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

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).

Study Overview

• Status: Recruiting
• Conditions: Constipation; Dyssynergia; Constipation - Functional
• Intervention / Treatment: Other: Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education; Other: Standard Physical Therapy Care

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lawrence Cahalin, PhD; Phone Number: 3052844535; Email: l.cahalin@miami.edu
• Study Contact Backup: Name: Andrea Wood, DPT; Phone Number: 2012945887; Email: ACW11@miami.edu

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • University of Miami
      • Contact: Andrea Wood, DPT; Phone Number: 305-284-2351; Email: ACW11@miami.edu
      • Principal Investigator: Lawrence Cahalin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Standard of Care Physical Therapy With No Study Intervention; Participants will receive 8 weeks of standard physical therapy care that includes interventions such as biofeedback treatment, manual therapy, therapeutic exercise, and education on improving bowel health.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change In Patient Assessment of Constipation Symptoms (PAC-SYM)	The PAC-SYM questionnaire is a 12 item questionnaire that consists of three subscales: abdominal, rectal, and stool. Each item is scored 0-4 (0: Absent, 1: Mild, 2: Moderate, 3: Severe, 4: Very Severe). The final score is the average of the summed score divided by the number of items, ranging from 0: Absent, 1: Mild, 2: Moderate, 3: Severe, 4: Very Severe. A total raw score can range for 0-48, however the average score is used to indicate the level of constipation from 0-4 with a higher number indicating higher severity of constipation.	Baseline, 4 weeks, and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change In Maximal Inspiratory Pressure (PImax)	PImax will be measured via the test of incremental respiratory endurance (TIRE) using the Pro2fit device and application. Values will be presented in cmH20. Minimal score will be a 0 with a higher value indicating greater inspiratory muscle strength.	Baseline and 8 weeks
Change In Maximal Expiratory Pressure (PEmax)	PEmax will be measured via the test of incremental respiratory endurance (TIRE) using the Pro2fit device and application. Minimal score will be a 0 with a higher value indicating greater expiratory muscle strength.	Baseline and 8 weeks
Change in Hospital Depression and Anxiety Scale (HADS)	Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with two subscales, each consisting of 7 items. For both subscales, scores between 8-10 indicate mild depression or anxiety, and scores in the range of 11-21 are indicative of depression or anxiety disorder. A cutoff score for both the anxiety and depression subscale of the HADS of ≥ 8 has been suggested as optimal in identifying depression and anxiety in individuals with irritable bowel syndrome (IBS), a disorder of gut-brain interaction.	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: American Physical Therapy Association
• Investigators: Principal Investigator: Lawrence Cahalin, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Pelvic floor dysfunction; Dyssynergic defecation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms, Digestive; Dyskinesias; Constipation; Ataxia
• Other Study ID Numbers: 20230123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No