Exercise Programs in Women With PCOS

March 29, 2026 updated by: Buket AKINCI, Biruni University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34015
        • Biruni University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Buket Akıncı, Prof. Dr.
        • Sub-Investigator:
          • Kübra Arslan
        • Sub-Investigator:
          • Volkan Turan, Prof. Dr.
        • Sub-Investigator:
          • Tuğba Elgün, PhD
        • Sub-Investigator:
          • Şafak Yiğit, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Face-to-face Exercise Group
Participants will perform combined exercise sessions with a physiotherapist, three times per week for 8 weeks.
Behavioral: 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.
Experimental: Digital Rehabilitation Group
Participants will perform a combined exercise program by digital rehabilitation tools with physiotherapist, three times per week for 8 weeks.
Behavioral: Digital rehabilitation
Participants will perform a combined exercise program (aerobic and resistance exercises) through a digital rehabilitation platform.
No Intervention: Physical Activity Counseling Group
Participants will receive physical activity recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hormonal Parameter Testosterone
Time Frame: Baseline and after 8 weeks.
Serum levels of testosterone will be measured at baseline and after 8 weeks.
Baseline and after 8 weeks.
Hormonal Parameter Luteinizing Hormone
Time Frame: Baseline and after 8 weeks
Serum levels of luteinizing hormone (LH) will be measured at baseline and after 8 weeks.
Baseline and after 8 weeks
Hormonal Parameter Follicle-Stimulating Hormone
Time Frame: Baseline and after 8 weeks
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
Time Frame: Baseline and after 8 weeks
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
Time Frame: Baseline and after 8 weeks
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
Time Frame: 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.
Baseline and after 8 weeks
Metabolic Parameter Low-Density Lipoprotein Cholesterol
Time Frame: 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.
Baseline and after 8 weeks
Metabolic Parameter Total Cholesterol
Time Frame: Baseline and after 8 weeks
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
Time Frame: Baseline and after 8 weeks
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
Time Frame: Baseline and after 8 weeks
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
Time Frame: Baseline and after 8 weeks
Waist circumference will be measured using standardized tape.
Baseline and after 8 weeks
Anthropometric Measurements Hip Circumference
Time Frame: Baseline and after 8 weeks
Hip circumference will be measured using standardized tape.
Baseline and after 8 weeks
Body Composition Body Mass Index
Time Frame: Baseline and after 8 weeks
Participants' BMI will be measured using Bioelectrical Impedance Analysis (BIA).
Baseline and after 8 weeks
Body Composition Body Fat Mass
Time Frame: Baseline and after 8 weeks
Participants' body fat mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).
Baseline and after 8 weeks
Body Composition Body Fat Percentage
Time Frame: Baseline and after 8 weeks
Participants' body fat percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA).
Baseline and after 8 weeks
Body Composition Body Muscle Percentage
Time Frame: Baseline and after 8 weeks
Participants' body muscle percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA).
Baseline and after 8 weeks
Body Composition Body Muscle Mass
Time Frame: Baseline and after 8 weeks
Participants' body muscle mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).
Baseline and after 8 weeks
Body Composition Lean Body Mass
Time Frame: Baseine and after 8 weeks
Participants' lean body mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).
Baseine and after 8 weeks
Body Composition Visceral Fat
Time Frame: Baseline and after 8 weeks
Participants' visceral fat will be measured using Bioelectrical Impedance Analysis (BIA).
Baseline and after 8 weeks
Basal Metabolic Rate
Time Frame: Baseline and 8 weeks
Basal metabolic rate measurements will be taken using a portable indirect calorimeter.
Baseline and 8 weeks
Peripheral Muscle Strength
Time Frame: 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.
Baseline and 8 weeks
Physical Activity Level
Time Frame: Baseline and after 8 weeeks
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
Time Frame: 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.
Baseline and after 8 weeks.
Change in Menstrual Cycle Regularity
Time Frame: Baseline and after 8 weeks
Changes in menstrual cycle regularity will be assessed at baseline and after 8 weeks using daily logs.
Baseline and after 8 weeks
Exercise Adherence
Time Frame: 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.
Baseline and after 8 weeks
Exercise Satisfaction
Time Frame: 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.
Baseline and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Investigators

  • Principal Investigator: Buket Akıncı, Prof. Dr., Biruni University, Faculty of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

March 25, 2027

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 29, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-KAEK-49-PCOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to privacy concerns and institutional regulations at Biruni University.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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