Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-01 @ 7:47 AM
Study NCT ID:
NCT05823259
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2023-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D001259', 'term': 'Ataxia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010353', 'term': 'Patient Education as Topic'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2023-04-10', 'studyFirstSubmitQcDate': '2023-04-10', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change In Patient Assessment of Constipation Symptoms (PAC-SYM)', 'timeFrame': 'Baseline, 4 weeks, and 8 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Change In Maximal Inspiratory Pressure (PImax)', 'timeFrame': 'Baseline and 8 weeks', '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.'}, {'measure': 'Change In Maximal Expiratory Pressure (PEmax)', 'timeFrame': 'Baseline and 8 weeks', '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.'}, {'measure': 'Change in Hospital Depression and Anxiety Scale (HADS)', 'timeFrame': 'Baseline and 8 weeks', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic floor dysfunction', 'Dyssynergic defecation'], 'conditions': ['Constipation', 'Constipation - Functional', 'Dyssynergia']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>18 years of age\n* Complaint of CC and associated symptoms\n* Willing and able to sign an informed consent\n* The ability to comply with study guidelines\n* 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.\n\nExclusion Criteria:\n\n* Rectal prolapse greater than grade 2\n* Pregnancy\n* Cognitive impairments\n* Currently receiving physical therapy treatment for conditions associated with pelvic floor muscle dysfunction\n* Recent surgery within the past 3 months without clearance from a medical doctor\n* Medication usage that would interfere with their ability to exercise safely\n* Individuals recovering from a confirmed eating disorder\n* Recent unexplained weight loss \\>10lbs within one month.'}, 'identificationModule': {'nctId': 'NCT05823259', 'briefTitle': 'The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '20230123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient Education', '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.', 'interventionNames': ['Other: Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Physical Therapy With No Study Intervention', 'description': '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.', 'interventionNames': ['Other: Standard Physical Therapy Care']}], 'interventions': [{'name': 'Hybrid Telehealth Program: Respiratory Muscle Training and Patient Education', 'type': 'OTHER', '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.', 'armGroupLabels': ['Hybrid Telehealth Inspiratory and Expiratory Muscle Training Program with Patient Education']}, {'name': 'Standard Physical Therapy Care', 'type': 'OTHER', '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.', 'armGroupLabels': ['Standard of Care Physical Therapy With No Study Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}], 'overallOfficials': [{'name': 'Lawrence Cahalin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Physical Therapy Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical', 'investigatorFullName': 'Lawrence Cahalin', 'investigatorAffiliation': 'University of Miami'}}}}