Exercise Programs in Women With PCOS

Официальное название

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

Обзор

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.

Подробное описание

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:

1. Face-to-face exercise group 2. Digital rehabilitation group 3. 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.

Вмешательства

• Поведенческое Face-to-face exercise
  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.
• Поведенческое Digital rehabilitation
  Participants will perform a combined exercise program (aerobic and resistance exercises) through a digital rehabilitation platform.

Первичные конечные точки

• Change in DNA methylation levels in women with PCOS [Срок оценки: Baseline and after 8 week]

Вторичные конечные точки (12)

• Hormonal Parameter Testosterone [Срок оценки: Baseline and after 8 weeks.]
• Hormonal Parameter Luteinizing Hormone [Срок оценки: Baseline and after 8 weeks]
• Hormonal Parameter Follicle-Stimulating Hormone [Срок оценки: Baseline and after 8 weeks]
• Metabolic Parameter Fasting Blood Glucose [Срок оценки: Baseline and after 8 weeks]
• Metabolic Parameter Insulin Level [Срок оценки: Baseline and after 8 weeks]
• Metabolic Parameter High-Density Lipoprotein Cholesterol [Срок оценки: Baseline and after 8 weeks]
• Metabolic Parameter Low-Density Lipoprotein Cholesterol [Срок оценки: Baseline and after 8 weeks]
• Metabolic Parameter Total Cholesterol [Срок оценки: Baseline and after 8 weeks]
• Metabolic Parameter Triglycerides [Срок оценки: Baseline and after 8 weeks]
• Metabolic Parameter C-Reactive Protein [Срок оценки: Baseline and after 8 weeks]
• Anthropometric Measurements Waist Circumference [Срок оценки: Baseline and after 8 weeks]
• Anthropometric Measurements Hip Circumference [Срок оценки: Baseline and after 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Biruni University — Istanbul

Публикации

• Turan V, Mutlu EK, Solmaz U, Ekin A, Tosun O, Tosun G, Mat E, Gezer C, Malkoc M. Benefits of short-term structured exercise in non-overweight women with polycystic ovary syndrome: a prospective randomized controlled study. J Phys Ther Sci. 2015 Jul;27(7):2293-7. doi: 10.1589/jpts.27.2293. Epub 2015 Jul 22. PMID 26311969
• Wright PJ, Burts C, Harmon C, Corbett CF. Availability and Use of Digital Technology Among Women With Polycystic Ovary Syndrome: Scoping Review. JMIR Infodemiology. 2025 Jun 12;5:e68469. doi: 10.2196/68469. PMID 40505084

Идентификаторы

NCT: NCT07509762 · 2025-KAEK-49-PCOS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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