Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-25 @ 7:39 AM
Study NCT ID:
NCT03166150
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Assessment and Muscle Evaluation Through Exercise Trial
Sponsor:
Howard University
Organization:
Study Overview
Official Title:
Urinary Incontinence, Mobility & Muscle Function in Older Women: Functional Assessment and Muscle Evaluation Through Exercise (FAME) Trial
Status:
COMPLETED
Status Verified Date:
2020-09
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:
FAME
Brief Summary:
The purpose of this study is to decrease rates of urinary incontinence in older women by building strength in the pelvic and lower body muscle through exercise and rehabilitation.
Detailed Description:
This study will provide data on benefits of combination the multimodal strengthening and aerobic conditioning rehabilitation program with pelvic floor muscle training and will help to characterize changes in pelvic floor and lower extremity muscles in older women with urinary incontinence.
The study focuses on a patient-centered approach to improve overall physical function in older women. The study will evaluate the incremental benefit of endurance and lower extremity muscle strengthening in addition to benefits from pelvic floor muscle training. We anticipate that this approach will decrease rates of urinary incontinence because the proposed intervention will focus on prevention of functional decline through endurance, strength, and balance training among older women.
The study will evaluate the pathophysiology of urinary incontinence in older women through evaluation of pelvic floor and lower extremities muscles with an innovative MRI protocol.
The study focuses on a patient-centered approach to improve overall physical function in older women. The study will evaluate the incremental benefit of endurance and lower extremity muscle strengthening in addition to benefits from pelvic floor muscle training. We anticipate that this approach will decrease rates of urinary incontinence because the proposed intervention will focus on prevention of functional decline through endurance, strength, and balance training among older women.
The study will evaluate the pathophysiology of urinary incontinence in older women through evaluation of pelvic floor and lower extremities muscles with an innovative MRI protocol.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: