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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Sally Olmstead
- Telefonnummer: 316-641-6192
- E-post: olmstead.sally@mayo.edu
Studieorter
-
-
Minnesota
-
Rochester, Minnesota, Förenta staterna, 55905
- Rekrytering
- Mayo Clinic
-
Kontakt:
- Sally Olmstead
- Telefonnummer: 316-641-6192
- E-post: olmstead.sally@mayo.edu
-
Kontakt:
- Nicole Ron
- Telefonnummer: 505-480-4548
- E-post: nicolejron@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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-jämförare: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Preferred Cadence
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Nicole Ron, PT, DPT, Mayo Clinic
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Manliga urogenitala sjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urineringsstörningar
- Symtom i de nedre urinvägarna
- Urologiska manifestationer
- Urininkontinens
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Urininkontinens, stress
Andra studie-ID-nummer
- 26-000371
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