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NCT04776720 · ClinicalTrials.gov registry record · NA
Ancillary Study of the Lessening Incontinence With Low-impact Activity Study
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 240
- Enrollment target
NCT04776720 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 240 participants.
The verdict
NCT04776720, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
Study Summary
The parent trial that supports this ancillary research is a randomized controlled trial to evaluate the efficacy of a group-based yoga intervention to decrease the frequency and impact of urinary incontinence in ambulatory middle-aged and older women. Women aged 45 years and older who report daily or more frequent stress-, urgency-, or mixed-type incontinence, are not already engaged in formal yoga or muscle stretching/strengthening programs, are willing to temporarily forgo other clinical treatments for incontinence, are able to walk to and use the bathroom without assistance, and meet other eligibility criteria are being recruited from multiple locations surrounding the San Francisco Bay area. Following a series of telephone- and then clinic-based screening assessments, including a voiding diary to confirm the frequency and clinical type of incontinence, eligible women are randomized in a 1:1 ratio to participate in either a 3-month yoga program (N\~120) or a time-equivalent, non-specific muscle stretching and strengthening control program (N\~120). During the 3-month intervention period, participants participate in structured intervention programs (either yoga-specific or muscle stretching-strengthening) consisting of twice weekly, 90-minute group classes led by trained instructors). They are also be instructed to practice their assigned intervention for at least an additional hour per week, with the assistance of participant manuals created by the study team and a set of home yoga or stretching/strengthening exercise props. For this ancillary trial research, the investigators are examining ancillary measures of a) physical performance status, b)perceived stress, depression, and anxiety symptoms, and c) sleep quality, duration, and continuity, already incorporated by the principal investigator into the parent trial. The investigators will examine prospective relationships between these ancillary measures and participant-reported urinary incontinence frequency/
Interventions
- BEHAVIORAL Yoga Practice Program
- BEHAVIORAL Physical Conditioning Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2018-12-19 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04776720
The ClinicalTrials.gov registry entry for NCT04776720 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Yoga Practice Program is the first listed.
NCT04776720 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04776720 about?
NCT04776720 is a clinical study titled "Ancillary Study of the Lessening Incontinence With Low-impact Activity Study". The parent trial that supports this ancillary research is a randomized controlled trial to evaluate the efficacy of a group-based yoga intervention to decrease the frequency and impact of urinary incontinence in ambulatory middle-aged and older women. Women aged 45 years and older who report daily ...
What is the current status of trial NCT04776720?
This trial is currently completed. It is a NA study. The enrollment target is 240 participants. The study started on 2018-12-19. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT04776720?
The interventions under investigation include: Yoga Practice Program (BEHAVIORAL), Physical Conditioning Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT04776720?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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