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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Afaf M El-Sayed, PHD
- 電話番号：+20105348451
- メール：fofashahen23@gmail.com
研究連絡先のバックアップ
- 名前：Doaa Osman, As.professor
- 電話番号：+201115792245
- メール：drdoaaosman@yahoo.com
研究場所
-
-
-
Tanta、エジプト
- Afaf Mohamed El-Sayed
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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 |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body weigh (kilograms)
時間枠：8 weeks
|
Body weight will be measured by weight scale (kilograms) for all participants before and after treatment |
8 weeks
|
|
Body height (meter)
時間枠：8 weeks
|
The height will be measured by height scale in meters for all participants before and after treatment |
8 weeks
|
|
Body mass index
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
36-Item Short Form Health Survey (SF-36)
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：khadyga Abdul Aziz, Professor、Cairo University
- スタディディレクター：Hossam Hussien, Professor、Al-Azhar University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。