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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-to-face Exercise Group | Experimental | Participants will perform combined exercise sessions with a physiotherapist, three times per week for 8 weeks. |
|
| Digital Rehabilitation Group | Experimental | Participants will perform a combined exercise program by digital rehabilitation tools with physiotherapist, three times per week for 8 weeks. |
|
| Physical Activity Counseling Group | No Intervention | Participants will receive physical activity recommendations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and after 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Hormonal Parameter Testosterone | Serum levels of testosterone will be measured at baseline and after 8 weeks. | Baseline and after 8 weeks. |
| Hormonal Parameter Luteinizing Hormone | Serum levels of luteinizing hormone (LH) will be measured at baseline and after 8 weeks. |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Buket Akinci, Prof. Dr. | Contact | +905056415692 | bakinci@biruni.edu.tr | |
| Kübra Arslan, MsC | Contact | +905439470584 | kbra.arslan96@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Buket Akıncı, Prof. Dr. | Biruni University, Faculty of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biruni University | Istanbul | 34015 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26311969 | Background | 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. | |
| 40505084 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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Individual participant data (IPD) will not be shared due to privacy concerns and institutional regulations at Biruni University.
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Digital rehabilitation | Behavioral | Participants will perform a combined exercise program (aerobic and resistance exercises) through a digital rehabilitation platform. |
|
| Baseline and after 8 weeks |
| Hormonal Parameter Follicle-Stimulating Hormone | Serum levels of follicle-stimulating hormone (FSH) will be measured at baseline and after 8 weeks. | Baseline and after 8 weeks |
| Metabolic Parameter Fasting Blood Glucose | For the evaluation of fasting blood glucose (FPG) will be measured in all participants baseline and after 8 weeks. | Baseline and after 8 weeks |
| Metabolic Parameter Insulin Level | For the evaluation of insulin level will be measured in all participants baseline and after 8 weeks. | Baseline and after 8 weeks |
| Metabolic Parameter High-Density Lipoprotein Cholesterol | For the evaluation of high-density lipoprotein cholesterol (HDL-C) will be measured in all participants baseline and after 8 weeks. | Baseline and after 8 weeks |
| Metabolic Parameter Low-Density Lipoprotein Cholesterol | For the evaluation of low-density lipoprotein cholesterol (LDL-C) will be measured in all participants baseline and after 8 weeks. | Baseline and after 8 weeks |
| Metabolic Parameter Total Cholesterol | For the evaluation of total cholesterol will be measured in all participants baseline and after 8 weeks. | Baseline and after 8 weeks |
| Metabolic Parameter Triglycerides | For the evaluation of triglycerides will be measured in all participants baseline and after 8 weeks. | Baseline and after 8 weeks |
| Metabolic Parameter C-Reactive Protein | For the evaluation of C-reactive protein (CRP) will be measured in all participants baseline and after 8 weeks. | Baseline and after 8 weeks |
| Anthropometric Measurements Waist Circumference | Waist circumference will be measured using standardized tape. | Baseline and after 8 weeks |
| Anthropometric Measurements Hip Circumference | Hip circumference will be measured using standardized tape. | Baseline and after 8 weeks |
| Body Composition Body Mass Index | Participants' BMI will be measured using Bioelectrical Impedance Analysis (BIA). | Baseline and after 8 weeks |
| Body Composition Body Fat Mass | Participants' body fat mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA). | Baseline and after 8 weeks |
| Body Composition Body Fat Percentage | Participants' body fat percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA). | Baseline and after 8 weeks |
| Body Composition Body Muscle Percentage | Participants' body muscle percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA). | Baseline and after 8 weeks |
| Body Composition Body Muscle Mass | Participants' body muscle mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA). | Baseline and after 8 weeks |
| Body Composition Lean Body Mass | Participants' lean body mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA). | Baseine and after 8 weeks |
| Body Composition Visceral Fat | Participants' visceral fat will be measured using Bioelectrical Impedance Analysis (BIA). | Baseline and after 8 weeks |
| Basal Metabolic Rate | Basal metabolic rate measurements will be taken using a portable indirect calorimeter. | Baseline and 8 weeks |
| Peripheral Muscle Strength | 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. | Baseline and 8 weeks |
| Physical Activity Level | Physical activity level will be measured with a wearable activity monitor that tracks daily step count and activity minutes. | Baseline and after 8 weeeks |
| Change in Quality of Life Score | 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. | Baseline and after 8 weeks. |
| Change in Menstrual Cycle Regularity | Changes in menstrual cycle regularity will be assessed at baseline and after 8 weeks using daily logs. | Baseline and after 8 weeks |
| Exercise Adherence | 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. | Baseline and after 8 weeks |
| Exercise Satisfaction | 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. | Baseline and after 8 weeks |
| 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. |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |