Functional Assessment and Muscle Evaluation Through Exercise Trial

  • STATUS
    Recruiting
  • End date
    Dec 30, 2021
  • participants needed
    56
  • sponsor
    Howard University
Updated on 25 January 2021
functional assessment
bladder diary

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.

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.

Details
Condition Urinary Incontinence
Treatment Pelvic floor physical therapy, Multi-modal rehabilitation program
Clinical Study IdentifierNCT03166150
SponsorHoward University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Women 65 years older
Symptomatic UI
Symptoms 3 months
Episodes of UI on 3-day bladder diary
Stress, urgency, and mixed UI

Exclusion Criteria

Women unable to have functional assessment and/or complete bladder diary
Impaired mental status (MMSE <25)
Post-void residual 150 ml
Non-ambulatory (wheelchair bound), unable to complete mobility assessments
Hematuria
Urinary tract infection
Continuous Incontinence
Pelvic Organ prolapse > stage 2
Fecal impaction (no BM within 1 week), severe congestive heart failure (leg swelling edema 2+), uncontrolled diabetes (positive urine glucose Dipstick test)
Women with significant neurological or musculoskeletal conditions that compromise mobility (stroke, multiple sclerosis, amyotrophic atrophic lateral sclerosis, severe rheumatoid arthritis)
Women with contraindications to undergo MRI including claustrophobia
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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