Muscle and Functional Assessment in Leakage Study (M-FALS)
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|ClinicalTrials.gov Identifier: NCT03166150|
Recruitment Status : Not yet recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence in Old Age||Other: Multi-modal rehabilitation program Other: Pelvic Floor Physical therapy||Not Applicable|
This study will provide data on benefits of combination of multimodal strengthening and aerobic conditioning rehabilitation program with PFMT and will help to characterize changes pelvic floor and lower extremity muscles in older women with UI after multimodal strengthening and aerobic conditioning rehabilitation program with PFMT.
The proposed study will shift the paradigm in the evaluation and treatment of older women with UI and mobility limitations. Unlike current PFMT, an innovative multimodal strengthening and aerobic conditioning rehabilitation program combined with PFMT will focus on overall physical function using a patient-centered individual approach, evaluate and treat both UI and mobility limitations. The study will evaluate the incremental benefit of endurance and lower extremity muscle strengthening in addition to benefits from PFMT. We anticipate that this approach will enhance the benefits of PFMT because the proposed intervention will focus on prevention of functional decline through endurance, strength, and balance training among older women with UI. Thus, not only it will improve UI symptoms, but also decrease mobility limitations.
Objective evaluation of mobility and MRI muscle fat infiltration and atrophy in older women with UI will give us better understanding in pathophysiology of UI and mobility limitations in older women. Muscle fat infiltration and atrophy assessment of the pelvic floor and gluteal muscles in older women is novel and may represent a biomarker which serves as a predictor of treatment success in the evaluation and management of UI and mobility in older women.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Muscle and Functional Assessment in Leakage Study|
|Estimated Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||April 30, 2019|
Experimental: Multi-modal rehabilitation program
12 weeks of various exercises
Other: Multi-modal rehabilitation program
Patients will receive 12 weeks of exercises.
Active Comparator: Pelvic Floor Physical therapy
12 weeks of standard pelvic floor physical therapy
Other: Pelvic Floor Physical therapy
Pelvic Floor Physical therapy
- Reduction of UI episodes [ Time Frame: 12 weeks ]The primary outcome of this study is reduction in urinary incontinence episodes after multi-modal rehabilitation program compared to standard pelvic floor physical therapy.
- muscle strength [ Time Frame: 12 weeks ]functional assessment
- muscle quality [ Time Frame: 12 weeks ]MRI evaluation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166150
|Contact: Sabina Salimova, M.D.||(443)firstname.lastname@example.org|
|Principal Investigator:||Tatiana Sanses, M.D.||University of Maryland|