- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07578714
Core Stability, Postural Balance, and Flexibility in Healthy Women: A Comparative Study Between Pilates Practitioners and Sedentary Individuals (CSBF-P)
Přehled studie
Postavení
Detailní popis
This cross-sectional comparative study involves 55 healthy female participants divided into two groups: a Pilates group (minimum 5 months of practice, twice weekly) and a sedentary control group (less than 150 minutes of physical activity per week). To ensure objectivity and high-quality data, an "Assessor Blinding" protocol will be implemented, where the investigator performing physical measurements remains unaware of the participants' group allocation.
Primary outcomes include:
- Deep muscle stabilization measured via a Pressure Biofeedback Unit (PBU) in a prone position.
- Core endurance assessed using the McGill Core Endurance Battery (Flexor, Extensor, and Side Bridge tests).
- Dynamic postural balance evaluated through the Y-Balance Test (YBT) in anterior, posteromedial, and posterolateral directions.
- Static balance measured by the Single Leg Stance Test (SLST) with eyes open and closed.
- Hamstring and lower back flexibility assessed by the Sit and Reach Test. Statistical analysis will be performed using IBM SPSS version 26.0 to compare the outcomes between the two groups.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: WALA Abbas Mohammed TAHA, PT specialist
- Telefonní číslo: +966565787745 +905384112497
- E-mail: 2433095066@stu.istinye.edu.tr
Studijní místa
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Zeytinburnu
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Istanbul, Zeytinburnu, Turecko (Türkiye), 34010
- Nábor
- Istinye University, Topkapi Campus
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Kontakt:
- WALA Abbas Mohammed TAHA PT. MSc student, PT Specialist,master's student
- Telefonní číslo: +966565787745 +905384112497
- E-mail: 2433095066@stu.istinye.edu.tr
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Kontakt:
- NALAN Soydaş. Assistant Professor,, PhD
- Telefonní číslo: +90 535 010 54 61
- E-mail: nalan.engin@istinye.edu.tr
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Vrchní vyšetřovatel:
- WALA TAHA, PT. MSc student
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Vrchní vyšetřovatel:
- Nalan Soydaş, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Healthy female volunteers aged 20-45.
- For the Pilates group: having practiced mat Pilates, reformer Pilates, or any equipment-based Pilates discipline for at least 6 months; attending regular 60-minute sessions at least twice a week with a certified instructor.
- For the control group: having a sedentary lifestyle (weekly moderate physical activity time less than 150 minutes).
- Objectively demonstrating sedentary status using the International Physical Activity Questionnaire (IPAQ); only participants in the "low physical activity" category will be included in the control group.
- Having full cognitive ability to understand, follow, and execute all physical assessment instructions.
- Willingness to voluntarily sign the informed consent form prior to the study.
Exclusion Criteria:
- History of any surgery involving the spine, pelvis, or lower extremities within the last 12 months prior to the study.
- Currently pregnant or less than 6 months postpartum.
- Diagnosed vestibular disorders or chronic clinical balance disorders.
- History of neurological disease (MS, Parkinson's, etc.) or systemic metabolic disorder (diabetes, etc.).
- Having a pain intensity greater than 2/10 on the visual analog scale (VAS) in the lower back or lower extremities.
- Professional sports history or participation in other exercise programs exceeding 3 hours per week (excluding Pilates for the Pilates group).
- Acute musculoskeletal injuries or acute illnesses that may affect energy levels on the day of evaluation.
- Concurrent participation in other intensive core strengthening programs such as "advanced yoga" that may affect results.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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Pilates Group
Healthy women who have regularly practiced Pilates exercises for at least 5 months, with a minimum of two sessions per week.
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Sedentary Group
Healthy women with a sedentary lifestyle, defined as having less than 150 minutes of physical activity per week and no regular exercise routine in the past 3 months.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Deep Muscle Stabilization Pressure Biofeedback Device - PBU
Časové okno: At the single assessment session (Day 1)
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Measurement of the transversus abdominis muscle activation using a Pressure Biofeedback Unit (PBU).isolation is confirmed by a drop in pressure of 4-10 mmHg from a 70 mmHg baseline, sustained for 10 seconds in prone position.
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At the single assessment session (Day 1)
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Core Muscle Endurance
Časové okno: At the single assessment session (Day 1)
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Measured using the McGill Core Endurance Battery, including the Trunk Flexor, Trunk Extensor, and Side Bridge tests.
Results are recorded as the duration (in seconds) the position is maintained.
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At the single assessment session (Day 1)
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Dynamic Postural Balance Y-Balance Test (YBT)
Časové okno: At the single assessment session (Day 1)
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Assessed using the Y-Balance Test (YBT).
The maximum reach distance in three directions (Anterior, Posteromedial, and Posterolateral) will be recorded in centimeters
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At the single assessment session (Day 1)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Static Postural Balance Test or Single Leg Standing Test (SLST)
Časové okno: At the single assessment session (Day 1)
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The participant should stand on their dominant leg with their hands on their hips. Conditions: The test is performed under two conditions: Eyes open and eyes closed. Measurement: The time it takes to maintain this balance without putting the foot down or moving it is measured in seconds. |
At the single assessment session (Day 1)
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Lower Back and Hamstring Flexibility
Časové okno: At the single assessment session (Day 1)
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ssessed using the Sit and Reach Test.
The reach distance is measured in centimeters using a standard test box
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At the single assessment session (Day 1)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: NALAN Soydaş, PhD, Istinye University
Publikace a užitečné odkazy
Obecné publikace
- Alshehre Y, Alkhathami K, Brizzolara K, Weber M, Wang-Price S. Reliability and Validity of the Y-balance Test in Young Adults with Chronic Low Back Pain. Int J Sports Phys Ther. 2021 Jun 1;16(3):628-635. doi: 10.26603/001c.23430.
- Fallahasady E, Rahmanloo N, Seidi F, Rajabi R, Bayattork M. The relationship between core muscle endurance and functional movement screen scores in females with lumbar hyperlordosis: a cross-sectional study. BMC Sports Sci Med Rehabil. 2022 Oct 13;14(1):182. doi: 10.1186/s13102-022-00567-2.
- De Blaiser C, Roosen P, Willems T, De Bleecker C, Vermeulen S, Danneels L, De Ridder R. The role of core stability in the development of non-contact acute lower extremity injuries in an athletic population: A prospective study. Phys Ther Sport. 2021 Jan;47:165-172. doi: 10.1016/j.ptsp.2020.11.035. Epub 2020 Nov 30.
- Wells C, Kolt GS, Bialocerkowski A. Defining Pilates exercise: a systematic review. Complement Ther Med. 2012 Aug;20(4):253-62. doi: 10.1016/j.ctim.2012.02.005. Epub 2012 Mar 13.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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