- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07747259
Comparison of Core Stability, Body Awareness, Pelvic Health, Sleep, and Quality of Life in Physically Active Women With and Without Polyendocrine Metabolic Ovarian Syndrome
5. august 2026 oppdatert av: Ezgi Türkmen, Health Institutes of Turkey
Aim of the study was to compare physically active women with and without Polyendocrine Metabolic Ovarian Syndrome (PMOS) in terms of core stability, body awareness, pelvic health, sleep, and quality of life, and to reveal the possible effects of the presence of PMOS on these parameters despite physical activity.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
The study plans to include female participants who have been regularly practicing Pilates at least twice a week for at least three months at a designated Pilates studio.
Data on participants' socio-demographic characteristics, core stability, body awareness, pelvic floor function, sleep, and quality of life will be collected.
This research study is designed as an observational and cross-sectional evaluation study.
Studietype
Observasjonsmessig
Registrering (Antatt)
50
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ezgi Türkmen
- Telefonnummer: 0090 216 547 26 00
- E-post: turkmnezgi@gmail.com
Studiesteder
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Istanbul, Tyrkia (Türkiye)
- Rekruttering
- Haliç Üniversitesi
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Ta kontakt med:
- Ayşenur Çetinkaya
- Telefonnummer: 0090 212 924 24 44
- E-post: aysenurcetinkaya@halic.edu.tr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Participants with Polyendocrine Metabolic Ovarian Syndrome & Healthy Adults
Beskrivelse
Inclusion Criteria:
- Being a woman aged 18-40 with a diagnosis of PMOS (n=25).
- Being a healthy woman aged 18-40 (n=25).
- Having practiced Pilates regularly for at least three months, at least twice a week.
- Voluntarily agreeing to participate in the study.
Exclusion Criteria:
- Being pregnant or in the first 6 months postpartum.
- Being in menopause.
- Having any other diagnosed gynecological pathology.
- Having any significant physical limitations that would prevent the tests from being performed.
- Having any diagnosed psychological disorder that would hinder communication.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Group I
Paricipants with Polyendocrine Metabolic Ovarian Syndrome
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Group II
Healthy Adult Participants
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Forearm Plank Test
Tidsramme: Baseline
|
The purpose of this test is to measure the core stability, or endurance, of the trunk muscles.
Participants are asked to keep their body in a straight line against gravity with their forearms on the ground and their toes touching the ground, and to maintain their posture without changing position by contracting their abdominal muscles.
The time (in seconds) spent in this position is measured and recorded with a stopwatch.
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Baseline
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Side Bridge Test
Tidsramme: Baseline
|
The participant lies on their side with their elbow and forearm placed on the ground at shoulder level.
Legs and feet are placed on top of each other, forming a straight line.
The individual lifts their hips off the ground against gravity, bringing their body into a side bridge position parallel to the ground.
Both sides (right/left) are tested separately.
The time (in seconds) spent in this position is measured and recorded with a stopwatch.
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Baseline
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Body Awareness Questionnaire (BAQ)
Tidsramme: Baseline
|
BAQ is an 18-item self-report scale designed to measure how attentive the participants are to normal, non-emotional internal bodily processes.
It evaluates the sensitivity to everyday bodily cycles (like sleep and hunger), ability to detect subtle changes, and capacity to anticipate physical reactions.
Typically takes about 3 to 5 minutes.
Items are generally rated on a 1 to 7 scale, with higher total scores indicating greater perceived condence and accuracy in monitoring the physical state over time.
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Baseline
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Pelvic Floor Distress Inventory-20 (PFDI-20)
Tidsramme: Baseline
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This scale, which assesses pelvic floor-related symptoms and pelvic functionality, consists of three subscales: POPDI-6, CRADI-8, and UDI-6.
The average of the responses for each subscale is calculated and multiplied by 25 to create a standard score on a scale of 0-100 for each subscale.
The total PFDI-20 score is obtained by summing the scores of the three subscales and ranges from 0 to 300.
Higher scores indicate more symptoms and discomfort.
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Baseline
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Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: Baseline
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This scale was developed to assess sleep quality and disturbances over a one-month period.
The 18 items included in the scoring are grouped into 7 components.
Some components are represented by a single item, while others are obtained by combining several items.
Each item is rated on a scale of 0-3, and the scores of each component are added together to obtain a total score between 0-21.
A higher total score indicates poor sleep quality, while a score above 5 generally indicates poor sleep quality.
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Baseline
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WHO - Quality of Life - Brief (WHOQOL-BREF)
Tidsramme: Baseline
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The World Health Organization-developed quality of life assessment tool helps evaluate an individual's overall health status.
It consists of 26 questions, each scored on a 5-point Likert scale from 1 (very poor) to 5 (very good).
The scale covers four core areas of life: physical health, psychological health, social relationships, and environment.
It also includes two additional items that assess an individual's overall quality of life and health satisfaction.
Raw scores are converted into a total score on a scale of 0-100 using a formula.
Higher scores indicate a higher perceived quality of life.
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Baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
5. august 2026
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
1. september 2026
Datoer for studieregistrering
Først innsendt
27. juli 2026
Først innsendt som oppfylte QC-kriteriene
30. juli 2026
Først lagt ut (Faktiske)
5. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ETurkmen0426
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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