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NCT Number: NCT07509762

Exercise Programs in Women With PCOS

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.

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Key information

Conditions

Polycystic Ovarian Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, 34015, Turkey (Türkiye)

About this study

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder associated with metabolic, hormonal, and reproductive dysfunctions. Exercise is a key component in the management of PCOS; however, adherence to exercise programs remains a major challenge.

This randomized controlled trial aims to evaluate the effectiveness of a digital rehabilitation-supported combined exercise program compared to face-to-face supervised exercise and physical activity counseling.

Participants aged 18-40 years will be randomly assigned into three groups:

  • Face-to-face exercise group
  • Digital rehabilitation group
  • Physical activity counseling group The intervention will last for 8 weeks, with exercise sessions conducted three times per week.

The face-to-face group will participate in supervised exercise sessions conducted by physiotherapist. The digital rehabilitation group will perform the same exercise protocol as the face-to-face group group online, live (synchronously), under the guidance of physiotherapist. The counseling group will receive physical activity recommendations.

Outcome measures will include epigenetic changes (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18-40 years diagnosed with PCOS according to the Rotterdam criteria (Rotterdam, 2003) and by a specialist physician.

The presence of at least two of the following three criteria will be considered sufficient for a diagnosis of PCOS according to the Rotterdam criteria: (i) history of irregular menstruation with oligo/anovulation, (ii) clinical and/or biochemical signs of hyperandrogenism, (iii) detection of polycystic ovary images on ultrasonography.

  • Having sufficient technological skills to participate in the treatment online (ability to use video conferencing applications)
  • Voluntary participation in the study

Exclusion criteria

  • 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
  • Individuals with a history of lower extremity injury or surgery in the last six months
  • Individuals with class III obesity according to WHO classification (BMI > 40 kg/m2) (WHO, 2000)
  • Individuals receiving medical treatment for weight loss (liraglutide, semaglutide, orlistat, bupropion/naltrexone, thizzpatide) or participating in a structured diet program during the study period
  • Individuals actively participating in another exercise program
  • Individuals taking antihypertensive, insulin-sensitizing, or hormonal contraceptive drugs in the last 3 months

Treatment and study plan

Face-to-face exercise

Behavioral

Participants 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

Behavioral

Participants will perform a combined exercise program (aerobic and resistance exercises) through a digital rehabilitation platform.

Primary outcomes

  1. Change in DNA methylation levels in women with PCOS

    Time frame: Baseline and after 8 week

    Genome-wide DNA methylation analysis will be used to measure methylation in blood samples taken baseline and after 8 weeks.

Secondary outcomes

  1. Hormonal Parameter Testosterone

    Time frame: Baseline and after 8 weeks.

    Serum levels of testosterone will be measured at baseline and after 8 weeks.

  2. Hormonal Parameter Luteinizing Hormone

    Time frame: Baseline and after 8 weeks

    Serum levels of luteinizing hormone (LH) will be measured at baseline and after 8 weeks.

  3. Hormonal Parameter Follicle-Stimulating Hormone

    Time frame: Baseline and after 8 weeks

    Serum levels of follicle-stimulating hormone (FSH) will be measured at baseline and after 8 weeks.

  4. Metabolic Parameter Fasting Blood Glucose

    Time frame: Baseline and after 8 weeks

    For the evaluation of fasting blood glucose (FPG) will be measured in all participants baseline and after 8 weeks.

  5. Metabolic Parameter Insulin Level

    Time frame: Baseline and after 8 weeks

    For the evaluation of insulin level will be measured in all participants baseline and after 8 weeks.

  6. Metabolic Parameter High-Density Lipoprotein Cholesterol

    Time frame: Baseline and after 8 weeks

    For the evaluation of high-density lipoprotein cholesterol (HDL-C) will be measured in all participants baseline and after 8 weeks.

  7. Metabolic Parameter Low-Density Lipoprotein Cholesterol

    Time frame: Baseline and after 8 weeks

    For the evaluation of low-density lipoprotein cholesterol (LDL-C) will be measured in all participants baseline and after 8 weeks.

  8. Metabolic Parameter Total Cholesterol

    Time frame: Baseline and after 8 weeks

    For the evaluation of total cholesterol will be measured in all participants baseline and after 8 weeks.

  9. Metabolic Parameter Triglycerides

    Time frame: Baseline and after 8 weeks

    For the evaluation of triglycerides will be measured in all participants baseline and after 8 weeks.

  10. Metabolic Parameter C-Reactive Protein

    Time frame: Baseline and after 8 weeks

    For the evaluation of C-reactive protein (CRP) will be measured in all participants baseline and after 8 weeks.

  11. Anthropometric Measurements Waist Circumference

    Time frame: Baseline and after 8 weeks

    Waist circumference will be measured using standardized tape.

  12. Anthropometric Measurements Hip Circumference

    Time frame: Baseline and after 8 weeks

    Hip circumference will be measured using standardized tape.

  13. Body Composition Body Mass Index

    Time frame: Baseline and after 8 weeks

    Participants' BMI will be measured using Bioelectrical Impedance Analysis (BIA).

  14. Body Composition Body Fat Mass

    Time frame: Baseline and after 8 weeks

    Participants' body fat mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).

  15. Body Composition Body Fat Percentage

    Time frame: Baseline and after 8 weeks

    Participants' body fat percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA).

  16. Body Composition Body Muscle Percentage

    Time frame: Baseline and after 8 weeks

    Participants' body muscle percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA).

  17. Body Composition Body Muscle Mass

    Time frame: Baseline and after 8 weeks

    Participants' body muscle mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).

  18. Body Composition Lean Body Mass

    Time frame: Baseine and after 8 weeks

    Participants' lean body mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).

  19. Body Composition Visceral Fat

    Time frame: Baseline and after 8 weeks

    Participants' visceral fat will be measured using Bioelectrical Impedance Analysis (BIA).

  20. Basal Metabolic Rate

    Time frame: Baseline and 8 weeks

    Basal metabolic rate measurements will be taken using a portable indirect calorimeter.

  21. Peripheral Muscle Strength

    Time frame: Baseline and 8 weeks

    Peripheral muscle strength assessment will include measurements of quadriceps femoris muscle strength and hand grip strength. An electronic hand dynamometer will be used to assess quadriceps femoris muscle strength. Participants' grip strength will be measured using a Jamar brand hydraulic hand dynamometer.

  22. Physical Activity Level

    Time frame: Baseline and after 8 weeeks

    Physical activity level will be measured with a wearable activity monitor that tracks daily step count and activity minutes.

  23. Change in Quality of Life Score

    Time frame: Baseline and after 8 weeks.

    The Turkish version of the Polycystic Ovary Syndrome (PCOS) Quality of Life-50 Questionnaire (PCOSQ-50) will be used to assess quality of life. The scale's total score and subscale scores are calculated using a scale with values of never 5, rarely 4, sometimes 3, frequently 4, and always 1. The total score ranges from 50 to 250 points.

  24. Change in Menstrual Cycle Regularity

    Time frame: Baseline and after 8 weeks

    Changes in menstrual cycle regularity will be assessed at baseline and after 8 weeks using daily logs.

  25. Exercise Adherence

    Time frame: Baseline and after 8 weeks

    Participants' attendance and compliance with the sessions will be directly monitored by the physiotherapist. Attendance will be determined based on the number of sessions attended, for a total of 24 sessions. Attendance is defined as attending at least 80% of the scheduled exercise sessions.

  26. Exercise Satisfaction

    Time frame: Baseline and after 8 weeks

    Participants' satisfaction level with the exercise programs will be assessed using the Global Rating of Change (GRC). Participants will be asked to express their level of satisfaction with the application using a single question. They will be asked to rate their satisfaction on a 5-point Likert scale, with "1" representing very poor satisfaction and "5" representing very good satisfaction.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

Investigation of the Effectiveness of a Digital Rehabilitation-Supported Combined Exercise Program in the Management of Polycystic Ovary Syndrome

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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