Polycystic Ovarian Syndrome (PCOS)NCT07509762
Exercise Programs in Women With PCOS
A study testing Face-to-face exercise and Digital rehabilitation in people with Polycystic Ovarian Syndrome (PCOS), run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS)
- What is being tested?
- Face-to-face exercise and Digital rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 25 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Biruni University
Istanbul, 34015
Buket Akıncı, Prof. Dr., +90 505 641 5692, bakinci@biruni.edu.tr
Kübra Arslan, +90 543 947 0584, kbra.arslan96@gmail.com
About this study
Official title: Investigation of the Effectiveness of a Digital Rehabilitation-Supported Combined Exercise Program in the Management of Polycystic Ovary Syndrome
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.
Read the 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.
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.
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Being tested
- Face-to-face exercise, Digital rehabilitation
- Keywords
- PCOS, Digital rehabilitation, combined exercise, DNA methylation
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face exerciseBehavioural
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 rehabilitationBehavioural
Participants will perform a combined exercise program (aerobic and resistance exercises) through a digital rehabilitation platform.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face Exercise Group | Experimental | Participants will perform combined exercise sessions with a physiotherapist, three times per week for 8 weeks. Receives: Behavioral: Face-to-face exercise |
| Digital Rehabilitation Group | Experimental | Participants will perform a combined exercise program by digital rehabilitation tools with physiotherapist, three times per week for 8 weeks. Receives: Behavioral: Digital rehabilitation |
| Physical Activity Counseling Group | No intervention | Participants will receive physical activity recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 8 week
Secondary outcomes (26)
Hormonal Parameter Testosterone
Serum levels of testosterone will be measured at baseline and after 8 weeks.
Measured: Baseline and after 8 weeks.
Hormonal Parameter Luteinizing Hormone
Serum levels of luteinizing hormone (LH) will be measured at baseline and after 8 weeks.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 8 weeks
Metabolic Parameter Triglycerides
For the evaluation of triglycerides will be measured in all participants baseline and after 8 weeks.
Measured: 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.
Measured: Baseline and after 8 weeks
Anthropometric Measurements Waist Circumference
Waist circumference will be measured using standardized tape.
Measured: Baseline and after 8 weeks
Anthropometric Measurements Hip Circumference
Hip circumference will be measured using standardized tape.
Measured: Baseline and after 8 weeks
Body Composition Body Mass Index
Participants' BMI will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: Baseline and after 8 weeks
Body Composition Body Fat Mass
Participants' body fat mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: Baseline and after 8 weeks
Body Composition Body Fat Percentage
Participants' body fat percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: Baseline and after 8 weeks
Body Composition Body Muscle Percentage
Participants' body muscle percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: Baseline and after 8 weeks
Body Composition Body Muscle Mass
Participants' body muscle mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: Baseline and after 8 weeks
Body Composition Lean Body Mass
Participants' lean body mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: Baseine and after 8 weeks
Body Composition Visceral Fat
Participants' visceral fat will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: Baseline and after 8 weeks
Basal Metabolic Rate
Basal metabolic rate measurements will be taken using a portable indirect calorimeter.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion25 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket Akıncı, Prof. Dr., Principal investigator, Biruni University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509762
- Sponsor's protocol ID
- 2025-KAEK-49-PCOS
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and institutional regulations at Biruni University.
Publications
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.
PubMed 26311969Wright 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.
PubMed 40505084
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of a Digital Rehabilitation-Supported Combined Exercise Program in the Management of Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07509762
- Acronym / sponsor ID
- 2025-KAEK-49-PCOS
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- PCOS, Digital rehabilitation, combined exercise, DNA methylation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 25 Mar 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face-to-face Exercise Group | Experimental | Behavioral: Face-to-face exerciseParticipants will perform combined exercise sessions with a physiotherapist, three times per week for 8 weeks. |
| Digital Rehabilitation Group | Experimental | Behavioral: Digital rehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-face exerciseParticipants 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. | Behavioural | Face-to-face Exercise Group |
| Digital rehabilitationParticipants will perform a combined exercise program (aerobic and resistance exercises) through a digital rehabilitation platform. | Behavioural | Digital Rehabilitation Group |
Primary outcome
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.
26 secondary outcomes
Hormonal Parameter Testosterone
Time frame: Baseline and after 8 weeks.
Hormonal Parameter Luteinizing Hormone
Time frame: Baseline and after 8 weeks
Hormonal Parameter Follicle-Stimulating Hormone
Time frame: Baseline and after 8 weeks
Metabolic Parameter Fasting Blood Glucose
Time frame: Baseline and after 8 weeks
Metabolic Parameter Insulin Level
Time frame: Baseline and after 8 weeks
Metabolic Parameter High-Density Lipoprotein Cholesterol
Time frame: Baseline and after 8 weeks
Metabolic Parameter Low-Density Lipoprotein Cholesterol
Time frame: Baseline and after 8 weeks
Metabolic Parameter Total Cholesterol
Time frame: Baseline and after 8 weeks
Metabolic Parameter Triglycerides
Time frame: Baseline and after 8 weeks
Metabolic Parameter C-Reactive Protein
Time frame: Baseline and after 8 weeks
Anthropometric Measurements Waist Circumference
Time frame: Baseline and after 8 weeks
Anthropometric Measurements Hip Circumference
Time frame: Baseline and after 8 weeks
Body Composition Body Mass Index
Time frame: Baseline and after 8 weeks
Body Composition Body Fat Mass
Time frame: Baseline and after 8 weeks
Body Composition Body Fat Percentage
Time frame: Baseline and after 8 weeks
Body Composition Body Muscle Percentage
Time frame: Baseline and after 8 weeks
Body Composition Body Muscle Mass
Time frame: Baseline and after 8 weeks
Body Composition Lean Body Mass
Time frame: Baseine and after 8 weeks
Body Composition Visceral Fat
Time frame: Baseline and after 8 weeks
Basal Metabolic Rate
Time frame: Baseline and 8 weeks
Peripheral Muscle Strength
Time frame: Baseline and 8 weeks
Physical Activity Level
Time frame: Baseline and after 8 weeeks
Change in Quality of Life Score
Time frame: Baseline and after 8 weeks.
Change in Menstrual Cycle Regularity
Time frame: Baseline and after 8 weeks
Exercise Adherence
Time frame: Baseline and after 8 weeks
Exercise Satisfaction
Time frame: Baseline and after 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 26311969Turan 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.
- Background: PubMed 40505084Wright 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and institutional regulations at Biruni University.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Buket Akıncı, Prof. Dr. principal investigator
Biruni University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face exercise and Digital rehabilitation in people with Polycystic Ovarian Syndrome (PCOS), run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Buket Akinci, Prof. Dr. (+905056415692, bakinci@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DNA methylation levels in women with PCOS (time frame: Baseline and after 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07509762, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.