Polycystic Ovary Syndrome (PCOS)NCT07871851
Investigation of the Effectiveness of Spinal Stabilization Exercises Added to Aerobic Exercise in Women With Polycystic Ovary Syndrome
A study testing Aerobic Exercise and Spinal Stabilization Exercise in people with Polycystic Ovary Syndrome (PCOS), run by Inonu University.
Trial summary
Polycystic ovary syndrome (PCOS) is a multisystemic disorder with metabolic and endocrine implications, commonly observed in women of reproductive age and characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Aerobic Exercise and Spinal Stabilization Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 20 Aug 2027
- Phase
- Interventional
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals aged 18-45 years (premenopausal) diagnosed with PCOS by an obstetrician-gynecologist, with a body mass index between 25 and 39.9 kg/m² and a physical activity level below 600 MET-min/week (inactive) according to the International Physical Activity Questionnaire-Short Form (IPAQ-SF) assessment.
Who cannot join
- Pregnancy, diabetes, smoking, participation in a dietary intervention, congenital adrenal hyperplasia, thyroid diseases, hyperprolactinemia, Cushing's syndrome, or musculoskeletal disorders preventing exercise; use of antihypertensive medications, insulin-sensitizing drugs, nutritional supplements, or weight-loss medications
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Polycystic ovary syndrome (PCOS) is a multisystemic disorder with metabolic and endocrine implications, commonly observed in women of reproductive age and characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology. Insulin resistance, chronic low-grade inflammation, hormonal imbalances, and obesity can contribute to reduced cardiorespiratory fitness and muscular endurance, in addition to the metabolic complications associated with PCOS. Furthermore, psychosocial effects such as depression, anxiety, and impaired quality of life may also occur. Lifestyle modifications and exercise are among the first-line approaches in the management of PCOS. Aerobic and resistance exercises have been reported to have positive effects on insulin resistance, cardiometabolic risk factors, hormonal profiles, inflammation, body composition, and reproductive functions. However, evidence regarding the specific effects of different exercise modalities on physical fitness components-such as cardiovascular and muscular endurance, which are adversely affected in PCOS-remains limited. Spinal stabilization exercises constitute an exercise approach aimed at enhancing core muscle strength and endurance, postural control, and movement quality by targeting deep trunk muscle activation, lumbopelvic stability, and neuromuscular control. Although studies exist regarding Pilates interventions targeting the core region in individuals with PCOS, no study has been found that examines the effects of spinal stabilization exercises administered either in isolation or as an adjunct to aerobic exercise. Therefore, it is hypothesized that incorporating spinal stabilization exercises into an aerobic exercise regimen may provide additional benefits-particularly regarding metabolic, hormonal, and inflammatory outcomes, alongside physical fitness components.
The aim of this study is to comparatively examine the effects of spinal stabilization exercises added to aerobic exercise-versus aerobic exercise alone-on metabolic, hormonal, and inflammatory markers, anthropometric characteristics, cardiovascular fitness, core muscle strength and endurance, and quality of life in individuals with PCOS.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a common multisystem endocrine and metabolic disorder among women of reproductive age, characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology. In addition to reproductive disturbances, PCOS is associated with insulin resistance, chronic low-grade inflammation, hormonal imbalances, obesity, and an increased risk of long-term metabolic complications. These alterations may also negatively affect physical fitness, particularly cardiorespiratory fitness and muscular endurance. Furthermore, PCOS may be accompanied by psychosocial problems, including depression and anxiety, which may contribute to impaired quality of life.
Lifestyle interventions, particularly physical activity and exercise, are considered first-line strategies in the management of PCOS. Aerobic and resistance exercise have been shown to improve insulin resistance, cardiometabolic risk factors, hormonal profiles, inflammation, body composition, and reproductive outcomes. However, evidence regarding their effects on physical fitness components that may be impaired in PCOS, particularly cardiorespiratory fitness and muscular endurance, remains limited. Moreover, there is no clear consensus regarding the specific effectiveness of different exercise modalities, contents, and training volumes on physical fitness outcomes in women with PCOS.
Spinal stabilization exercises focus on activating the deep trunk muscles and improving lumbopelvic stability, neuromuscular control, core muscle strength and endurance, postural control, and movement quality. Considering the adverse effects of insulin resistance, chronic inflammation, and hormonal disturbances on muscle morphology and physical fitness in PCOS, spinal stabilization exercises may provide additional benefits in this population. Although Pilates-based interventions targeting the core region have demonstrated beneficial effects on quality of life, hormonal profiles, menstrual symptoms, and certain physical fitness parameters in women with PCOS, the effects of spinal stabilization exercises, either alone or in combination with aerobic exercise, have not yet been investigated in this population. Therefore, adding spinal stabilization exercises to aerobic exercise may provide additional benefits for metabolic and hormonal functions, body composition, cardiorespiratory fitness, and muscular endurance.
The aim of this study is to compare the effects of aerobic exercise combined with spinal stabilization exercises versus aerobic exercise alone on metabolic, hormonal, and inflammatory markers, anthropometric parameters, cardiorespiratory fitness, core muscle strength, core muscle endurance, and quality of life in individuals with PCOS.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- Aerobic Exercise, Spinal Stabilization Exercise
- Keywords
- Polycystic ovary syndrome, Aerobic exercise, Physical fitness, Inflammation, Quality of life
- Medical subject headings
- Polycystic Ovary Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
The aerobic training group will undergo aerobic exercise on a treadmill three days a week for eight weeks under the supervision of a specialist physiotherapist. For patients with no prior treadmill experience, the first session will serve as a trial session to facilitate adaptation to the treadmill. In subsequent sessions, the aerobic training will be conducted in phases comprising warm-up, exertion, and cool-down periods.
Spinal Stabilization ExerciseOther
As a first step in spinal stabilization training, individuals will be instructed on proper postural alignment. To determine each individual's ideal posture, a neutral spine position-characterized by comfort and a lack of pain in the lumbopelvic region-will be identified in front of a mirror, and the contraction of deep muscles (abdominal bracing) will be taught. Individuals will be required to maintain proper posture and deep muscle group activation throughout the exercises. Stretching and mobility exercises targeting the lumbar region, trunk muscles, and lower extremities will be performed for approximately 5-10 minutes as part of the warm-up and cool-down periods surrounding the spinal stabilization exercises. The exercises will be conducted for approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise group | Active comparator | Not described Receives: Other: Aerobic Exercise |
| spinal stabilization exercise group combined with aerobic exercise | Experimental | Not described Receives: Other: Aerobic Exercise; Other: Spinal Stabilization Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose Concentration
Fasting blood glucose concentration will be measured from venous blood samples after an overnight fast and reported in mg/dL.
Measured: At baseline and after 8 weeks of treatment
Secondary outcomes (39)
Fasting Serum Insulin Concentration
Fasting serum insulin concentration will be measured from venous blood samples after an overnight fast and reported in µIU/mL.
Measured: At baseline and after 8 weeks of treatment
Fasting Serum Triglyceride Concentration
Fasting serum triglyceride concentration will be measured from venous blood samples after an overnight fast and reported in mg/dL.
Measured: At baseline and after 8 weeks of treatment
Serum High-Density Lipoprotein Cholesterol Concentration
Serum high-density lipoprotein cholesterol (HDL-C) concentration will be measured from venous blood samples after an overnight fast and reported in mg/dL.
Measured: At baseline and after 8 weeks of treatment
Serum Low-Density Lipoprotein Cholesterol Concentration
Serum low-density lipoprotein cholesterol concentration will be measured from venous blood samples after an overnight fast and reported in mg/dL.
Measured: At baseline and after 8 weeks of treatment
Serum Total Cholesterol Concentration
Serum total cholesterol concentration will be measured from venous blood samples after an overnight fast and reported in mg/dL.
Measured: At baseline and after 8 weeks of treatment
Serum Prolactin Concentration
Serum prolactin concentration will be measured from venous blood samples after an overnight fast and reported in ng/mL.
Measured: At baseline and after 8 weeks of treatment
Serum Luteinizing Hormone Concentration
Serum luteinizing hormone concentration will be measured from venous blood samples after an overnight fast and reported in mIU/mL.
Measured: At baseline and after 8 weeks of treatment
Serum Follicle-Stimulating Hormone Concentration
Serum follicle-stimulating hormone concentration will be measured from venous blood samples after an overnight fast and reported in mIU/mL.
Measured: At baseline and after 8 weeks of treatment
Serum Thyroid-Stimulating Hormone Concentration
Serum thyroid-stimulating hormone concentration will be measured from venous blood samples after an overnight fast and reported in µIU/mL.
Measured: At baseline and after 8 weeks of treatment
Serum High-Sensitivity C-Reactive Protein Concentration
Serum high-sensitivity C-reactive protein concentration will be measured from venous blood samples after an overnight fast and reported in mg/L.
Measured: At baseline and after 8 weeks of treatment
Free Androgen Index
Free androgen index will be calculated using total testosterone and sex hormone-binding globulin concentrations and reported as a dimensionless value.
Measured: At baseline and after 8 weeks of treatment
Serum Estradiol Concentration
Serum estradiol concentration will be measured from venous blood samples after an overnight fast and reported in pg/mL.
Measured: At baseline and after 8 weeks of treatment
Serum Sex Hormone-Binding Globulin Concentration
Serum sex hormone-binding globulin concentration will be measured from venous blood samples after an overnight fast and reported in nmol/L.
Measured: At baseline and after 8 weeks of treatment
Serum Anti-Müllerian Hormone Concentration
Serum anti-Müllerian hormone concentration will be measured from venous blood samples after an overnight fast and reported in ng/mL.
Measured: At baseline and after 8 weeks of treatment
Homeostatic Model Assessment of Insulin Resistance
Insulin resistance will be calculated using fasting glucose and fasting insulin concentrations according to the Homeostatic Model Assessment of Insulin Resistance formula and reported as an index value.
Measured: At baseline and after 8 weeks of treatment
Serum Interleukin-6 Concentration
Serum interleukin-6 concentration will be measured from venous blood samples using an enzyme-linked immunosorbent assay and reported in pg/mL.
Measured: At baseline and after 8 weeks of treatment
Serum Interleukin-10 Concentration
Serum interleukin-10 concentration will be measured from venous blood samples using an enzyme-linked immunosorbent assay and reported in pg/mL.
Measured: At baseline and 8 weeks after treatment.
Serum Tumor Necrosis Factor-Alpha Concentration
Serum tumor necrosis factor-alpha concentration will be measured from venous blood samples using an enzyme-linked immunosorbent assay and reported in pg/mL.
Measured: At baseline and 8 weeks after treatment.
Serum Adiponectin Concentration
Serum adiponectin concentration will be measured from venous blood samples using an enzyme-linked immunosorbent assay and reported in ng/mL.
Measured: At baseline and 8 weeks after treatment.
Serum Irisin Concentration.
Serum irisin concentration will be measured from venous blood samples using an enzyme-linked immunosorbent assay and reported in ng/mL.
Measured: At baseline and 8 weeks after treatment.
Waist-to-Hip Ratio
Waist circumference and hip circumference will be measured in meters (m). The waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference.
Measured: At baseline and 8 weeks after treatment
Waist-to-Height Ratio
Waist circumference and height will be measured in meters (m). The waist-to-height ratio will be calculated by dividing waist circumference by height.
Measured: At baseline and 8 weeks after treatment
Anthropometric Measurement (Body Mass Index)
Body mass index will be calculated as body weight in kilograms divided by height in meters squared and reported in kg/m².
Measured: At baseline and 8 weeks after treatment
Body Weight Assessed by Bioelectrical Impedance Analysis
Body weight will be measured using a Tanita bioelectrical impedance analysis device and reported in kilograms (kg).
Measured: At baseline and 8 weeks after treatment
Body Fat Mass Assessed by Bioelectrical Impedance Analysis
Body fat mass will be assessed using a Tanita bioelectrical impedance analysis device and reported in kilograms (kg).
Measured: At baseline and 8 weeks after treatment
Body Fat Percentage Assessed by Bioelectrical Impedance Analysis
Body fat percentage will be assessed using a Tanita bioelectrical impedance analysis device and reported as a percentage (%).
Measured: At baseline and 8 weeks after treatment
Fat-Free Mass Assessed by Bioelectrical Impedance Analysis
Fat-free mass will be assessed using a Tanita bioelectrical impedance analysis device and reported in kilograms (kg).
Measured: At baseline and 8 weeks after treatment
Body Muscle Percentage Assessed by Bioelectrical Impedance Analysis
Body muscle percentage will be assessed using a Tanita bioelectrical impedance analysis device and reported as a percentage (%).
Measured: At baseline and 8 weeks after treatment
Total Body Water Assessed by Bioelectrical Impedance Analysis
Total body water will be assessed using a Tanita bioelectrical impedance analysis device and reported in kilograms (kg).
Measured: At baseline and 8 weeks after treatment
Total Body Water Percentage Assessed by Bioelectrical Impedance Analysis
Total body water percentage will be assessed using a Tanita bioelectrical impedance analysis device and reported as a percentage (%).
Measured: At baseline and 8 weeks after treatment
Visceral Fat Rating Assessed by Bioelectrical Impedance Analysis
Visceral fat will be assessed using a Tanita bioelectrical impedance analysis device and reported as the visceral fat rating provided by the device.
Measured: At baseline and 8 weeks after treatment
Cardiovascular fitness (6-minute walk test)
Cardiovascular fitness will be assessed using the 6-Minute Walk Test. Participants will be instructed to walk along a 30-meter corridor for 6 minutes at their usual walking pace. The total distance walked during 6 minutes will be recorded in meters (m).
Measured: At baseline and 8 weeks after treatment
Core muscle endurance (trunk flexor test)
Trunk flexor endurance will be assessed using the McGill Trunk Flexor Test. Participants will maintain the standardized trunk flexion position for as long as possible. The duration for which the position is maintained will be recorded in seconds (s).
Measured: At baseline and 8 weeks after treatment
Core muscle endurance (trunk extensor test)
Trunk extensor endurance will be assessed using the McGill Trunk Extensor Test. Participants will maintain the standardized horizontal trunk position for as long as possible. The duration for which the position is maintained will be recorded in seconds (s).
Measured: At baseline and 8 weeks after treatment
Core muscle endurance (side bridge test)
Lateral trunk muscle endurance will be assessed using the Side Bridge Test. Participants will maintain the standardized side bridge position for as long as possible. The duration for which the position is maintained will be recorded in seconds (s).
Measured: At baseline and after 8 weeks of treatment
Core muscle strength (sit-up test)
Core muscle strength will be assessed using the 30-second Sit-Up Test. Participants will perform as many sit-ups as possible within 30 seconds. The total number of correctly completed repetitions will be recorded.
Measured: At baseline and after 8 weeks of treatment
Core muscle strength (Modified Push-up test)
Core muscle strength will be assessed using the 30-second Modified Push-Up Test. Participants will perform as many modified push-ups as possible within 30 seconds. The total number of correctly completed repetitions will be recorded.
Measured: At baseline and after 8 weeks of treatment
Polycystic Ovary Syndrome Quality of Life-50 Scale
Quality of life will be assessed using the Polycystic Ovary Syndrome Quality of Life-50 Scale. The scale consists of 50 items across six domains: psychosocial and emotional status, fertility, sexual function, obesity and menstrual disorders, hirsutism, and coping with the disease. Each item is scored from 1 to 5, with a total score ranging from 50 to 250. Higher total scores indicate better quality of life.
Measured: At baseline and after 8 weeks of treatment
Patient's Perception of Global Change
Participants' perceived change in polycystic ovary syndrome-related symptoms compared with baseline will be assessed using the Global Perceived Improvement Scale. The scale ranges from 1 to 7: 1 = very much better, 2 = much better, 3 = slightly better, 4 = no change, 5 = slightly worse, 6 = much worse, and 7 = very much worse. Lower scores indicate greater perceived improvement, whereas higher scores indicate greater perceived worsening.
Measured: After 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Cumhuriyet University
- Responsible party
- Principal investigator, Emine Nacar, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871851
- Sponsor's protocol ID
- 2026-06/15
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No