Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-02 @ 2:12 AM
Study NCT ID:
NCT04225104
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2020-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yogic Breathing and IBS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': "Members of the investigative team will be blinded to the participant's group assignment until all testing is completed."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-31', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-09', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IBS Symptoms', 'timeFrame': 'Once at baseline', 'description': 'IBS-Symptom Severity Scale will be administered.'}, {'measure': 'IBS Symptoms', 'timeFrame': 'Once at the end of week 2', 'description': 'IBS-Symptom Severity Scale will be administered.'}, {'measure': 'IBS Symptoms', 'timeFrame': 'Once at the end of week 4', 'description': 'IBS-Symptom Severity Scale will be administered.'}, {'measure': 'Autonomic function', 'timeFrame': 'Once at baseline', 'description': 'Heart rate variability will be assessed.'}, {'measure': 'Autonomic function', 'timeFrame': 'Once at the end of week 2', 'description': 'Heart rate variability will be assessed.'}, {'measure': 'Autonomic function', 'timeFrame': 'Once at the end of week 4', 'description': 'Heart rate variability will be assessed.'}, {'measure': 'Autonomic function', 'timeFrame': 'Once at baseline', 'description': 'Exercise heart rate recovery will be measured.'}, {'measure': 'Autonomic function', 'timeFrame': 'Once at the end of week 2', 'description': 'Exercise heart rate recovery will be measured.'}, {'measure': 'Autonomic function', 'timeFrame': 'Once at the end of week 4', 'description': 'Exercise heart rate recovery will be measured.'}, {'measure': 'Microvascular function', 'timeFrame': 'Once at baseline', 'description': 'Laser Doppler flowmetry at baseline and in response to local heating will be measured.'}, {'measure': 'Microvascular function', 'timeFrame': 'Once at the end of week 4', 'description': 'Laser Doppler flowmetry and in response to local heating will be measured.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IBS - Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '34595801', 'type': 'DERIVED', 'citation': 'Katherine Jurek M, Seavey H, Guidry M, Slomka E, Hunter SD. The effects of slow deep breathing on microvascular and autonomic function and symptoms in adults with irritable bowel syndrome: A pilot study. Neurogastroenterol Motil. 2022 May;34(5):e14275. doi: 10.1111/nmo.14275. Epub 2021 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'Adults with irritable bowel syndrome (IBS) are being randomized to a yogic breathing or control condition. Participants randomized to the yogic breathing group will be asked to complete a 2-minute yogic breathing video 5 to 7 days per week at home for 4 weeks and control group participants will be asked to maintain their current activities. Participants in this group will be given access to the yogic breathing video at the end of the 4-week control period. IBS symptoms and autonomic and vascular function will be assessed at baseline and at the end of week 4 in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a formal diagnosis of IBS and not be enrolled in any other clinical trials.\n\nExclusion Criteria:\n\n* 1\\) current, regular practice of yogic breathing at least 5 minutes per day and 2) chronic obstructive pulmonary disease'}, 'identificationModule': {'nctId': 'NCT04225104', 'briefTitle': 'Yogic Breathing and IBS', 'organization': {'class': 'OTHER', 'fullName': 'Texas State University'}, 'officialTitle': 'Effects of Yogic Breathing on Microvascular Endothelial Function and Symptoms in Participants With IBS', 'orgStudyIdInfo': {'id': '6275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yogic breathing intervention', 'description': 'Participants assigned to this group will complete a 20-minute yogic breathing video at least 5 days per week for 4 weeks. All sessions except the initial yogic breathing session will be completed at home. Participants will complete the first session at Texas State under the supervision of the investigative team for familiarization.', 'interventionNames': ['Behavioral: Yogic breathing intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in the control group will be asked to maintain their current daily activities and will be given access to the yogic breathing video once all follow-up testing has been completed at the end of week 4.'}], 'interventions': [{'name': 'Yogic breathing intervention', 'type': 'BEHAVIORAL', 'description': 'Yogic breathing will be completed while following a video provided by the investigative team. Breathing practices consist of slow, deep, relaxation breathing and are led by a certified yoga instructor.', 'armGroupLabels': ['Yogic breathing intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78666', 'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'Stacy Hunter', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}], 'overallOfficials': [{'name': 'Stacy D Hunter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}