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

University of Miami

Status: Completed

Conditions: Constipation - Functional; Dyssynergia; Constipation

Treatments: Other: Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education; Other: Standard Physical Therapy Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05823259

20230123

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults >18 years of age
• 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

• Rectal prolapse greater than grade 2
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient Education

Experimental group

Description:

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.

Treatment:

Other: Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education

Standard of Care Physical Therapy With No Study Intervention

Active Comparator group

Description:

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.

Treatment:

Other: Standard Physical Therapy Care