Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776720
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2021-02-25
Brief Title:
Ancillary Study of the Lessening Incontinence With Low-impact Activity Study
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Ancillary Study of a Randomized Controlled Trial of a Group Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 stretchingstrengthening 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 11 ratio to participate in either a 3-month yoga program N120 or a time-equivalent non-specific muscle stretching and strengthening control program N120
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 stretchingstrengthening exercise props
For this ancillary trial research the investigators are examining ancillary measures of a physical performance status bperceived 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 frequencyseverityimpact examine intervention effects on these ancillary outcomes and assess the extent to which these ancillary outcomes mediate intervention effects on incontinence frequencyseverityimpact
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 stretchingstrengthening 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 11 ratio to participate in either a 3-month yoga program N120 or a time-equivalent non-specific muscle stretching and strengthening control program N120
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 stretchingstrengthening exercise props
For this ancillary trial research the investigators are examining ancillary measures of a physical performance status bperceived 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 frequencyseverityimpact examine intervention effects on these ancillary outcomes and assess the extent to which these ancillary outcomes mediate intervention effects on incontinence frequencyseverityimpact
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK116712-01A1 | NIH | None | None |
| K24AG068601 | NIH | None | httpsreporternihgovquickSearchK24AG068601 |