Investigation of the Effectiveness of a Digital Rehabilitation-Supported Combined Exercise Program in the Management of Polycystic Ovary Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 33
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Investigators
Buket AKINCI
Prof. Dr.
Biruni University