ConstipationNCT05321953
The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Outcome Scores In Individuals With Chronic Constipation
A study testing Standard Physical Therapy Care and Aerobic and Inspiratory Muscle Training in people with Constipation and Constipation by Outlet Obstruction, run by University of Miami at 1 site in United States.
Trial summary
The primary aim of this study will be to determine if the addition of aerobic interval and inspiratory muscle training (IMT) targeted at improving cardiopulmonary-based measures will further improve patient satisfaction scores in individuals with chronic constipation (CC) who report plateau or limited improvements in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Constipation by Outlet Obstruction, Constipation-predominant Irritable Bowel Syndrome
- What is being tested?
- Standard Physical Therapy Care and Aerobic and Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2022to 10 May 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years of age
- Complaint of chronic constipation and associated symptoms
- Confirmed pelvic floor muscle dyssynergia
- Willing and able to sign informed consent
- Ability to comply with study guidelines.
- Potential subjects must 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
- History or present cardiac condition that would exclude them from moderate intensity exercise
- Presence of an orthopedic condition with significant severity that the exercise protocol may exacerbate
- Currently receiving additional physical therapy treatment for conditions associated with pelvic floor muscle dysfunction
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- 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 or 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 Aerobic Interval and Inspiratory Muscle Training On Patient Reported Constipation Outcome Scores In Individuals With Chronic Constipation Who Plateau or Are Non- Responders to Biofeedback Therapy: A Call to Treat Beyond The Pelvic Floor
The primary aim of this study will be to determine if the addition of aerobic interval and inspiratory muscle training (IMT) targeted at improving cardiopulmonary-based measures will further improve patient satisfaction scores in individuals with chronic constipation (CC) who report plateau or limited improvements in CC after demonstrating a corrected defecation pattern using anorectal biofeedback training.
- Conditions
- Constipation, Constipation by Outlet Obstruction, Constipation-predominant Irritable Bowel Syndrome, Constipation - Functional
- Being tested
- Standard Physical Therapy Care, Aerobic and Inspiratory Muscle Training
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physical Therapy CareOther
Standard physical therapy care. Six to eight, one hour sessions over the course of 4-6 weeks. For individuals with chronic constipation that includes biofeedback therapy, breathing techniques on the toilet, manual therapy to the abdominal wall, and education on toileting posture and favorable lifestyle habits for gut health.
Aerobic and Inspiratory Muscle TrainingOther
The exercise-based 3 times per week for 8 weeks intervention will consist of aerobic interval training and inspiratory muscle training (IMT) for a total duration of 30 minutes. Aerobic-based intervals will be performed at a moderate intensity. Aerobic modes of exercise will include upper extremity ergometer, treadmill, bike, or elliptical.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Physical Therapy With No Study Intervention | Active comparator | Participants will receive 6 weeks of standard physical therapy and have reported satisfaction and respond with a numerical value of ≤3 on a chronic constipation numeric scale. Participants will receive no additional study interventions. Receives: Other: Standard Physical Therapy Care |
| Standard of Care Physical Therapy With Study Intervention | Experimental | Participants who receive 6 weeks of standard physical therapy and have reported non satisfaction and respond with a numerical value of >3 on a chronic constipation numeric scale and have been cleared of pelvic floor muscle dyssynergia. Participants will receive an additional 8 weeks of study intervention. Receives: Other: Standard Physical Therapy Care; Other: Aerobic and Inspiratory Muscle Training |
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). A total raw score can range from 0-48. 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.
Measured: Baseline, 6 weeks, 14 weeks, 26 weeks
Secondary outcomes (5)
Change In Distance by the Incremental Shuttle Walk Test (ISWT)
The Incremental Shuttle Walk Test (ISWT) is an incremental externally paced walking test and is generally used as an index of cardiorespiratory fitness. The primary outcome is the distance covered calculated from the completed number of shuttles. The ISWT distance can be used to track changes in exercise capacity over time.
Measured: Week 6, week 14
Change In estimated oxygen consumption (eVO2) by the Incremental Shuttle Walk Test (ISWT)
The Incremental Shuttle Walk Test (ISWT) is an incremental externally paced walking test and is generally used as an index of cardiorespiratory fitness. Peak estimated oxygen consumption (eVO2) can be estimated with greater accuracy than other field tests using a linear prediction equation incorporating ISWT distance.
Measured: Week 6, week 14
Change In Heart Rate Recovery (HRR)
Heart rate recovery (HRR) will be measured as the difference of the peak heart rate at the end of the first exercise session and one minute post exercise. This will be recorded through the Polar Heart Rate chest monitor.
Measured: Week 6, week 14
Change In Maximal Inspiratory Pressure (PImax)
PImax will be measured via the test of incremental respiratory endurance (TIRE) using the Pro2fit device and application.
Measured: Week 6, week 14
Change In Rand Short Form Health Survey Questionnaire (SF-36) scores
The SF-36 is a widely recognized outcome measure used to measure health status in a variety of populations. The measure consists of eight domains and each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores measure more disability and higher scores measure less disability. Scores represent the percentage of the total possible score achieved. Items in the same domain are averaged together to create 8 scale scores.
Measured: Week 6, week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start26 May 2022
- Primary completion10 May 2023
- Study completion10 May 2023
Why it stopped: Difficulty recruiting
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
- 0 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, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321953
- Sponsor's protocol ID
- 20210958
- Status last verified
- Jun 2022
- First submitted
- 1 Apr 2022
- Last updated
- 12 May 2023
- 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 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Constipation Outcome Scores In Individuals With Chronic Constipation Who Plateau or Are Non- Responders to Biofeedback Therapy: A Call to Treat Beyond The Pelvic Floor
- ClinicalTrials.gov ID
- NCT05321953
- Acronym / sponsor ID
- 20210958
- Conditions
- Constipation, Constipation by Outlet Obstruction, Constipation-predominant Irritable Bowel Syndrome, Constipation - Functional
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- American Physical Therapy Association
- Study start
- 26 May 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 11 Apr 2022 (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 the addition of aerobic interval and inspiratory muscle training (IMT) targeted at improving cardiopulmonary-based measures will further improve patient satisfaction scores in individuals with chronic constipation (CC) who report plateau or limited improvements in CC after demonstrating a corrected defecation pattern using anorectal biofeedback training.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Physical Therapy With No Study Intervention | Active comparator | Other: Standard Physical Therapy CareParticipants will receive 6 weeks of standard physical therapy and have reported satisfaction and respond with a numerical value of ≤3 on a chronic constipation numeric scale. Participants will receive no additional study interventions. |
| Standard of Care Physical Therapy With Study Intervention | Experimental | Other: Standard Physical Therapy Care, Other: Aerobic and Inspiratory Muscle TrainingParticipants who receive 6 weeks of standard physical therapy and have reported non satisfaction and respond with a numerical value of >3 on a chronic constipation numeric scale and have been cleared of pelvic floor muscle dyssynergia. Participants will receive an additional 8 weeks of study intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults >18 years of age
- Complaint of chronic constipation and associated symptoms
- Confirmed pelvic floor muscle dyssynergia
- Willing and able to sign informed consent
- Ability to comply with study guidelines.
Key exclusion criteria (9 listed)
- Rectal prolapse greater than grade 2
- Pregnancy
- Cognitive impairments
- History or present cardiac condition that would exclude them from moderate intensity exercise
- Presence of an orthopedic condition with significant severity that the exercise protocol may exacerbate
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 |
|---|---|---|
| Standard Physical Therapy CareStandard physical therapy care. Six to eight, one hour sessions over the course of 4-6 weeks. For individuals with chronic constipation that includes biofeedback therapy, breathing techniques on the toilet, manual therapy to the abdominal wall, and education on toileting posture and favorable lifestyle habits for gut health. | Other | Standard of Care Physical Therapy With No Study Intervention, Standard of Care Physical Therapy With Study Intervention |
| Aerobic and Inspiratory Muscle TrainingThe exercise-based 3 times per week for 8 weeks intervention will consist of aerobic interval training and inspiratory muscle training (IMT) for a total duration of 30 minutes. Aerobic-based intervals will be performed at a moderate intensity. Aerobic modes of exercise will include upper extremity ergometer, treadmill, bike, or elliptical. | Other | Standard of Care Physical Therapy With Study Intervention |
Primary outcome
Change In Patient Assessment of Constipation Symptoms (PAC-SYM)
Time frame: Baseline, 6 weeks, 14 weeks, 26 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). A total raw score can range from 0-48. 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.
5 secondary outcomes
Change In Distance by the Incremental Shuttle Walk Test (ISWT)
Time frame: Week 6, week 14
Change In estimated oxygen consumption (eVO2) by the Incremental Shuttle Walk Test (ISWT)
Time frame: Week 6, week 14
Change In Heart Rate Recovery (HRR)
Time frame: Week 6, week 14
Change In Maximal Inspiratory Pressure (PImax)
Time frame: Week 6, week 14
Change In Rand Short Form Health Survey Questionnaire (SF-36) scores
Time frame: Week 6, week 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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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 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 Standard Physical Therapy Care and Aerobic and Inspiratory Muscle Training in people with Constipation and Constipation by Outlet Obstruction, 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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 12 May 2023. 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 was withdrawn before enrolling participants, so there are no results.
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, 6 weeks, 14 weeks, 26 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 12 May 2023.