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

NCT05823259 | Completed

• 1 other identifier: 20230123
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Constipation; Constipation - Functional; Dyssynergia

Keywords

Pelvic floor dysfunction; Dyssynergic defecation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change In Maximal Inspiratory Pressure (PImax)

  Baseline and 8 weeks

• Change In Maximal Expiratory Pressure (PEmax)

  Baseline and 8 weeks

• Change in Hospital Depression and Anxiety Scale (HADS)

  Baseline and 8 weeks

Study Arms (2)

Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient Education

EXPERIMENTAL

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

Standard of Care Physical Therapy With No Study Intervention

ACTIVE COMPARATOR

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.

Other: Standard Physical Therapy Care

Interventions

Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education OTHER

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.

Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient Education

Standard Physical Therapy Care OTHER

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.

Standard of Care Physical Therapy With No Study Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• American Physical Therapy Association: collaborator

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Constipation; Ataxia

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lawrence Cahalin, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: May 30, 2023
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)