- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07578714
Core Stability, Postural Balance, and Flexibility in Healthy Women: A Comparative Study Between Pilates Practitioners and Sedentary Individuals (CSBF-P)
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: WALA Abbas Mohammed TAHA, PT specialist
- Numero di telefono: +966565787745 +905384112497
- Email: 2433095066@stu.istinye.edu.tr
Luoghi di studio
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Zeytinburnu
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Istanbul, Zeytinburnu, Turchia (Türkiye), 34010
- Reclutamento
- Istinye University, Topkapi Campus
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Contatto:
- WALA Abbas Mohammed TAHA PT. MSc student, PT Specialist,master's student
- Numero di telefono: +966565787745 +905384112497
- Email: 2433095066@stu.istinye.edu.tr
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Contatto:
- NALAN Soydaş. Assistant Professor,, PhD
- Numero di telefono: +90 535 010 54 61
- Email: nalan.engin@istinye.edu.tr
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Investigatore principale:
- WALA TAHA, PT. MSc student
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Investigatore principale:
- Nalan Soydaş, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Deep Muscle Stabilization Pressure Biofeedback Device - PBU
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Static Postural Balance Test or Single Leg Standing Test (SLST)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: NALAN Soydaş, PhD, Istinye University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026/53
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