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

Not Applicable

Completed

• Conditions: Constipation; Constipation - Functional; Dyssynergia
• Interventions: Other: Standard Physical Therapy Care

• Registration Number: NCT05823259
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-21
• Study Start: 2023-05-30
• Status Verified: 2024-12
• Primary Completion: 2024-12-09
• Study Completion: 2024-12-09
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Physical Therapy With No Study Intervention	Standard Physical Therapy Care	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Coral Gables, Florida, United States