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

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05823259

Collaborator

American Physical Therapy Association (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Constipation Constipation - Functional Dyssynergia	Other: Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education Other: Standard Physical Therapy Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change In Patient Assessment of Constipation Symptoms (PAC-SYM) [Baseline, 4 weeks, and 8 weeks]
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.

Secondary Outcome Measures

Change In Maximal Inspiratory Pressure (PImax) [Baseline and 8 weeks]
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.
Change In Maximal Expiratory Pressure (PEmax) [Baseline and 8 weeks]
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.
Change in Hospital Depression and Anxiety Scale (HADS) [Baseline and 8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Coral Gables	Florida	United States	33146

Sponsors and Collaborators

University of Miami
American Physical Therapy Association

Investigators

Principal Investigator: Lawrence Cahalin, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lawrence Cahalin, Professor of Clinical, University of Miami

ClinicalTrials.gov Identifier:

NCT05823259

Other Study ID Numbers:

20230123

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lawrence Cahalin, Professor of Clinical, University of Miami

Pelvic floor dysfunction

Dyssynergic defecation

Additional relevant MeSH terms:

Ataxia

Constipation

Study Results

No Results Posted as of Apr 21, 2023