The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes
NCT ID: NCT05823259
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2023-05-30
2024-12-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient Education
Participants will be instructed in performing a home respiratory muscle training program using a device called the Breather that trains both inspiratory and expiratory muscle strength for 8 weeks. They will also be provided patient education on proper breathing techniques to pass a bowel movement and optimal toilet posture.
Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education
A testing session will be held where subjects will undergo respiratory muscle testing using the Pro2Fit device to measure PIMax and PEmax. During this session, subjects will be instructed in a respiratory muscle training home program utilizing a provided device call the Breather. They will be instructed to perform this program consisting of breathing exercises for 2 sets of 10 repetitions, twice a day at a difficulty level of 5-7 on the Visual Analogue Scale (VAS) scale for 8 weeks. Subjects will be shown how to follow a training program every day utilizing the free companion application to the device "Breather Coach." If subjects have issues with using technology, they will be provided a physical log to record when they complete sessions. Ten to fifteen-minute Zoom sessions with the study coordinator will be held once a week to check in on how the program is progressing, compliance, and if the resistance can be increased.
Standard of Care Physical Therapy With No Study Intervention
A historical control group of participants who received about 8 weeks of standard physical therapy care that includes interventions such as biofeedback treatment, manual therapy, therapeutic exercise, and education on improving bowel health.
Standard Physical Therapy Care
A group of patients who receive standard physical therapy care for chronic constipation at the University of Miami that consists of biofeedback therapy, manual therapy, therapeutic exercise, and patient education.
Interventions
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Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education
A testing session will be held where subjects will undergo respiratory muscle testing using the Pro2Fit device to measure PIMax and PEmax. During this session, subjects will be instructed in a respiratory muscle training home program utilizing a provided device call the Breather. They will be instructed to perform this program consisting of breathing exercises for 2 sets of 10 repetitions, twice a day at a difficulty level of 5-7 on the Visual Analogue Scale (VAS) scale for 8 weeks. Subjects will be shown how to follow a training program every day utilizing the free companion application to the device "Breather Coach." If subjects have issues with using technology, they will be provided a physical log to record when they complete sessions. Ten to fifteen-minute Zoom sessions with the study coordinator will be held once a week to check in on how the program is progressing, compliance, and if the resistance can be increased.
Standard Physical Therapy Care
A group of patients who receive standard physical therapy care for chronic constipation at the University of Miami that consists of biofeedback therapy, manual therapy, therapeutic exercise, and patient education.
Eligibility Criteria
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Inclusion Criteria
* Complaint of CC and associated symptoms
* Willing and able to sign an informed consent
* The ability to comply with study guidelines
* Report two or more of the following: straining during more than 25% of defecations, lumpy or hard stools more than 25% of defecations, sensations of incomplete bowel evacuation more than 25% of defecations, manual maneuvers to facilitate more than 25% of defecations, sensation of anorectal obstruction/blockage more than 25% of defecations, and fewer than 3 small bowel movements per week.
Exclusion Criteria
* Pregnancy
* Cognitive impairments
* Currently receiving physical therapy treatment for conditions associated with 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
* Recent unexplained weight loss \>10lbs within one month.
18 Years
ALL
Yes
Sponsors
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American Physical Therapy Association
OTHER
University of Miami
OTHER
Responsible Party
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Lawrence Cahalin
Professor of Clinical
Principal Investigators
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Lawrence Cahalin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Coral Gables, Florida, United States
Countries
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Other Identifiers
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20230123
Identifier Type: -
Identifier Source: org_study_id