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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: Completed NA study, sponsored by University of California, San Francisco.

NCT04776720 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 240 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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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/

Primary Outcome

Assess change in successive semi-tandem, tandem, and one-legged balance stand tests, in which their ability to hold each position for up to 30 seconds. Scoring is based on the number of seconds in which the participant is able to hold the one-legged balance position, ranging from 0 to 30. If a participant cannot make it through the semi-tandem and tandem stands, the one-legged balance will not be attempted. They will receive a score of zero for the one-legged balance. Change was calculated as t

Interventions

  • BEHAVIORAL Yoga Practice Program
  • BEHAVIORAL Physical Conditioning Program

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2018-12-19
Est. Completion 2022-12-31
Phase NA

What the finished NCT04776720 record still lists

NCT04776720 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 2 interventions - of which Yoga Practice Program is the first listed.

NCT04776720 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04776720's enrollment target sits among peer trials

240 440th of 2000 higher than 1,542 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04776720, the US trial registry maintained by the National Library of Medicine. NCT04776720 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.