Back to resultsThe Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes
Primary Purpose
Constipation, Constipation - Functional, Dyssynergia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education
Standard Physical Therapy Care
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring Pelvic floor dysfunction, Dyssynergic defecation
Eligibility Criteria
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.
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient Education
Standard of Care Physical Therapy With No Study Intervention
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05823259
First Posted
April 10, 2023
Last Updated
June 8, 2023
Sponsor
University of Miami
Collaborators
American Physical Therapy Association
1. Study Identification
Unique Protocol Identification Number
NCT05823259
Brief Title
The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
American Physical Therapy Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Constipation - Functional, Dyssynergia
Keywords
Pelvic floor dysfunction, Dyssynergic defecation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient Education
Arm Type
Experimental
Arm 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.
Arm Title
Standard of Care Physical Therapy With No Study Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Physical Therapy Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change In Patient Assessment of Constipation Symptoms (PAC-SYM)
Description
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.
Time Frame
Baseline, 4 weeks, and 8 weeks
Secondary Outcome Measure Information:
Title
Change In Maximal Inspiratory Pressure (PImax)
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change In Maximal Expiratory Pressure (PEmax)
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in Hospital Depression and Anxiety Scale (HADS)
Description
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.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lawrence Cahalin, PhD
Phone
3052844535
Email
l.cahalin@miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Wood, DPT
Phone
2012945887
Email
ACW11@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Cahalin, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Wood, DPT
Phone
305-284-2351
Email
ACW11@miami.edu
First Name & Middle Initial & Last Name & Degree
Lawrence Cahalin, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes
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