Back to resultsFunctional Assessment and Muscle Evaluation Through Exercise Trial (FAME)
Primary Purpose
Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-modal rehabilitation program
Pelvic Floor Physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Incontinence, Pelvic Floor Disorder, Pelvic Floor Muscle, Strength, Disability, Aging, Atrophy, Exercise, Magnetic Resonance Imaging, Fatty Infiltration, Physical Therapy, Multi-modal Rehabilitation, Stress Urinary Incontinence, Urge Urinary Incontinence, Mixed Urinary Incontinence
Eligibility Criteria
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.
Sites / Locations
- Howard University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multi-modal rehabilitation program
Pelvic Floor Physical therapy
Arm Description
12 weeks of various exercises
12 weeks of standard pelvic floor physical therapy
Outcomes
Primary Outcome Measures
Reduction of UI episodes
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
functional assessment
muscle quality
MRI evaluation
Full Information
NCT ID
NCT03166150
First Posted
May 23, 2017
Last Updated
September 25, 2020
Sponsor
Howard University
Collaborators
National Hispanic Council on Aging (NHCOA)
1. Study Identification
Unique Protocol Identification Number
NCT03166150
Brief Title
Functional Assessment and Muscle Evaluation Through Exercise Trial
Acronym
FAME
Official Title
Urinary Incontinence, Mobility & Muscle Function in Older Women: Functional Assessment and Muscle Evaluation Through Exercise (FAME) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Howard University
Collaborators
National Hispanic Council on Aging (NHCOA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary Incontinence, Pelvic Floor Disorder, Pelvic Floor Muscle, Strength, Disability, Aging, Atrophy, Exercise, Magnetic Resonance Imaging, Fatty Infiltration, Physical Therapy, Multi-modal Rehabilitation, Stress Urinary Incontinence, Urge Urinary Incontinence, Mixed Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multi-modal rehabilitation program
Arm Type
Experimental
Arm Description
12 weeks of various exercises
Arm Title
Pelvic Floor Physical therapy
Arm Type
Active Comparator
Arm Description
12 weeks of standard pelvic floor physical therapy
Intervention Type
Other
Intervention Name(s)
Multi-modal rehabilitation program
Intervention Description
Patients will receive 12 weeks of exercises.
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Physical therapy
Intervention Description
Pelvic Floor Physical therapy
Primary Outcome Measure Information:
Title
Reduction of UI episodes
Description
The primary outcome of this study is reduction in urinary incontinence episodes after multi-modal rehabilitation program compared to standard pelvic floor physical therapy.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
muscle strength
Description
functional assessment
Time Frame
12 weeks
Title
muscle quality
Description
MRI evaluation
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana V Sanses, M.D.
Phone
2028651164
Email
tatiana.sanses@howard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sharee Pearson, BS
Phone
2028654175
Email
sharee.pearson@howard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Sanses, M.D.
Organizational Affiliation
Howard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Sanses, MD
Phone
202-865-1164
Email
tatiana.sanses@howard.edu
First Name & Middle Initial & Last Name & Degree
Sharee Pearson, BS
Phone
2028654175
12. IPD Sharing Statement
Plan to Share IPD
No
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Functional Assessment and Muscle Evaluation Through Exercise Trial
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