NCT05823259

The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes

The Impact of a Widely Accessible Respiratory Muscle Training Program Integrated with Patient Education Utilizing a Hybrid Telehealth Platform on Patient-Reported Constipation Outcome Scores: a Call to Treat Beyond the Pelvic Floor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary aim of this study will be to determine if a respiratory muscle training program that includes both inspiratory muscle training (IMT) and expiratory muscle training (EMT), targeted at improving respiratory muscle performance-based measures combined with patient education about breathing on the toilet will improve patient satisfaction scores in individuals with chronic constipation (CC).

Conditions

• Constipation
• Constipation - Functional
• Dyssynergia

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2023-05-30
• Primary completion: 2024-12-09
• Completion: 2024-12-09
• First posted: 2023-04-21
• Last updated: 2024-12-13

Locations

1 site across 1 country: United States