Determining the effect of exercise counseling on the quality of life of the students with polycystic ovary syndrome in Hamadan city universities
Design
A controlled clinical trial with randomized parallel groups on students with polycystic ovary syndrome
Settings and conduct
Notifications are posted in the student dormitories of universities in Hamedan city in Iran and students with polycystic ovary syndrome who wish to participate in the study are requested to call the phone number mentioned in the notice. After obtaining informed consent, they will be asked to complete the demographic questionnaire and the World Health Organization Quality of Life Short Questionnaire (WHO-QOL-BREF) and the Iranian version of the Health-Related Quality of Life Questionnaire for Polycystic Ovary Syndrome (MPCOSQ) in a self-report manner. Intervention group (in groups of 10-15 people) will be counseled for 2 weeks; 2 times a week and they will do sports exercises for 45 to 60 minutes under the supervision of the trainer. Then the students will do sports exercises at their residence for a period of 4 months and 3 times a week. To ensure compliance with the exercise regimen during this period, the researcher will send SMS reminders and place 2-3 weekly phone calls.
Participants/Inclusion and exclusion criteria
Participants: 18-35-year-old students with polycystic ovary syndrome who are not pregnant or breastfeeding; have no known mental or medical illness and physical disability; do not use hormonal drugs, and do not exercise regularly.
Intervention groups
Randomly for the intervention group, sports counseling will be done in groups of 10-15 people for 2 weeks, and then they will do sports exercises at their residence for 4 months and 3 times a week. The control group will continue their normal daily routine.
Main outcome variables
Quality of life (general); Health-related quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240326061367N1
Registration date:2024-04-26, 1403/02/07
Registration timing:registered_while_recruiting
Last update:2024-04-26, 1403/02/07
Update count:0
Registration date
2024-04-26, 1403/02/07
Registrant information
Name
Rafat Bakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0535
Email address
r.bakht@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-19, 1403/01/31
Expected recruitment end date
2024-09-04, 1403/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of exercise counseling on the quality of life of students with polycystic ovary syndrome
Public title
The effect of exercise counseling on the quality of life of students with polycystic ovary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
She has polycystic ovary syndrome
She should be 18 to 35 years old
She should be physically and mentally able to do exercise
Exclusion criteria:
She is pregnant or breastfeeding
According to her own statement, she has known medical diseases such as: diabetes, Cushing's syndrome, hyperplasia of adrenal glands, high blood pressure, thyroid disorders, hyperprolactinemia
According to her own statement, she has a mental illness
She uses hormonal contraceptives or drugs
She has physical disability, deafness, and blindness
She exercise regularly during the week
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Four control and intervention dormitories will be randomly selected from the girls' dormitories of the universities in Hamadan city, and from each dormitory, people will be randomly assigned to the intervention groups of 10-15 people (50 people) or the control group (50 people).
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 Hamadan University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Approval date
2024-03-08, 1402/12/18
Ethics committee reference number
IR.UMSHA.REC.1402.768
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Quality of life
Timepoint
Measuring the quality of life at the beginning of the study and 2 months and 4 months after the study
Method of measurement
The short version of the world health organization quality of life instrument (WHO-QOL-BREF) and the Iranian version of health-related quality of life polycystic ovary syndrome questionnaire (MPCOSQ)
Secondary outcomes
empty
Intervention groups
1
Description
Students with polycystic ovary syndrome living in the dormitories of universities in Hamadan, who are randomly assigned to the intervention group, are asked to complete demographic and quality of life questionnaires. Then, they will be given exercise counseling in groups (in groups of 10-15 people) for 2 weeks and they will do exercises (which were taught by the trainer) at their residence for 4 months and 3 sessions every week. They are also asked to complete the quality of life questionnaires 2 months and 4 months after the consultation.
Category
Lifestyle
2
Description
Control group: Students with polycystic ovary syndrome living in the dormitories of universities in Hamadan city, who are randomly placed in the control group, are asked to complete the demographic and quality of life questionnaires before studying and quality of life questionnaires 2 , 4 months after the intervention group's exercise counseling.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitories of universities in Hamadan city
Full name of responsible person
Solmaz Javadi Yeganeh
Street address
Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
dr.solmazzz.yeganeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokoohi
Street address
Shadid Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Web page address
https://research.umsha.ac.i
Grant name
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Rafat bakht
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
rbakht@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rafat Bakht
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
rbakht@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rafat Bakht
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
rbakht@yahoo.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In case of the approval of Hamشdan University of Medical Sciences, the individual data of the participants (non-identifiable) and the summary report of the methods and results of the study without data analysis will be provided to the participants and researchers who request it.
When the data will become available and for how long
If Hamadan University of Medical Sciences agrees, the access period will start 6 months after the publication of the results
To whom data/document is available
Participants and requesting researchers
Under which criteria data/document could be used
In order to increase the awareness and improve the health level of the participants from the results of the study in which they participated and the researchers to use it in the design of studies in the future
From where data/document is obtainable
Hamedan University of Medical Sciences Research and Technology Vice-Chancellor
What processes are involved for a request to access data/document
Submitting an application to the Research and Technology Vice-Chancellor of Hamadan University of Medical Sciences, submitting the application to the University Research Council, and in case of approval, providing the data files and a summary report of the methodology and study findings to the participants