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- Ensaio Clínico NCT07757633
Pelvic Floor Muscle Training and Neuromuscular Performance in Women's Rugby
This randomized controlled trial will evaluate whether a rugby-tailored pelvic floor muscle training programme reduces urinary incontinence symptoms and influences neuromuscular performance in professional and semi-professional women rugby players. A total of 48 players aged 18 to 45 years with self-reported urinary incontinence will be randomly assigned in a 1:1 ratio to the pelvic floor muscle training group or a control group.
The intervention group will complete an individualized, remotely supervised programme integrating pelvic floor muscle contractions, breathing and postural coordination, the "Knack" technique, progressive functional exercises, and rugby-relevant movement tasks. The control group will continue usual rugby training without study pelvic floor muscle training during the intervention period.
Outcomes will be measured at baseline and immediately after the intervention. The primary outcome is change in urinary incontinence severity measured with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). Secondary outcomes include broader pelvic floor symptom screening, jump performance, maximal isometric lower-limb force, reactive strength, and programme adherence.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Urinary incontinence is common in women athletes and may affect training participation, confidence, concentration, and sporting performance. Rugby exposes athletes to repeated impacts, rapid decelerations, collisions, and high trunk and intra-abdominal pressure demands. Conventional pelvic floor muscle training may not fully reflect these sport-specific demands.
This study is a two-arm, parallel-group randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio using a computer-generated sequence prepared by an independent researcher. Allocation will be concealed using sealed, opaque envelopes.
Participants allocated to the intervention will complete a rugby-tailored pelvic floor muscle training programme delivered remotely by certified pelvic health physiotherapists and sport scientists. The programme includes education, breathing and posture coordination, pelvic floor contractions in different positions, pre-activation before high-impact tasks ("the Knack"), progressive functional strength and landing tasks, technique correction, and individualized progression. Participants will continue their usual rugby training. Control participants will continue usual rugby training and will not complete the study exercise programme during the intervention period. After post-intervention assessment, control participants will be offered the programme materials and a remote advisory session.
Assessments will combine self-reported pelvic floor outcomes with force-plate measures. The ICIQ-UI SF and Pelvic Floor Dysfunction Screening Tool (PFD-SENTINEL) will be completed at baseline and post-intervention. Neuromuscular testing will include countermovement jumps, an isometric strength test, and a reactive jump assessment. Adherence will be monitored using participant records, physiotherapist logs, and remote-session attendance. The principal analysis will compare changes over time between groups using a mixed-effects model or equivalent repeated-measures approach, with sensitivity analyses adjusted for baseline outcome values and relevant participant and training characteristics.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Javier Courel-Ibáñez, PhD
- Número de telefone: +34952 69 87 00
- E-mail: courel@ugr.es
Locais de estudo
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Granada, Espanha, 18071
- Recrutamento
- Faculty of Sport Sciences, University of Granada
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Contato:
- Javier Courel-Ibáñez, PhD
- Número de telefone: +34952 69 87 00
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Female rugby player aged 18 to 45 years.
- Competing at professional or semi-professional level.
- Currently participating in an active rugby training and competition schedule.
- Self-reported urinary leakage during the previous four weeks, an ICIQ-UI SF total score ≥3, and reported leakage during physical activity/exercise, coughing or sneezing on the self-diagnostic item.
- Able to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Pregnant at the time of enrolment.
- Childbirth within the previous 12 months.
- Previous pelvic surgery.
- Significant musculoskeletal injury during the previous 6 months, defined as any injury that prevented full participation in rugby training or competition for ≥7 consecutive days, or that could compromise the safe completion of study assessments.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Rugby-Tailored Pelvic Floor Muscle Training Programme
Participants will continue usual rugby training and complete the remotely supervised rugby-tailored pelvic floor muscle training programme.
The intervention includes pelvic floor and deep abdominal muscle coordination, breathing and posture exercises, progressive contractions in different positions, the "Knack" before impact-related tasks, functional strength and landing exercises, individualized progression, and remote technique feedback.
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The intervention is an individualized, remotely delivered pelvic floor training programme designed for women rugby players. It combines: (1) pelvic floor muscle awareness, activation, and complete relaxation; (2) coordination with the transversus abdominis, breathing, and posture; (3) progressive pelvic floor contractions in lying, quadruped, standing, and dynamic positions; (4) the "Knack," involving pelvic floor pre-activation before impact or high-pressure tasks; (5) progressive rugby-relevant functional tasks such as squatting, jumping, landing, and repeated impact preparation; and (6) individualized feedback from certified pelvic health physiotherapists. Dose: 8 weeks, with 3 sessions per week. Adherence is monitored using participant self-reports, physiotherapist records, and remote-session attendance. |
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Sem intervenção: Control
Participants will continue their usual rugby training and will not complete the study pelvic floor muscle exercise programme during the intervention period.
After post-intervention assessment, they will be offered access to the programme materials and one remote advisory session with a pelvic health physiotherapist.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) total score
Prazo: Baseline and immediately after the intervention (8 weeks)
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Urinary incontinence symptom severity will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF).
The questionnaire contains three scored items assessing urinary-leakage frequency, amount of leakage and interference with everyday life.
The total score ranges from 0 to 21 points, with higher scores indicating greater urinary incontinence severity and impact and therefore a worse outcome.
Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement.
The primary endpoint will be the between-group difference in change from baseline to 8 weeks.
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Baseline and immediately after the intervention (8 weeks)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Pelvic Floor Dysfunction Screening Tool in Female Athletes (PFD-SENTINEL) symptom count
Prazo: Baseline and immediately after the intervention (8 weeks)
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Pelvic floor dysfunction symptoms will be assessed using the Pelvic Floor Dysfunction Screening Tool in Female Athletes, known as PFD-SENTINEL.
The instrument includes five binary pelvic floor symptom indicators.
A study-defined symptom count will be calculated by summing the number of symptoms reported, producing a score from 0 to 5. Higher scores indicate a greater number of pelvic floor dysfunction symptom categories and therefore a worse outcome.
A count of at least one symptom meets the PFD-SENTINEL criterion for direct referral to a pelvic floor specialist.
Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement.
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Baseline and immediately after the intervention (8 weeks)
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Change in Pelvic Floor Dysfunction Screening Tool in Female Athletes (PFD-SENTINEL) risk, clinical and sport-related item count
Prazo: Baseline and immediately after the intervention (8 weeks)
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Risk factors and clinical and sport-related characteristics will be assessed using the Pelvic Floor Dysfunction Screening Tool in Female Athletes, known as PFD-SENTINEL.
The instrument contains 28 binary risk, clinical and sport-related items.
A study-defined item count will be calculated by summing the number of items reported, producing a score from 0 to 28.
Higher scores indicate a greater number of characteristics associated with potential pelvic floor dysfunction and therefore a worse outcome.
A count of 14 or more items meets the PFD-SENTINEL criterion for direct referral to a pelvic floor specialist.
Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement.
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Baseline and immediately after the intervention (8 weeks)
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Change in countermovement jump height
Prazo: Baseline and immediately after the intervention (8 weeks)
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Countermovement jump height will be assessed using a force plate.
Participants will perform three maximal countermovement jumps with their hands maintained on their hips.
Jump height will be recorded in centimetres.
Higher values indicate greater vertical jump performance and therefore a better outcome.
The highest value obtained from the three valid trials will be used for analysis.
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Baseline and immediately after the intervention (8 weeks)
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Change in maximal isometric squat peak force
Prazo: Baseline and immediately after the intervention (8 weeks)
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Lower-body maximal isometric strength will be assessed using a force plate during three maximal isometric squat trials performed at a knee angle of approximately 110 degrees.
Peak force will be recorded in newtons.
Higher values indicate greater maximal isometric strength and therefore a better outcome.
The highest peak-force value obtained from the three valid trials will be used for analysis.
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Baseline and immediately after the intervention (8 weeks)
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Change in Reactive Strength Index during the countermovement rebound jump
Prazo: Baseline and immediately after the intervention (8 weeks)
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Reactive jump performance will be assessed using a force plate during three maximal countermovement rebound jump trials performed with the hands maintained on the hips.
Reactive Strength Index will be calculated as rebound jump height in metres divided by ground contact time in seconds and will be expressed in metres per second.
Higher values indicate greater reactive jump performance and therefore a better outcome.
The highest Reactive Strength Index obtained from the three valid trials will be used for analysis.
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Baseline and immediately after the intervention (8 weeks)
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Change in self-reported amount of urinary leakage during the countermovement jump test
Prazo: Baseline and immediately after the intervention (8 weeks)
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Immediately after completing the three countermovement jump trials, participants will report the amount of urinary leakage experienced during the test using the response categories from the amount-of-leakage item of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form.
The item is scored as 0 = no leakage, 2 = a small amount, 4 = a moderate amount, and 6 = a large amount.
Possible scores range from 0 to 6, with higher scores indicating a greater amount of urinary leakage and therefore a worse outcome.
Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement.
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Baseline and immediately after the intervention (8 weeks)
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Change in self-reported amount of urinary leakage during the isometric squat test
Prazo: Baseline and immediately after the intervention (8 weeks)
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Immediately after completing the three maximal isometric squat trials performed at a knee angle of approximately 110 degrees, participants will report the amount of urinary leakage experienced during the test using the response categories from the amount-of-leakage item of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form.
The item is scored as 0 = no leakage, 2 = a small amount, 4 = a moderate amount, and 6 = a large amount.
Possible scores range from 0 to 6, with higher scores indicating a greater amount of urinary leakage and therefore a worse outcome.
Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement.
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Baseline and immediately after the intervention (8 weeks)
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Change in self-reported amount of urinary leakage during the countermovement rebound jump test
Prazo: Baseline and immediately after the intervention (8 weeks)
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Immediately after completing the three countermovement rebound jump trials, participants will report the amount of urinary leakage experienced during the test using the response categories from the amount-of-leakage item of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form.
The item is scored as 0 = no leakage, 2 = a small amount, 4 = a moderate amount, and 6 = a large amount.
Possible scores range from 0 to 6, with higher scores indicating a greater amount of urinary leakage and therefore a worse outcome.
Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement.
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Baseline and immediately after the intervention (8 weeks)
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Adherence to the pelvic floor muscle training programme
Prazo: Adherence will be summarized as the percentage of prescribed home-training sessions completed, based on weekly participant self-reports.
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Throughout the intervention period (weeks 1-8)
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Adherence will be summarized as the percentage of prescribed home-training sessions completed, based on weekly participant self-reports.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Publicações Gerais
- Dakic J, Perraton L, Lindstrom J, Hain E, Chuah S, Stay S. The Hidden Challenge: Pelvic Floor Symptoms and Their Impact on Performance and Well-Being in Elite Female Rugby Players. Eur J Sport Sci. 2025 Aug;25(8):e70013. doi: 10.1002/ejsc.70013.
- Donnelly GM, Bo K, Forner LB, Rankin A, Moore IS. Up for the tackle? The pelvic floor and rugby. A review. Eur J Sport Sci. 2024 Dec;24(12):1719-1734. doi: 10.1002/ejsc.12121. Epub 2024 May 11.
- Dominguez-Perez N, Sevilla-Arrabal I, Navarro-Brazalez B, Torres-Lacomba M, Courel-Ibanez J. Urinary Incontinence in Women Athletes: Umbrella Review and Meta-analysis of Sport-Related Factors. Sports Med. 2026 Apr 16. doi: 10.1007/s40279-026-02438-z. Online ahead of print.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Complicações na Gravidez
- Distúrbios da micção
- Sintomas do Trato Urinário Inferior
- Manifestações Urológicas
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Incontinencia urinaria
- Incontinência Urinária, Estresse
- Distúrbios do assoalho pélvico
Outros números de identificação do estudo
- G-2504-06806
Plano para dados de participantes individuais (IPD)
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