Last updated: May 10, 2023
Sponsor: University of Miami
Overall Status: Trial Not Available
Phase
N/A
Condition
Constipation
Lactose Intolerance
Gastrointestinal Diseases And Disorders
Treatment
Aerobic and Inspiratory Muscle Training
Standard Physical Therapy Care
Clinical Study ID
NCT05321953
20210958
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adults >18 years of age
- Complaint of chronic constipation and associated symptoms
- Confirmed pelvic floor muscle dyssynergia
- Willing and able to sign informed consent
- Ability to comply with study guidelines.
- Potential subjects must report two or more of the following: straining during morethan 25% of defecations, lumpy or hard stools more than 25% of defecations, sensationsof incomplete bowel evacuation more than 25% of defecations, manual maneuvers tofacilitate more than 25% of defecations, sensation of anorectal obstruction/blockagemore than 25% of defecations, and fewer than 3 small bowel movements per week.
Exclusion
Exclusion Criteria:
- Rectal prolapse greater than grade 2
- Pregnancy
- Cognitive impairments
- History or present cardiac condition that would exclude them from moderate intensityexercise
- Presence of an orthopedic condition with significant severity that the exerciseprotocol may exacerbate
- Currently receiving additional physical therapy treatment for conditions associatedwith pelvic floor muscle dysfunction
- Recent surgery within the past 3 months without clearance from a medical doctor
- Medication usage that would interfere with their ability to exercise safely
- Individuals recovering from a confirmed eating disorder or recent unexplained weightloss >10lbs within one month.
Study Design
Treatment Group(s): 2
Primary Treatment: Aerobic and Inspiratory Muscle Training
Phase:
Study Start date:
May 26, 2022
Estimated Completion Date:
May 10, 2023
Connect with a study center
University of Miami
Coral Gables, Florida 33146
United StatesSite Not Available
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