Polycystic Ovarian Syndrome (PCOS)
Conditions
Keywords
PCOS, Digital rehabilitation, combined exercise, DNA methylation
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: 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.
Interventions
BEHAVIORALFace-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.
BEHAVIORALDigital rehabilitation
Participants will perform a combined exercise program (aerobic and resistance exercises) through a digital rehabilitation platform.
Sponsors
Biruni University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in DNA methylation levels in women with PCOS | 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
| Measure | Time frame | Description |
|---|---|---|
| Hormonal Parameter Testosterone | Baseline and after 8 weeks. | Serum levels of testosterone will be measured at baseline and after 8 weeks. |
| Hormonal Parameter Luteinizing Hormone | Baseline and after 8 weeks | Serum levels of luteinizing hormone (LH) will be measured at baseline and after 8 weeks. |
| Hormonal Parameter Follicle-Stimulating Hormone | Baseline and after 8 weeks | Serum levels of follicle-stimulating hormone (FSH) will be measured at baseline and after 8 weeks. |
| Metabolic Parameter Fasting Blood Glucose | Baseline and after 8 weeks | For the evaluation of fasting blood glucose (FPG) will be measured in all participants baseline and after 8 weeks. |
| Metabolic Parameter Insulin Level | Baseline and after 8 weeks | For the evaluation of insulin level will be measured in all participants baseline and after 8 weeks. |
| Metabolic Parameter High-Density Lipoprotein Cholesterol | 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. |
| Metabolic Parameter Low-Density Lipoprotein Cholesterol | 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. |
| Metabolic Parameter Total Cholesterol | Baseline and after 8 weeks | For the evaluation of total cholesterol will be measured in all participants baseline and after 8 weeks. |
| Metabolic Parameter Triglycerides | Baseline and after 8 weeks | For the evaluation of triglycerides will be measured in all participants baseline and after 8 weeks. |
| Metabolic Parameter C-Reactive Protein | Baseline and after 8 weeks | For the evaluation of C-reactive protein (CRP) will be measured in all participants baseline and after 8 weeks. |
| Anthropometric Measurements Waist Circumference | Baseline and after 8 weeks | Waist circumference will be measured using standardized tape. |
| Anthropometric Measurements Hip Circumference | Baseline and after 8 weeks | Hip circumference will be measured using standardized tape. |
| Body Composition Body Mass Index | Baseline and after 8 weeks | Participants' BMI will be measured using Bioelectrical Impedance Analysis (BIA). |
| Body Composition Body Fat Mass | Baseline and after 8 weeks | Participants' body fat mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA). |
| Body Composition Body Fat Percentage | Baseline and after 8 weeks | Participants' body fat percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA). |
| Body Composition Body Muscle Percentage | Baseline and after 8 weeks | Participants' body muscle percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA). |
| Body Composition Body Muscle Mass | Baseline and after 8 weeks | Participants' body muscle mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA). |
| Body Composition Lean Body Mass | Baseine and after 8 weeks | Participants' lean body mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA). |
| Body Composition Visceral Fat | Baseline and after 8 weeks | Participants' visceral fat will be measured using Bioelectrical Impedance Analysis (BIA). |
| Basal Metabolic Rate | Baseline and 8 weeks | Basal metabolic rate measurements will be taken using a portable indirect calorimeter. |
| Peripheral Muscle Strength | 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. |
| Physical Activity Level | Baseline and after 8 weeeks | Physical activity level will be measured with a wearable activity monitor that tracks daily step count and activity minutes. |
| Change in Quality of Life Score | 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. |
| Change in Menstrual Cycle Regularity | Baseline and after 8 weeks | Changes in menstrual cycle regularity will be assessed at baseline and after 8 weeks using daily logs. |
| Exercise Adherence | 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. |
| Exercise Satisfaction | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBuket Akinci, Prof. Dr.
CONTACTKübra Arslan, MsC
PRINCIPAL_INVESTIGATORBuket Akıncı, Prof. Dr.
Biruni University, Faculty of Health Sciences
Outcome results
None listed