogh Ave
City
Isfahan
Province
Isfehan
Postal code
8163849441
Phone
+98 31 3662 1350
Email
Talebishabnam62@gmail.com

2

Recruitment center
Name of recruitment center
Private obstetrics and gynecology offices
Full name of responsible person
Shabnam talebi khorzooghy
Street address
Sheikh sadoogh Ave
City
Isfahan
Province
Isfehan
Postal code
8163849441
Phone
+98 31 3662 1350
Email
Talebishabnam62@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President of Research, Islamic Azad University, Khorasgan branch
Full name of responsible person
ShabnamTalebi Khorzooghy and Khosro Jalali Dehkordy
Street address
Sheikh Sadoogh Ave
City
Isfahan
Province
Isfehan
Postal code
8163849441
Phone
+98 31 3662 1350
Email
Talebishabnam62@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research, Islamic Azad University, Khorasgan branch
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
Shabnam Talebi Khorzooghy
Position
phd student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sheihk Sadoogh Ave
City
Isfahan
Province
Isfehan
Postal code
8163849441
Phone
+98 31 3662 1350
Email
talebishabnam62@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shabnam Talebi khorzooghi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sheikh Sadoogh Ave
City
Isfahan
Province
Isfehan
Postal code
8163849441
Phone
+98 31 3662 1350
Email
Talebishabnam62@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shabnam Talebi Khorzooghy
Position
phd student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sheikh Sadoogh Ave
City
Isfahan
Province
Isfehan
Postal code
8163849441
Phone
+98 31 3662 1350
Email
Talebishabnam62@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the study comparing the findings of ultrasound and blood tests and questionnaires before and after the intervention will be done without mentioning the details of the data, which will allow other researchers to use the data.
When the data will become available and for how long
since 2024
To whom data/document is available
Supervisors, reviewers of journals that print articles, university reviewers
Under which criteria data/document could be used
In order to check the correctness and accuracy of research work
From where data/document is obtainable
To me as a doctoral student conducting a research project
What processes are involved for a request to access data/document
Contact me by email talebishabnam62@gmail.com, any part of the data that is needed to clear the ambiguity will be emailed to them.
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