- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07937202
Effects of Pilates Exercises on Doppler Parameters in Obese Females With Polycystic Ovarian Syndrome
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Afaf M El-Sayed, PHD
- Phone Number: +20105348451
- Email: fofashahen23@gmail.com
Study Contact Backup
- Name: Doaa Osman, As.professor
- Phone Number: +201115792245
- Email: drdoaaosman@yahoo.com
Study Locations
-
-
-
Tanta, Egypt
- Afaf Mohamed El-Sayed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Study Chair: khadyga Abdul Aziz, Professor, Cairo University
- Study Director: Hossam Hussien, Professor, Al-Azhar University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Ovarian Cysts
- Cysts
- Polycystic Ovary Syndrome
- Therapeutics
- Physical Therapy Modalities
- Diet, Food, and Nutrition
- Physiological Phenomena
- Nutritional Physiological Phenomena
- Diet, Plant-Based
- Diet Therapy
- Nutrition Therapy
- Diet
- Diet, Mediterranean
- Exercise Movement Techniques
Other Study ID Numbers
- P.T.REC/012/005602
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.