ConstipationNCT05823259
The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes
A study testing Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education and Standard Physical Therapy Care in people with Constipation and Constipation - Functional, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation, Constipation - Functional, Dyssynergia
- What is being tested?
- Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education and Standard Physical Therapy Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2023to 9 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education, Standard Physical Therapy Care
- Keywords
- Pelvic floor dysfunction, Dyssynergic defecation
- Medical subject headings
- Constipation, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Telehealth Program: Respiratory Muscle Training and Patient EducationOther
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.
Standard Physical Therapy CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Physical Therapy Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, and 8 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start30 May 2023
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- American Physical Therapy Association
- Responsible party
- Principal investigator, Lawrence Cahalin, University of Miami
- Investigators
- Lawrence Cahalin, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823259
- Sponsor's protocol ID
- 20230123
- Status last verified
- Dec 2024
- First submitted
- 10 Apr 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05823259
- Acronym / sponsor ID
- 20230123
- Conditions
- Constipation, Constipation - Functional, Dyssynergia
- Keywords
- Pelvic floor dysfunction, Dyssynergic defecation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- American Physical Therapy Association
- Study start
- 30 May 2023 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient Education | Experimental | Other: Hybrid Telehealth Program: Respiratory Muscle Training and Patient EducationParticipants 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. |
| Standard of Care Physical Therapy With No Study Intervention | Active comparator | Other: Standard Physical Therapy CareA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Telehealth Program: Respiratory Muscle Training and Patient EducationA 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. | Other | Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient Education |
| Standard Physical Therapy CareA 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. | Other | Standard of Care Physical Therapy With No Study Intervention |
Primary outcome
Change In Patient Assessment of Constipation Symptoms (PAC-SYM)
Time frame: 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.
3 secondary outcomes
Change In Maximal Inspiratory Pressure (PImax)
Time frame: Baseline and 8 weeks
Change In Maximal Expiratory Pressure (PEmax)
Time frame: Baseline and 8 weeks
Change in Hospital Depression and Anxiety Scale (HADS)
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Cahalin, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education and Standard Physical Therapy Care in people with Constipation and Constipation - Functional, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change In Patient Assessment of Constipation Symptoms (PAC-SYM) (time frame: Baseline, 4 weeks, and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.