- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Afaf M El-Sayed, PHD
- Telefonnummer: +20105348451
- E-post: fofashahen23@gmail.com
Studera Kontakt Backup
- Namn: Doaa Osman, As.professor
- Telefonnummer: +201115792245
- E-post: drdoaaosman@yahoo.com
Studieorter
-
-
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Tanta, Egypten
- Afaf Mohamed El-Sayed
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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 |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body weigh (kilograms)
Tidsram: 8 weeks
|
Body weight will be measured by weight scale (kilograms) for all participants before and after treatment |
8 weeks
|
|
Body height (meter)
Tidsram: 8 weeks
|
The height will be measured by height scale in meters for all participants before and after treatment |
8 weeks
|
|
Body mass index
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
36-Item Short Form Health Survey (SF-36)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: khadyga Abdul Aziz, Professor, Cairo University
- Studierektor: Hossam Hussien, Professor, Al-Azhar University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Sjukdomar i det endokrina systemet
- Neoplasmer
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Genitala sjukdomar, kvinnor
- Ovariella sjukdomar
- Adnexala sjukdomar
- Gonadal sjukdomar
- Cystor på äggstockarna
- Cystor
- Polycystiskt ovariesyndrom
- Terapeutik
- Fysioterapimetoder
- Diet, mat och näring
- Fysiologiska fenomen
- Näringsfysiologiska fenomen
- Diet, växtbaserad
- Dieterapi
- Näringsterapi
- Diet
- Diet, Medelhavet
- Träningstekniker
Andra studie-ID-nummer
- P.T.REC/012/005602
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