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By invitationNCT07871851ClinicalTrials.gov record

Investigation of the Effectiveness of Spinal Stabilization Exercises Added to Aerobic Exercise in Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome (PCOS)

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 45 years
Sex eligible
Female
Healthy volunteers
Not accepted
Participants
20 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
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Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Single masked
aerobic exercise group

Not reported in this registry record.

Other: Aerobic Exercise

spinal stabilization exercise group combined with aerobic exercise

Not reported in this registry record.

Other: Aerobic Exercise · Other: Spinal Stabilization Exercise

Aerobic Exercise OTHER

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 Exercise OTHER

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Fasting Blood Glucose Concentration

Time frame: At baseline and after 8 weeks of treatment

Fasting blood glucose concentration will be measured from venous blood samples after an overnight fast and reported in mg/dL.

Secondary measures

Fasting Serum Insulin Concentration

Time frame: At baseline and after 8 weeks of treatment

Fasting serum insulin concentration will be measured from venous blood samples after an overnight fast and reported in µIU/mL.

Fasting Serum Triglyceride Concentration

Time frame: At baseline and after 8 weeks of treatment

Fasting serum triglyceride concentration will be measured from venous blood samples after an overnight fast and reported in mg/dL.

Serum High-Density Lipoprotein Cholesterol Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum high-density lipoprotein cholesterol (HDL-C) concentration will be measured from venous blood samples after an overnight fast and reported in mg/dL.

Serum Low-Density Lipoprotein Cholesterol Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum low-density lipoprotein cholesterol concentration will be measured from venous blood samples after an overnight fast and reported in mg/dL.

Serum Total Cholesterol Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum total cholesterol concentration will be measured from venous blood samples after an overnight fast and reported in mg/dL.

Serum Prolactin Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum prolactin concentration will be measured from venous blood samples after an overnight fast and reported in ng/mL.

Serum Luteinizing Hormone Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum luteinizing hormone concentration will be measured from venous blood samples after an overnight fast and reported in mIU/mL.

Serum Follicle-Stimulating Hormone Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum follicle-stimulating hormone concentration will be measured from venous blood samples after an overnight fast and reported in mIU/mL.

Serum Thyroid-Stimulating Hormone Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum thyroid-stimulating hormone concentration will be measured from venous blood samples after an overnight fast and reported in µIU/mL.

Serum High-Sensitivity C-Reactive Protein Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum high-sensitivity C-reactive protein concentration will be measured from venous blood samples after an overnight fast and reported in mg/L.

Free Androgen Index

Time frame: At baseline and after 8 weeks of treatment

Free androgen index will be calculated using total testosterone and sex hormone-binding globulin concentrations and reported as a dimensionless value.

Serum Estradiol Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum estradiol concentration will be measured from venous blood samples after an overnight fast and reported in pg/mL.

Serum Sex Hormone-Binding Globulin Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum sex hormone-binding globulin concentration will be measured from venous blood samples after an overnight fast and reported in nmol/L.

Serum Anti-Müllerian Hormone Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum anti-Müllerian hormone concentration will be measured from venous blood samples after an overnight fast and reported in ng/mL.

Homeostatic Model Assessment of Insulin Resistance

Time frame: At baseline and after 8 weeks of treatment

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.

Serum Interleukin-6 Concentration

Time frame: At baseline and after 8 weeks of treatment

Serum interleukin-6 concentration will be measured from venous blood samples using an enzyme-linked immunosorbent assay and reported in pg/mL.

Serum Interleukin-10 Concentration

Time frame: At baseline and 8 weeks after treatment.

Serum interleukin-10 concentration will be measured from venous blood samples using an enzyme-linked immunosorbent assay and reported in pg/mL.

Serum Tumor Necrosis Factor-Alpha Concentration

Time frame: At baseline and 8 weeks after treatment.

Serum tumor necrosis factor-alpha concentration will be measured from venous blood samples using an enzyme-linked immunosorbent assay and reported in pg/mL.

Serum Adiponectin Concentration

Time frame: At baseline and 8 weeks after treatment.

Serum adiponectin concentration will be measured from venous blood samples using an enzyme-linked immunosorbent assay and reported in ng/mL.

Serum Irisin Concentration.

Time frame: At baseline and 8 weeks after treatment.

Serum irisin concentration will be measured from venous blood samples using an enzyme-linked immunosorbent assay and reported in ng/mL.

Waist-to-Hip Ratio

Time frame: At baseline and 8 weeks after treatment

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.

Waist-to-Height Ratio

Time frame: At baseline and 8 weeks after treatment

Waist circumference and height will be measured in meters (m). The waist-to-height ratio will be calculated by dividing waist circumference by height.

Anthropometric Measurement (Body Mass Index)

Time frame: At baseline and 8 weeks after treatment

Body mass index will be calculated as body weight in kilograms divided by height in meters squared and reported in kg/m².

Body Weight Assessed by Bioelectrical Impedance Analysis

Time frame: At baseline and 8 weeks after treatment

Body weight will be measured using a Tanita bioelectrical impedance analysis device and reported in kilograms (kg).

Body Fat Mass Assessed by Bioelectrical Impedance Analysis

Time frame: At baseline and 8 weeks after treatment

Body fat mass will be assessed using a Tanita bioelectrical impedance analysis device and reported in kilograms (kg).

Body Fat Percentage Assessed by Bioelectrical Impedance Analysis

Time frame: At baseline and 8 weeks after treatment

Body fat percentage will be assessed using a Tanita bioelectrical impedance analysis device and reported as a percentage (%).

Fat-Free Mass Assessed by Bioelectrical Impedance Analysis

Time frame: At baseline and 8 weeks after treatment

Fat-free mass will be assessed using a Tanita bioelectrical impedance analysis device and reported in kilograms (kg).

Body Muscle Percentage Assessed by Bioelectrical Impedance Analysis

Time frame: At baseline and 8 weeks after treatment

Body muscle percentage will be assessed using a Tanita bioelectrical impedance analysis device and reported as a percentage (%).

Total Body Water Assessed by Bioelectrical Impedance Analysis

Time frame: At baseline and 8 weeks after treatment

Total body water will be assessed using a Tanita bioelectrical impedance analysis device and reported in kilograms (kg).

Total Body Water Percentage Assessed by Bioelectrical Impedance Analysis

Time frame: At baseline and 8 weeks after treatment

Total body water percentage will be assessed using a Tanita bioelectrical impedance analysis device and reported as a percentage (%).

Visceral Fat Rating Assessed by Bioelectrical Impedance Analysis

Time frame: At baseline and 8 weeks after treatment

Visceral fat will be assessed using a Tanita bioelectrical impedance analysis device and reported as the visceral fat rating provided by the device.

Cardiovascular fitness (6-minute walk test)

Time frame: At baseline and 8 weeks after treatment

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).

Core muscle endurance (trunk flexor test)

Time frame: At baseline and 8 weeks after treatment

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).

Core muscle endurance (trunk extensor test)

Time frame: At baseline and 8 weeks after treatment

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).

Core muscle endurance (side bridge test)

Time frame: At baseline and after 8 weeks of treatment

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).

Core muscle strength (sit-up test)

Time frame: At baseline and after 8 weeks of treatment

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.

Core muscle strength (Modified Push-up test)

Time frame: At baseline and after 8 weeks of treatment

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.

Polycystic Ovary Syndrome Quality of Life-50 Scale

Time frame: At baseline and after 8 weeks of treatment

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.

Patient's Perception of Global Change

Time frame: After 8 weeks of treatment

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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1 locations

Inönü University Department of Obstetrics and GynecologyMalatya, Malatya, Turkey (Türkiye)Status unknown

Study team and timeline

Lead sponsor
Inonu University
Study start
Oct 1, 2026 Actual
Primary completion
Jan 20, 2027 Estimated
Study completion
Aug 20, 2027 Estimated
First posted
Oct 13, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Investigation of the Effectiveness of Spinal Stabilization Exercises Added to Aerobic Exercise in Women With Polycystic Ovary Syndrome

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026