- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07848451
Physiotherapy Exercise Programme for Pelvic Floor Function in Healthy Young Women
A Physiotherapy Exercise Programme Based on Hypopressive Exercise as Adjunctive Muscle Training for the Primary Prevention of Pelvic Floor Dysfunction
This study evaluated the effects of a 12-week physiotherapy exercise programme on pelvic floor and abdominopelvic function in healthy young nulliparous women. Participants were randomly allocated to an intervention group or a control group. The intervention included supervised and home-based exercises focused on postural organization, breathing coordination, and lumbopelvic-abdominal muscle control. The control group continued their usual activities without receiving the study intervention. Pelvic floor muscle function, abdominopelvic functional responses, respiratory function, and health-related quality of life were assessed.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Female university students aged 18 to 26 years.
- Nulliparous.
- No gynecological pathology.
- No respiratory pathology.
- History of sexual intercourse.
Exclusion Criteria:
- Failure to meet any of the inclusion criteria.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Intervention Group
Participants assigned to this group completed a 12-week physiotherapy exercise programme focused on postural organization, breathing coordination, and lumbopelvic-abdominal muscle control, combining supervised sessions with home-based exercise. |
Participants completed a 12-week exercise programme combining postural organization, breathing coordination, and lumbopelvic-abdominal motor control. The programme included a 20-minute supervised session once weekly, complemented by home-based exercise. |
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Žádný zásah: Control group
Participants assigned to this group continued their usual activities and did not receive the study exercise programme during the 12-week study period. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Subumbilical Cough Test
Časové okno: Baseline and after the 12-week intervention
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Qualitative assessment of abdominal wall response during coughing. The outcome was categorized as no bulging or bulging of the abdominal wall. Bulging was defined as caudal bulging of the umbilicopubic region during the cough maneuver, indicating insufficient abdominal muscle activation. |
Baseline and after the 12-week intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pelvic Floor Muscle Strength - Modified Oxford Scale
Časové okno: Baseline and after the 12-week intervention
|
Pelvic floor muscle strength was assessed by digital vaginal palpation using the Modified Oxford Scale, scored from 0 to 5, where 0 indicates no perceptible muscle contraction and 5 indicates a strong contraction. |
Baseline and after the 12-week intervention
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Pelvic Floor Muscle Endurance
Časové okno: Baseline and after the 12-week intervention
|
Pelvic floor muscle endurance was assessed by vaginal perineometry. Participants performed three maximal pelvic floor muscle contractions, each maintained for as long as possible. Endurance was recorded as the duration of the sustained contraction, expressed in seconds. |
Baseline and after the 12-week intervention
|
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Pelvic Floor Muscle Contraction Pressure
Časové okno: Baseline and after the 12-week intervention
|
Pelvic floor muscle contraction pressure was assessed by vaginal perineometry using a pressure probe. Participants performed three maximal pelvic floor muscle contractions, and contraction pressure was recorded in cmH2O. |
Baseline and after the 12-week intervention
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Abdominal Diastasis Functional Test
Časové okno: Baseline and after the 12-week intervention
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Abdominal wall function was assessed by palpation of the linea alba in the supraumbilical and infraumbilical regions, at rest and during trunk elevation. The test evaluated the presence or absence and location of abdominal diastasis and the response of the linea alba during abdominal muscle activation. |
Baseline and after the 12-week intervention
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Transversus Abdominis Activation Test
Časové okno: Baseline and after the 12-week intervention
|
Abdominal wall response was assessed during maximal inspiration and expiration. During maximal expiration, the outcome was categorized according to whether the abdomen protruded ("pushes") or did not protrude ("does not push"), reflecting the activation response of the transversus abdominis. |
Baseline and after the 12-week intervention
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Forced Vital Capacity (FVC)
Časové okno: Baseline and after the 12-week intervention
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Forced vital capacity was assessed by forced spirometry using a DATOSPIR-120 spirometer. Three measurements were performed and the best measurement was recorded. FVC was expressed in liters. |
Baseline and after the 12-week intervention
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Forced Expiratory Volume in One Second (FEV1)
Časové okno: Baseline and after the 12-week intervention
|
Forced expiratory volume in one second was assessed by forced spirometry using a DATOSPIR-120 spirometer. Three measurements were performed and the best measurement was recorded. FEV1 was expressed in liters. |
Baseline and after the 12-week intervention
|
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Peak Expiratory Flow (PEF)
Časové okno: Baseline and after the 12-week intervention
|
Peak expiratory flow was assessed by forced spirometry using a DATOSPIR-120 spirometer. Three measurements were performed and the best measurement was recorded. PEF was expressed in liters per second (L/s). |
Baseline and after the 12-week intervention
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Health-Related Quality of Life - SF-12
Časové okno: After the 12-week intervention
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Health-related quality of life was assessed using the 12-item Short Form Health Survey (SF-12). Physical and mental health component scores were calculated, with higher scores indicating better perceived health-related quality of life. |
After the 12-week intervention
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Luís Gómez Pérez, PhD, Universidad Miguel Hernández
Publikace a užitečné odkazy
Obecné publikace
- Sirvent-Pinar MA, Iglesias-Comesaña A, Guerrero-Rubio MA, Alarcón-Alarcón D, Rodríguez-Blanco N, Pérez de Arrilucea Le Floc'h U. Development and reproducible description of a multimodal physiotherapy intervention for pelvic floor health: a methodological report. BMC Women's Health. 2026. doi:10.1186/s12905-026-04779-3.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
Další identifikační čísla studie
- DPC.LGP.01.17
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
No prospective plan for individual participant data sharing was established for this study.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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