- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07829692
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sally Olmstead
- Phone Number: 316-641-6192
- Email: olmstead.sally@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
-
Contact:
- Sally Olmstead
- Phone Number: 316-641-6192
- Email: olmstead.sally@mayo.edu
-
Contact:
- Nicole Ron
- Phone Number: 505-480-4548
- Email: nicolejron@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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%. |
|
Placebo Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preferred Cadence
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicole Ron, PT, DPT, Mayo Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Incontinence
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence, Stress
Other Study ID Numbers
- 26-000371
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.