NCT07509762

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 3, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2027

Last Updated

June 17, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 24, 2026

Last Update Submit

June 16, 2026

Conditions

Polycystic Ovarian Syndrome (PCOS)

Keywords

PCOS, Digital rehabilitation, combined exercise, DNA methylation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (26)

  • Hormonal Parameter Testosterone

    Baseline and after 8 weeks.

  • Hormonal Parameter Luteinizing Hormone

    Baseline and after 8 weeks

  • Hormonal Parameter Follicle-Stimulating Hormone

    Baseline and after 8 weeks

  • Metabolic Parameter Fasting Blood Glucose

    Baseline and after 8 weeks

  • Metabolic Parameter Insulin Level

    Baseline and after 8 weeks

  • +21 more secondary outcomes

Study Arms (3)

Face-to-face Exercise Group

EXPERIMENTAL

Participants will perform combined exercise sessions with a physiotherapist, three times per week for 8 weeks.

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.

Behavioral: Digital rehabilitation

Physical Activity Counseling Group

NO INTERVENTION

Participants will receive physical activity recommendations.

Interventions

Face-to-face exerciseBEHAVIORAL

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.

Face-to-face Exercise Group
Digital rehabilitationBEHAVIORAL

Participants will perform a combined exercise program (aerobic and resistance exercises) through a digital rehabilitation platform.

Digital Rehabilitation Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, 34015, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 26311969BACKGROUND

  • 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.

    PMID: 40505084BACKGROUND

Related Links

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Buket Akıncı, Prof. Dr.

    Biruni University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Buket Akinci, Prof. Dr.

CONTACT

+905056415692bakinci@biruni.edu.tr

Kübra Arslan, MsC

CONTACT

+905439470584kbra.arslan96@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 3, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

March 25, 2027

Last Updated

June 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations

TU(1)