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General information
Other
Parallel
otherparal
3
N/A
3na
90
45
9045
Using the random number table. It means the first 30 numbers that randomly are selected in the first stage will be assigned to the first group. 30 numbers that randomly are selected in the second stage will be assigned to the second group, and 30 numbers that randomly are selected in the third stage will be assigned to the third group.
"Randomization was done from a computer-generated sequence(random number generator software), concealed in sequentially numbered, sealed, opaque envelopes(SNOSE method), and kept by the Clinic technician of the two centres."
Using the random"Randomization was done from a computer-generated sequence(random number table. It means the first 30 numbers that randomly are selectedgenerator software), concealed in the first stage will be assigned to the first group. 30 numbers that randomly are selected in the second stage will be assigned to the second groupsequentially numbered, sealed, opaque envelopes(SNOSE method), and 30 numbers that randomly are selected inkept by the third stage will be assigned toClinic technician of the third grouptwo centres."
با استفاده از جدول اعداد تصادفی. به این صورت که 30 عددی که در مرحله اول به صورت تصادفی انتخاب می شود به گروه اول اختصاص داده می شود. 30 عددی که در مرحله دوم به صورت تصادفی انتخاب می شود به گروه دوم، 30 عددی که در مرحله سوم به صورت تصادفی انتخاب می شود به گروه سوم، اختصاص داده می شود.
ابتدا توالی تصادفی به وسیله نرم افزار تولید تصادفی انجام می پذیرد سپس بر اساس حجم نمونه پژوهش تعدادی پاکت نامه تهیه می شود .هریک از توالی های تصادفی گروه ها بر روی کارتی ثبت می شود و در داخل پاکت قرار داده می شود. سطح خارجی پاکت ها هم به ترتیب توالی تصادفی شماره گذاری می گردد و درب پاکت های نامه چسبانده می شود. در زمان شروع ثبت نام شرکت کنندگان بر اساس ترتیب ورود شرکت کنندگان واجد شرایط به مطالعه یک پاکت نامه به آن تخصیص داده می شود و پاکت باز شده و گروه آن شرکت کننده مشخص می گردد.
با استفاده از جدول اعدادابتدا توالی تصادفی. به این صورت که 30 عددی که در مرحله اول به صورتوسیله نرم افزار تولید تصادفی انتخابانجام می پذیرد سپس بر اساس حجم نمونه پژوهش تعدادی پاکت نامه تهیه می شود به.هریک از توالی های تصادفی گروه اول اختصاصها بر روی کارتی ثبت می شود و در داخل پاکت قرار داده می شود. 30 عددی که در مرحله دومسطح خارجی پاکت ها هم به صورتترتیب توالی تصادفی انتخابشماره گذاری می گردد و درب پاکت های نامه چسبانده می شود. در زمان شروع ثبت نام شرکت کنندگان بر اساس ترتیب ورود شرکت کنندگان واجد شرایط به گروه دوم، 30 عددی که در مرحله سوممطالعه یک پاکت نامه به صورت تصادفی انتخاب می شود به گروه سوم، اختصاصآن تخصیص داده می شود و پاکت باز شده و گروه آن شرکت کننده مشخص می گردد.
Intervention groups
#1
Treatment - Other
Other
treatment-other
The fifth intervention group will receive 40 grams of oat supplement of with resistance training at 50% 1RM twice a week for 8 weeks
The control group will receive no intervention
The fifth interventioncontrol group will receive 40 grams of oat supplement of with resistance training at 50% 1RM twice a week for 8 weeksno intervention
گروه مداخله پنجم روزانه 40 گرم مکمل یولاف با تمرینات مقاومتی با شدت %50 1RM دوبار در هفته به مدت 8 هفته دریافت خواهند کرد.
گروه کنترل هیچ مداخله ای دریافت نخواهند کرد.
گروه کنترل هیچ مداخله پنجم روزانه 40 گرم مکمل یولاف با تمرینات مقاومتی با شدت %50 1RM دوبار در هفته به مدت 8 هفتهای دریافت خواهندنخواهند کرد.
#2
Other
empty
other
The control group will receive no intervention
empty
The control group will receive no intervention
گروه کنترل هیچ مداخله ای دریافت نخواهند کرد.
empty
گروه کنترل هیچ مداخله ای دریافت نخواهند کرد.
Protocol summary
Study aim
Evaluation of the effect of exercise training on anthropometric status, some metabolic, inflammatory and oxidative stress profiles of women with polycystic ovary syndrome.
Design
This study is an open-label clinical trial. The study population will be all women with polycystic ovary syndrome referred to Imam Reza hospital of Kermanshah. 90 eligible patients will be selected conveniently and randomly assigned to 3 intervention and control groups (2 intervention groups and one control group).
Settings and conduct
This study that will be conducted in Imam Reza hospital of Kermanshah is a double-blind one that , researchers and data analysts were kept blind to the allocation of study groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome; Age between 18 to 40 years
Exclusion criteria: Taking oral contraceptives; Taking hormone drugs affecting total testosterone levels over the past three months
Intervention groups
The first intervention group will receive alternative training with 50 to 110 percent maximum aerobic velocity (MAV) three times a week for 8 weeks with a treadmill. The second intervention group will receive combination of aerobic and resistance training with 50% to 70% 1RM and 50% to 70% maximum heartbeat rate (MHR) three times a week for 8 weeks. The control group will receive no intervention.
Evaluation of the effect of exercise on anthropometric status, some metabolic and inflammatory profiles of women with polycystic ovary syndrome.
Public title
Evaluation of the effect of exercise on women with polycystic ovary syndrome status.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with polycystic ovary syndrome
Age between 18 to 40 years
Exclusion criteria:
Taking oral contraceptives
Taking hormone drugs affecting total testosterone levels over the past three months
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
"Randomization was done from a computer-generated sequence(random number generator software), concealed in sequentially numbered, sealed, opaque envelopes(SNOSE method), and kept by the Clinic technician of the two centres."
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 Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
ir.kums.rec.1398.1186
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
Insulin resistance
Timepoint
Beginning and end of the study (after 8 weeks)
Method of measurement
Standard formula
2
Description
Maximum oxygen consumption (V̇O₂ max)
Timepoint
Beginning and end of the study (after 8 weeks)
Method of measurement
Standard formula
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group, will receive alternative training with 50 to 110 percent maximum aerobic velocity (MAV) three times a week for 8 weeks with a treadmill.
Category
Treatment - Other
2
Description
The second intervention group will receive a combination of aerobic and resistance training with 50% to 70% 1RM and 50% to 70% maximum heartbeat rate (MHR) three times a week for 8 weeks.
Category
Treatment - Other
3
Description
The control group will receive no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Solmaz Alavi Milani
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
s.alavimilani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Solmaz Alavi Milani
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
s.alavimilani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Solmaz Alavi Milani
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
s.alavimilani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Solmaz Alavi Milani
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
s.alavimilani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 15-day timeframe