FAME: Functional Assessment and Muscle Evaluation Through Exercise Trial

Sponsor

Howard University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03166150

Collaborator

National Hispanic Council on Aging (NHCOA) (Other)

Enrollment

Location

Arms

44.2

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Other: Multi-modal rehabilitation program Other: Pelvic Floor Physical therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 25, 2018

Anticipated Primary Completion Date :

May 31, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Reduction of UI episodes [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.

Secondary Outcome Measures

muscle strength [12 weeks]
functional assessment
muscle quality [12 weeks]
MRI evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Howard University Hospital	Washington	District of Columbia	United States	20060

Sponsors and Collaborators

Howard University
National Hispanic Council on Aging (NHCOA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Tatiana Sanses, MD FACOG FPMRS, Associate Professor, Chief, Female Pelvic Medicine & Reconstructive Surgery, Urogynecology, Howard University

ClinicalTrials.gov Identifier:

NCT03166150

Other Study ID Numbers:

18-MED-21

First Posted:

May 25, 2017

Last Update Posted:

Sep 28, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tatiana Sanses, MD FACOG FPMRS, Associate Professor, Chief, Female Pelvic Medicine & Reconstructive Surgery, Urogynecology, Howard University

Urinary Incontinence

Pelvic Floor Disorder

Magnetic Resonance Imaging

Fatty Infiltration

Physical Therapy

Multi-modal Rehabilitation