- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07578714
Core Stability, Postural Balance, and Flexibility in Healthy Women: A Comparative Study Between Pilates Practitioners and Sedentary Individuals (CSBF-P)
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: WALA Abbas Mohammed TAHA, PT specialist
- Telefonnummer: +966565787745 +905384112497
- E-Mail: 2433095066@stu.istinye.edu.tr
Studienorte
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Zeytinburnu
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Istanbul, Zeytinburnu, Türkei (türkiye), 34010
- Rekrutierung
- Istinye University, Topkapi Campus
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Kontakt:
- WALA Abbas Mohammed TAHA PT. MSc student, PT Specialist,master's student
- Telefonnummer: +966565787745 +905384112497
- E-Mail: 2433095066@stu.istinye.edu.tr
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Kontakt:
- NALAN Soydaş. Assistant Professor,, PhD
- Telefonnummer: +90 535 010 54 61
- E-Mail: nalan.engin@istinye.edu.tr
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Hauptermittler:
- WALA TAHA, PT. MSc student
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Hauptermittler:
- Nalan Soydaş, PhD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Deep Muscle Stabilization Pressure Biofeedback Device - PBU
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Static Postural Balance Test or Single Leg Standing Test (SLST)
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: NALAN Soydaş, PhD, Istinye University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026/53
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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