Protocol summary
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Study aim
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Evaluation of the effect of exercise training on anthropometric status, some metabolic, inflammatory and oxidative stress profiles of women with polycystic ovary syndrome.
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Design
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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).
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Lipid profile; Fasting blood Glucose; Insulin; Insulin resistance (HOMA-IR), Maximum oxygen consumption (V̇O₂ max)
General information
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Reason for update
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Change in proposal
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130812014333N143
Registration date:
2020-03-22, 1399/01/03
Registration timing:
prospective
Last update:
2022-10-23, 1401/08/01
Update count:
2
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Registration date
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2020-03-22, 1399/01/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-02, 1399/01/14
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Expected recruitment end date
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2020-10-05, 1399/07/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effect of exercise on anthropometric status, some metabolic and inflammatory profiles of women with polycystic ovary syndrome.
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Public title
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Evaluation of the effect of exercise on women with polycystic ovary syndrome status.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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"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."
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-03, 1398/11/14
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Ethics committee reference number
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ir.kums.rec.1398.1186
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Insulin resistance
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Timepoint
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Beginning and end of the study (after 8 weeks)
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Method of measurement
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Standard formula
2
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Description
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Maximum oxygen consumption (V̇O₂ max)
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Timepoint
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Beginning and end of the study (after 8 weeks)
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Method of measurement
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Standard formula
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
3
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Description
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The control group will receive no intervention
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The main outcomes of the study will be shared.
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When the data will become available and for how long
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6 months
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To whom data/document is available
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If requested, results will be made available to other academic researchers
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Under which criteria data/document could be used
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Collected data is confidential and will not be shared with anyone else
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From where data/document is obtainable
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Send E-mail to the responsible for the update to get the documentation
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What processes are involved for a request to access data/document
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Documentation will be emailed within a 15-day timeframe
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Comments
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