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

2026年11月8日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Tanta、埃及
        • Afaf Mohamed El-Sayed

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 至 35年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器: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

实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Body weigh (kilograms)
大体时间:8 weeks

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

8 weeks
Body height (meter)
大体时间:8 weeks

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

8 weeks
Body mass index
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
36-Item Short Form Health Survey (SF-36)
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:khadyga Abdul Aziz, Professor、Cairo University
  • 研究主任:Hossam Hussien, Professor、Al-Azhar University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月15日

初级完成 (估计的)

2027年4月15日

研究完成 (估计的)

2027年4月30日

研究注册日期

首次提交

2026年11月8日

首先提交符合 QC 标准的

2026年11月8日

首次发布 (实际的)

2026年11月13日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月8日

最后验证

2026年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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