- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
-
-
Valencia
-
Valencia, Valencia, 스페인, 46010
- Gascó Oliag, 5
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
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.
|
No intervention
|
|
Sedentary Males
Males aged 18-35 years who do not meet the World Health Organization physical activity recommendations.
|
No intervention
|
|
Sedentary Females
Females aged 18-35 years who do not meet the World Health Organization physical activity recommendations.
|
No intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Urinary incontinence severity
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Urinary incontinence-related quality of life
기간: 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
기간: 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
기간: Baseline (single study visit)
|
Vertical jump performance assessed using the My Jump 2 application.
|
Baseline (single study visit)
|
|
Physical activity level
기간: 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)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Sports_UI
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
요실금, 스트레스에 대한 임상 시험
-
Goethe UniversityLudwig-Maximilians - University of Munich완전한
No Intervention: Observational Cohort에 대한 임상 시험
-
Guangzhou Women and Children's Medical Center아직 모집하지 않음NEC - 괴사성 장염
-
Monash UniversityThe Alfred; Melbourne Sexual Health Centre모병매독중국, 호주, 남아프리카, 영국
-
IRCCS San Raffaele모집하지 않고 적극적으로
-
University of CagliariUniversity of Milano Bicocca; University of Milan; University of Cagliari, Cagliari, Italy; Università Cattolica del Sacro Cuore, Rome, Italy모병연조직 감염 | Fournier 괴저 | 괴사성 근막염 | Fournier의 괴저이탈리아
-
IRCCS San Raffaele아직 모집하지 않음
-
PeriPharm완전한