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

8 de noviembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Doaa Osman, As.professor
  • Número de teléfono: +201115792245
  • Correo electrónico: drdoaaosman@yahoo.com

Ubicaciones de estudio

      • Tanta, Egipto
        • Afaf Mohamed El-Sayed

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

25 años a 35 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Body weigh (kilograms)
Periodo de tiempo: 8 weeks

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

8 weeks
Body height (meter)
Periodo de tiempo: 8 weeks

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

8 weeks
Body mass index
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
36-Item Short Form Health Survey (SF-36)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: khadyga Abdul Aziz, Professor, Cairo University
  • Director de estudio: Hossam Hussien, Professor, Al-Azhar University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de noviembre de 2026

Finalización primaria (Estimado)

15 de abril de 2027

Finalización del estudio (Estimado)

30 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

8 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de noviembre de 2026

Publicado por primera vez (Actual)

13 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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