Exercise Programs in Women With PCOS
ConditionPolycystic Ovarian Syndrome (PCOS)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorBiruni University
About this trial
This study aims to investigate the effectiveness of a digital rehabilitation-supported combined exercise program in women with Polycystic Ovary Syndrome (PCOS). Participants aged 18-40 years will be randomly assigned to one of three groups: a digital rehabilitation group, a face-to-face exercise group, and a physical activity counseling group. The intervention will last 8 weeks, with exercise performed three times per week. Outcomes will include DNA methylation, hormonal and metabolic parameters, anthropometric measurements, body composition, muscle strength, basal metabolic rate, physical activity level, quality of life, menstrual cycle regularity, exercise adherence and satisfaction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18-40 years diagnosed with PCOS according to the Rotterdam criteria (Rotterdam, 2003) and by a specialist physician.
Having sufficient technological skills to participate in the treatment online (ability to use video conferencing applications)
Voluntary participation in the study
Disqualifiers
Pregnant and breastfeeding women
Individuals with acute infections
Uncontrolled arrhythmia, hypertension, diabetes, and unstable angina pectoris
Impaired cooperation, orthopedic and neurological problems that may hinder assessment and program participation
Trial design
Design model
Parallel
Treatments tested in this trial
Face-to-face exercise
BehavioralParticipants will perform the same combined exercise program (aerobic and resistance exercises) delivered in person by the study team. Sessions are supervised directly in a clinical setting.
Digital rehabilitation
BehavioralParticipants will perform a combined exercise program (aerobic and resistance exercises) through a digital rehabilitation platform.
Treatment groups
33 Participants
are divided into 3 treatment groupsGroup A: Face-to-face Exercise GroupExperimental treatment 1 intervention
Group B: Digital Rehabilitation GroupExperimental treatment 1 intervention
Group C: Physical Activity Counseling GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in DNA methylation levels in women with PCOS
Genome-wide DNA methylation analysis will be used to measure methylation in blood samples taken baseline and after 8 weeks.
Time frame
Baseline and after 8 weekSecondary outcomes
1
Hormonal Parameter Testosterone
Serum levels of testosterone will be measured at baseline and after 8 weeks.
Time frame
Baseline and after 8 weeks.2
Hormonal Parameter Luteinizing Hormone
Serum levels of luteinizing hormone (LH) will be measured at baseline and after 8 weeks.
Time frame
Baseline and after 8 weeks3
Hormonal Parameter Follicle-Stimulating Hormone
Serum levels of follicle-stimulating hormone (FSH) will be measured at baseline and after 8 weeks.
Time frame
Baseline and after 8 weeks4
Metabolic Parameter Fasting Blood Glucose
For the evaluation of fasting blood glucose (FPG) will be measured in all participants baseline and after 8 weeks.
Time frame
Baseline and after 8 weeksSponsors and contacts
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Source ClinicalTrials.gov
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