Exercise Programs in Women With PCOS

N/ANot Yet RecruitingNCT07509762

Biruni University33 enrolled

Overview

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: 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline and after 8 week

Secondary Outcomes

Hormonal Parameter Testosterone

Serum levels of testosterone will be measured at baseline and after 8 weeks.

Time frame: Baseline and after 8 weeks.

Hormonal Parameter Luteinizing Hormone

Serum levels of luteinizing hormone (LH) will be measured at baseline and after 8 weeks.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and after 8 weeks

Metabolic Parameter Triglycerides

For the evaluation of triglycerides will be measured in all participants baseline and after 8 weeks.

Time frame: 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.

Time frame: Baseline and after 8 weeks

Anthropometric Measurements Waist Circumference

Waist circumference will be measured using standardized tape.

Time frame: Baseline and after 8 weeks

Anthropometric Measurements Hip Circumference

Hip circumference will be measured using standardized tape.

Time frame: Baseline and after 8 weeks

Body Composition Body Mass Index

Participants' BMI will be measured using Bioelectrical Impedance Analysis (BIA).

Time frame: Baseline and after 8 weeks

Body Composition Body Fat Mass

Participants' body fat mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).

Time frame: Baseline and after 8 weeks

Body Composition Body Fat Percentage

Participants' body fat percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA).

Time frame: Baseline and after 8 weeks

Body Composition Body Muscle Percentage

Participants' body muscle percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA).

Time frame: Baseline and after 8 weeks

Body Composition Body Muscle Mass

Participants' body muscle mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).

Time frame: Baseline and after 8 weeks

Body Composition Lean Body Mass

Participants' lean body mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).

Time frame: Baseine and after 8 weeks

Body Composition Visceral Fat

Participants' visceral fat will be measured using Bioelectrical Impedance Analysis (BIA).

Time frame: Baseline and after 8 weeks

Basal Metabolic Rate

Basal metabolic rate measurements will be taken using a portable indirect calorimeter.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and after 8 weeks

Exercise Programs in Women With PCOS

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts