Effects of Pilates Exercises on Doppler Parameters in Obese Females With Polycystic Ovarian Syndrome

November 8, 2026 updated by: Afaf Mohamed El-Sayed, Cairo University

The purpose of this study is to determine the effect of Pilates exercises on Doppler parameters in obese females with polycystic ovarian syndrome.

Study Overview

Status

Not yet recruiting

Detailed Description

Polycystic ovary syndrome (PCOS) is a heterogeneous endocrine disorder that impacts many women of the reproductive age worldwide. Depending on diagnostic criteria, this disorder affects ∼6% to 20% of reproductive aged women, with symptoms of PCO arise during the early pubertal years Pilates exercises are a set of specialized and combined exercises of both body and mind. Pilates lead to are markable decrease in body weight, BMI, lean body mass, and waist circumference in obese adults and this lead to decrease insulin resistance in obese PCO. Pilates exercises played an important role in improving physical fitness, body composition, metabolic disorders, and depression in women. It was reported that 30-45 min Pilates exercise could produce positive changes in energy expenditure, thus reducing body weight.

There is dearth of knowledge regarding the effect of weight loss interventions on Doppler parameters in obese PCOS females. Therefore, this study will be conducted to provide physiotherapists with a scientific updated knowledge, concerning effect of Pilates exercises on Doppler parameters in obese females with PCOS, aiming to normalize their Doppler parameters. This study may expand role of physiotherapy in woman's health.

Study Type

Interventional

Enrollment (Estimated)

40

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

      • Tanta, Egypt
        • Afaf Mohamed El-Sayed

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

25 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

All polycystic ovarian syndrome (PCOS) females will have two of the 3 features of Rotterdam criteria for the diagnosis of PCOS which include oligo or anovulation, clinical and/or biochemical signs of hyperandrogenism (i.e. hirsutism, acne, male pattern balding, elevated serum androgens), and polycystic ovaries on ultrasound.

  • Their age will range from 25 to 35 years old.
  • Their body mass index will be 30-35 kg/m2.
  • Their waist hip ratio will be > 0.85.
  • They should be non-smokers.
  • They should have sedentary life style without participation at any exercise training program during this study.

Exclusion Criteria:

  • They shouldn't have cardio respiratory, renal, neurological and pelvic inflammatory diseases, anemia, diabetes, hypertension, asthma, rheumatoid arthritis, headache, migraine, thyroid or mental disorders.
  • They shouldn't receive any medical therapy for treating PCOS or for weight reduction.
  • They shouldn't follow any exercise and/or diet program at least one month before the treatment program.
  • Cardiac pacemaker users.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mediterranean diet group

The participants will receive Mediterranean diet program, for 8 weeks.

Diet aimed to restrict the intake of sweets and foods containing trans fatty acids. The participants had a maximum carbohydrate intake of less than 20%, a maximum carbohydrate intake of 100 g throughout the day and an increased intake of protein and fat. Participants were advised to consume whole grain as a staple food, a high intake of extra virgin olive oil, vegetables (including green leafy vegetables, fruit, cereals, nuts, and legumes), moderate intake of fish and other meat, dairy products, and a low intake of eggs

Experimental: Mediterranean diet and Pilates exercise group

The participants will receive the same Mediterranean diet program, in addition to Pilates exercises, three times per week, for 8 weeks.

Diet aimed to restrict the intake of sweets and foods containing trans fatty acids. The participants had a maximum carbohydrate intake of less than 20%, a maximum carbohydrate intake of 100 g throughout the day and an increased intake of protein and fat. Participants were advised to consume whole grain as a staple food, a high intake of extra virgin olive oil, vegetables (including green leafy vegetables, fruit, cereals, nuts, and legumes), moderate intake of fish and other meat, dairy products, and a low intake of eggs

It includes 5 Pilates exercises including bridge marching exercise, single-leg circles exercise, rolling like a ball exercise, plank to pike exercise, and side kneeling circles. The exercises will be performed 3 times per week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weigh (kilograms)
Time Frame: 8 weeks

Body weight will be measured by weight scale (kilograms) for all participants before and after treatment

8 weeks
Body height (meter)
Time Frame: 8 weeks

The height will be measured by height scale in meters for all participants before and after treatment

8 weeks
Body mass index
Time Frame: 8 weeks

Weight-height scale will be used to measure body weight and height of each female in both groups before and after the end of treatment procedures to calculate body mass index.

8 weeks
Waist-hip ratio
Time Frame: 8 weeks

Tape measurement will be used to measure circumference of waist and hip for all participated females in both groups before and after the end of treatment procedures to calculate Waist-hip ratio.

8 weeks
Peak systolic velocity (PSV)
Time Frame: 8 weeks

The colour Doppler ultrasound will be used to measure peak systolic velocity (PSV). PSV reflects the extent of vascular filling and blood supply.

8 weeks
end-diastolic velocity (EDV)
Time Frame: 8 weeks

The colour Doppler ultrasound will be used to measure the end-diastolic velocity (EDV). EDV reflects the blood perfusion situation of the distal tissue and numerical drop shows shortage of distal blood supply.

8 weeks
Resistance index (RI)
Time Frame: 8 weeks

The Colour Doppler ultrasound will be used to measure the resistance index (RI). RI will be calculated as difference between Peak systolic velocity (PSV) and end-diastolic velocity (EDV) divided by Peak systolic velocity (PSV). RI reflects impedance to blood flow, and lower values of RI and PI indicate higher blood flow.

8 weeks
Pulsatility index (PI)
Time Frame: 8 weeks

The Colour Doppler ultrasound will be used to measure the Pulsatility index (PI). PI will be calculated as the difference between Peak systolic velocity (PSV) and end-diastolic velocity (EDV) divided by the mean maximum flow velocity. PI reflects impedance to blood flow, and lower values of RI and PI indicate higher blood flow.

8 weeks
Ovarian volume
Time Frame: 8 weeks

The ovarian volume will be measured by the ultrasonography. it is one of the diagnostic criteria of polycystic ovarian syndrome (more than 10 ml).

8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
36-Item Short Form Health Survey (SF-36)
Time Frame: 8 weeks

It will be used to evaluate health-related quality of life for each participants in both groups before and after the treatment course. It is a 36 item-scale which covers two categories: physical component summary and mental component summary. Each item falls on a 0-100 scale. Higher values indicate better health.

8 weeks

Collaborators and Investigators

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

Investigators

  • Study Chair: khadyga Abdul Aziz, Professor, Cairo University
  • Study Director: Hossam Hussien, Professor, Al-Azhar University

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)

November 15, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

November 8, 2026

First Submitted That Met QC Criteria

November 8, 2026

First Posted (Actual)

November 13, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 8, 2026

Last Verified

November 1, 2026

More Information

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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