Functional Assessment and Muscle Evaluation Through Exercise Trial (FAME)

September 25, 2020 updated by: Tatiana Sanses, Howard University

Urinary Incontinence, Mobility & Muscle Function in Older Women: Functional Assessment and Muscle Evaluation Through Exercise (FAME) Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Recruiting
        • Howard University Hospital
        • Contact:
        • Contact:
          • Sharee Pearson, BS
          • Phone Number: 2028654175

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women ≥ 65 years older
  2. Symptomatic UI
  3. Symptoms ≥ 3 months
  4. Episodes of UI on 3-day bladder diary
  5. Stress, urgency, and mixed UI

Exclusion Criteria:

  1. Women unable to have functional assessment and/or complete bladder diary
  2. Impaired mental status (MMSE <25)
  3. Post-void residual ≥ 150 ml
  4. Non-ambulatory (wheelchair bound), unable to complete mobility assessments
  5. Hematuria
  6. Urinary tract infection
  7. Continuous Incontinence
  8. Pelvic Organ prolapse > stage 2
  9. Fecal impaction (no BM within 1 week), severe congestive heart failure (leg swelling edema 2+), uncontrolled diabetes (positive urine glucose Dipstick test)
  10. Women with significant neurological or musculoskeletal conditions that compromise mobility (stroke, multiple sclerosis, amyotrophic atrophic lateral sclerosis, severe rheumatoid arthritis)
  11. Women with contraindications to undergo MRI including claustrophobia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle strength
Time Frame: 12 weeks
functional assessment
12 weeks
muscle quality
Time Frame: 12 weeks
MRI evaluation
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Howard University

Collaborators

National Hispanic Council on Aging (NHCOA)

Investigators

  • Principal Investigator: Tatiana Sanses, M.D., Howard University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2018

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 25, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-MED-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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