Effectiveness of an 8-week Independent Cadence Retraining Program on Stress Urinary Incontinence in Parous Runners.
Effectiveness of an 8-week Independent Cadence Retraining Program on Stress Urinary Incontinence in Parous Runners: A Randomized Controlled Trial.
The purpose of this research is to assess the impact of an eight-week home cadence training program on stress urinary incontinence symptoms in parous women.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Following informed consent and completion of baseline study measures, participants will complete a home running-cadence assessment using their Garmin device. Participants will receive standardized written instructions through an electronic link, with verbal or technical assistance available from the research team as needed. Investigators will compare a cadence-increase intervention with a cadence-maintenance control condition. Both groups will complete 8 weeks of their typical at home running program. This study will be conducted entirely remotely, and no in-person study visits will be required. Participants assigned to the cadence-increase group will be instructed to continue their previously planned running program while increasing their running cadence by approximately 10% above their baseline cadence. Their Garmin watch will be programmed to provide an alert when cadence falls below or above the individualized target. Participants assigned to the cadence-maintenance control group will also continue their previously planning running program. Their Garmin watch will be programmed with cadence alerts intended to support maintenance of their baseline average cadence. The active intervention period will last eight weeks. Study measures will be collected at baseline, immediately following the eight-week intervention, and at six months. Electronic questionnaires will be used to assess urinary-incontinence symptoms and other relevant pelvic-floor symptoms.
The study is designed to determine whether a low-cost, fully remote, wearable-guided modification of running cadence can reduce SUI symptoms in parous runners.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Sally Olmstead
- Número de telefone: 316-641-6192
- E-mail: olmstead.sally@mayo.edu
Locais de estudo
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Recrutamento
- Mayo Clinic
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Contato:
- Sally Olmstead
- Número de telefone: 316-641-6192
- E-mail: olmstead.sally@mayo.edu
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Contato:
- Nicole Ron
- Número de telefone: 505-480-4548
- E-mail: nicolejron@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Healthy
- Nonpregnant
- Female volunteers
- Self-reported urinary incontinence during running with history of at least one prior delivery after 32 weeks gestation and who run 6 miles/week with a preferred cadence of less than or equal to 170 steps per minute determined via personal report from current Garmin watch data.
- Participants must own their own or have access to a Garmin watch.
- Participants must read, speak, and understand English sufficiently to provide informed consent and complete study procedures and questionnaires.
Exclusion Criteria:
- Unwillingness to complete all components of the study
- Urge only urinary incontinence
- <3 months postpartum or current pregnancy
- History of prolapse repair or incontinence surgery
- Participants will also be excluded if they do not own or utilize a Garmin watch that provides cadence assessment and alarm.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Cadence increase group
Participants will log running data and set cadence alarms to increase running cadence by 10% |
Utilizing cadence alarm on a garmin device, the intervention group will attempt to increase their running cadence by 10%. |
|
Comparador de Placebo: Cadence Maintenance Arm
Participants will log their running data and set cadence alarm to maintain cadence. |
Participants will use cadence alarms to maintain preferred running cadence. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Preferred Cadence
Prazo: Baseline and 8 weeks
|
Participants will self-assess preferred running cadence using a garmin device during a 15 minute self-paced run. |
Baseline and 8 weeks
|
|
The Pelvic Floor Distress Inventory-20 (PFDI-20)
Prazo: Baseline, 8 weeks, and 6 month
|
questionnaire that assesses bowel, bladder, and pelvic symptoms and their impact on quality of life. Scores range from 0 to 300 with higher scores indicating greater pelvic floor distress and impact on quality of life. |
Baseline, 8 weeks, and 6 month
|
|
Questionnaire for Female Urinary Incontinence Diagnosis (QUID)
Prazo: Baseline, 8 weeks, and 6 months
|
6 item urinary incontinence questionnaire. A higher SUI score (range 0-15) suggests stress urinary incontinence is more likely. A higher UUI score (range 0-15) suggests urge urinary incontinence is more likely. The questionnaire is designed to help distinguish between these two main types of urinary incontinence in women. |
Baseline, 8 weeks, and 6 months
|
|
International Consultation on Incontinence Questionnaire - Urinary Incontinence (ICIQ-UI)
Prazo: Baseline, 8 weeks, and 6 months
|
The ICIQ-UI Short Form (ICIQ-UI SF) produces a single score from 0 to 21 by summing three scored items: leakage frequency, leakage amount, and impact on daily life. A higher score indicates increased severity of urinary incontinence symptoms. |
Baseline, 8 weeks, and 6 months
|
|
Global Rating of Change (GROC)
Prazo: 8 weeks and 6 months
|
Scale allowing patient to self-report perceived change of UI symptoms. This is an 11-point scale (-5 to +5) with a higher positive score indicating greater improvement in SUI symptoms and a lower negative score indicating worsening of SUI symptoms. |
8 weeks and 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nicole Ron, PT, DPT, Mayo Clinic
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Distúrbios da micção
- Sintomas do Trato Urinário Inferior
- Manifestações Urológicas
- Incontinencia urinaria
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Incontinência Urinária, Estresse
Outros números de identificação do estudo
- 26-000371
Plano para dados de participantes individuais (IPD)
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