- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07710508
Difference in Incontinence Prevalence Between High Impact Athletes, Low Impact Athletes and Sedentary Subjects.
Difference in Incontinence Prevalence Between High Impact Athletes, Low Impact Athletes and Sedentary Subjects. A Functional Analysis.
This observational cross-sectional study aims to investigate the association between participation in high-impact sports, physical activity level, and urinary incontinence in young adults. The study will compare six groups based on sex and physical activity level: male and female high-impact sports participants, physically active males and females who do not participate in high-impact sports, and sedentary males and females.
Participants aged 18-35 years will undergo a single assessment including sociodemographic and medical information, physical activity assessment, urinary incontinence questionnaires, sport-related characteristics, psychosocial questions regarding the influence of social taboos on questionnaire responses, lower-limb muscle strength testing using a load cell, and vertical jump performance assessment.
The study aims to describe the prevalence, severity, type, and impact of urinary incontinence across different activity levels and sexes, and to explore potential associations with lower-limb strength, jump performance, and sport-related characteristics.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Urinary incontinence is a common condition that may affect both women and men and has been associated with physical activity and participation in high-impact sports. Although regular exercise provides substantial health benefits, repetitive increases in intra-abdominal pressure during high-impact activities may contribute to pelvic floor dysfunction in susceptible individuals. Most previous studies have focused on female athletes from specific sports, while evidence including both sexes and different physical activity levels remains limited.
This observational cross-sectional study will compare urinary incontinence characteristics among six population groups defined according to sex and physical activity level: male and female participants in high-impact sports, physically active males and females who do not participate in high-impact sports, and sedentary males and females.
Participants will attend a single face-to-face assessment session after providing written informed consent. During the visit, sociodemographic and clinical information, physical activity characteristics, sport-related variables, urinary incontinence questionnaires, and psychosocial questions related to social taboos and response honesty will be collected. Lower-limb muscle strength will be assessed using a load cell system, and jump performance will be evaluated using the My Jump 2 application.
The primary objective is to compare the prevalence, severity, type, and impact of urinary incontinence across the different study groups. Secondary analyses will explore the relationship between urinary incontinence and physical activity level, lower-limb muscle strength, jump performance, sport-related characteristics, and selected demographic and clinical variables.
Participants will be recruited through social media, institutional dissemination, and sports clubs using voluntary convenience and snowball sampling. All assessments will be performed by trained researchers following standardized procedures.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
-
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Valencia
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Valencia, Valencia, Španělsko, 46010
- Gascó Oliag, 5
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Adults aged 18 to 35 years.
- Male or female participants.
- Able to understand and provide written informed consent.
- Belong to one of the following groups:
Regular participation in high-impact sports (≥2 training sessions per week for at least the previous 2 years).
Physically active individuals meeting the World Health Organization recommendations (≥150 minutes/week of moderate-intensity activity, ≥75 minutes/week of vigorous-intensity activity, or an equivalent combination), without regular participation in high-impact sports.
Sedentary individuals who do not meet the World Health Organization physical activity recommendations.
Exclusion Criteria:
- Pregnancy or childbirth within the previous 12 months.
- Current or recent urinary tract infection.
- History of urogynecological disease or pelvic/urogynecological surgery.
- Body mass index (BMI) >35 kg/m².
- Inability to understand or complete the study procedures or questionnaires in Spanish or English.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Male High-Impact Sports Participants
Males aged 18-35 years who regularly participate in high-impact sports (at least twice per week for the previous two years).
|
No intervention
|
|
Female High-Impact Sports Participants
Females aged 18-35 years who regularly participate in high-impact sports (at least twice per week for the previous two years).
|
No intervention
|
|
Physically Active Males
Males aged 18-35 years who meet the World Health Organization physical activity recommendations but do not participate in high-impact sports.
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No intervention
|
|
Physically Active Females
Females aged 18-35 years who meet the World Health Organization physical activity recommendations but do not participate in high-impact sports.
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No intervention
|
|
Sedentary Males
Males aged 18-35 years who do not meet the World Health Organization physical activity recommendations.
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No intervention
|
|
Sedentary Females
Females aged 18-35 years who do not meet the World Health Organization physical activity recommendations.
|
No intervention
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Urinary incontinence severity
Časové okno: Baseline (single study visit)
|
Urinary incontinence severity assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
Higher scores indicate greater symptom severity and impact on quality of life.
The total score ranges from 0 to 21, with higher scores indicating more severe urinary incontinence symptoms and greater impact on quality of life.
|
Baseline (single study visit)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Urinary incontinence-related quality of life
Časové okno: Baseline (single study visit)
|
Quality of life associated with urinary incontinence assessed using the Incontinence Quality of Life Questionnaire (I-QOL).
The total score ranges from 0 to 100, with higher scores indicating better urinary incontinence-related quality of life.
|
Baseline (single study visit)
|
|
Lower-limb muscle strength
Časové okno: Baseline (single study visit)
|
Maximum voluntary force and mean voluntary force of hip adduction, abduction, flexion, extension, internal rotation, and external rotation measured using a load cell and ChronoJump software.
|
Baseline (single study visit)
|
|
Vertical jump performance
Časové okno: Baseline (single study visit)
|
Vertical jump performance assessed using the My Jump 2 application.
|
Baseline (single study visit)
|
|
Physical activity level
Časové okno: Baseline (single study visit)
|
Physical activity level assessed using the International Physical Activity Questionnaire (IPAQ).
Physical activity is expressed as metabolic equivalent (MET)-minutes per week and classified into low, moderate, or high physical activity levels, according to the IPAQ scoring protocol.
Higher MET-minutes per week indicate greater levels of physical activity.
|
Baseline (single study visit)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
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
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Mužská urogenitální onemocnění
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Poruchy močení
- Příznaky dolních močových cest
- Urologické projevy
- Patologické stavy, příznaky a symptomy
- Chování
- Příznaky a symptomy
- Únik moči
- Inkontinence moči, stres
- Motorická aktivita
Další identifikační čísla studie
- Sports_UI
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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