Fatigability of the external anal sphincter muscles using a novel strength training resistance exercise device.
Ling Mei, Krupa Patel, Navjit Lehal...
https://pubmed.ncbi.nlm.nih.gov/33596155Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06532123
Mechanisms of Improving Fecal Continence Muscles Motor Function in Health and Disease
Led by Medical College of Wisconsin · Updated on 2025-10-23
340
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how different muscles involved in controlling fecal continence respond to fatigue when exercised against resistance. The study aims to understand the fatigue characteristics of these muscles in healthy adults across various ages and sexes, and how strengthening these muscles might improve fecal incontinence and quality of life. This investigation uses advanced recording techniques and a novel device designed to apply controlled resistance to continence muscles. Participants will use a specially designed continence muscles resistance device (c-RED) which includes balloons that provide varying levels of resistance during anal and vaginal muscle contractions. The study involves repeated muscle contractions with and without this device, measuring muscle pressure and fatigue over time. For fecal incontinence patients, the study includes a 6-week exercise program with different contraction protocols aimed at strengthening specific muscles, monitored through manometry and resistance devices. During the study, participants will undergo detailed muscle function assessments using high-resolution anorectal and vaginal manometry alongside the c-RED device. They will perform specific contraction exercises while muscle pressures and fatigue are recorded. The research team will evaluate changes in muscle contractility, fecal incontinence severity, and quality of life before and after the exercise period. Safety and adherence will be monitored throughout, with total participation spanning initial assessments and up to six weeks of home exercise protocols.
CONDITIONS
Brief Title
Mechanisms of Improving Fecal Continence Muscles Motor Function
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy volunteers without past or present history of fecal incontinence
- Patients age 18 years and older with reduced anal resting and/or squeeze pressure reflecting weakness of the anal sphincters
- Ability to perform the study contractions as instructed
You will not qualify if you...
- Age less than 18 years
- Neurological disorders such as dementia or cerebrovascular diseases
- Muscle diseases including muscular dystrophy or myopathies
- Inflammatory bowel disease or celiac disease
- Neuro-muscular junction disorders like myasthenia gravis or Eaton-Lambert syndrome
- Organ prolapse, large rectocele (>2cm), or rectal intussusception
- Hip dysplasia, recent hip surgery, or immobility
- Normal anal resting and squeeze pressure
- Impaired rectal evacuation (dyssynergic defecation)
- Fecal incontinence solely due to loss of rectal sensation
- Inability to contract the external anal sphincter at all
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessment
Duration - 1 day
Participants undergo baseline studies including anal and vaginal pressures, and fatigue studies with and without the continence muscles resistance device to measure muscle function.
1 visit (in-person)
Muscle Fatigue and Function Testing
Duration - 1 day
Participants perform repeated and sustained anal and vaginal contractions with varying resistance levels using the continence muscles resistance device to characterize muscle fatigue and motor function.
1 visit (in-person)
6-Week At-Home Exercise Program
Duration - 6 weeks
Participants perform assigned Kegel-like contraction exercise protocols at home, involving repetitive short contractions against different resistance levels using the continence muscles resistance device to improve muscle function and incontinence symptoms.
Twice daily exercises at home with weekly virtual or phone meetings for training reinforcement
Post-Exercise Evaluation
Duration - 1 day
Participants return for follow-up assessments to measure anal and vaginal pressures during contractions, fecal incontinence severity, and quality of life after completing the 6-week exercise program.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53086
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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Published Research Related To This Trial
Differences in fatigability of muscles involved in fecal continence: Potential clinical ramifications.
Krupa Patel, Ling Mei, Elliot Yu...
https://pubmed.ncbi.nlm.nih.gov/34927399