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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Sally Olmstead
- 电话号码:316-641-6192
- 邮箱:olmstead.sally@mayo.edu
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- 招聘中
- Mayo Clinic
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接触:
- Sally Olmstead
- 电话号码:316-641-6192
- 邮箱:olmstead.sally@mayo.edu
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接触:
- Nicole Ron
- 电话号码:505-480-4548
- 邮箱:nicolejron@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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%. |
|
安慰剂比较: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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Preferred Cadence
大体时间:Baseline and 8 weeks
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Participants will self-assess preferred running cadence using a garmin device during a 15 minute self-paced run. |
Baseline and 8 weeks
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The Pelvic Floor Distress Inventory-20 (PFDI-20)
大体时间:Baseline, 8 weeks, and 6 month
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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
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Questionnaire for Female Urinary Incontinence Diagnosis (QUID)
大体时间:Baseline, 8 weeks, and 6 months
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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
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International Consultation on Incontinence Questionnaire - Urinary Incontinence (ICIQ-UI)
大体时间:Baseline, 8 weeks, and 6 months
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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
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Global Rating of Change (GROC)
大体时间:8 weeks and 6 months
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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
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合作者和调查者
赞助
调查人员
- 首席研究员:Nicole Ron, PT, DPT、Mayo Clinic
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 26-000371
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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