Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-26 @ 7:17 AM
Study NCT ID:
NCT06230692
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2024-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm Structure and Function in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-01-19', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '6-minute walk test distance (measured in m)', 'timeFrame': '6 weeks', 'description': 'Maximal distance walked in 6 minutes'}], 'primaryOutcomes': [{'measure': 'Percent completion', 'timeFrame': '6 weeks', 'description': 'Percentage of enrolled participants who complete the 6-week inspiratory muscle training protocol'}, {'measure': 'Adherence to treatment protocol', 'timeFrame': '6 weeks', 'description': 'Number of sets and repetitions of training breaths completed during the 6-week inspiratory muscle training protocol'}], 'secondaryOutcomes': [{'measure': 'Maximal inspiratory pressure (measured in cm H2O)', 'timeFrame': '6 weeks', 'description': 'Maximal pressure generated during an inspiratory maneuver, representing inspiratory muscle strength'}, {'measure': 'Diaphragm thickness (measured in mm)', 'timeFrame': '6 weeks', 'description': 'Thickness of the diaphragm muscle measured by noninvasive ultrasound imaging'}, {'measure': 'Exercise ventilation', 'timeFrame': '6 weeks', 'description': 'Ratio of ventilation to carbon dioxide production (VE/VCO2) during steady-state walking, representing ventilatory drive during exercise'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diaphragm', 'Control of Breathing', 'Exercise'], 'conditions': ['Respiratory Muscle Training']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children.', 'detailedDescription': 'During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range 6-12 years of age\n\nExclusion Criteria:\n\n* History of neuromuscular, cardiac, or pulmonary disease\n* Known intellectual or developmental problems that would preclude the ability to assent\n* Ruptured eardrum\n* Recent injury or condition (less than 6 months ago) that precludes strength testing or walking\n* Recent (less than 2 weeks ago) or current respiratory or other type of illness'}, 'identificationModule': {'nctId': 'NCT06230692', 'briefTitle': 'Diaphragm Structure and Function in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Understanding the Influence of Diaphragm Structure and Function on the Control of Breathing During Exercise in Children', 'orgStudyIdInfo': {'id': 'HP-00108839'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inspiratory Muscle Training (IMT)', 'description': 'Participants will be asked to perform inspiratory muscle training (breathing exercise) 5 days per week for 6 weeks at home.', 'interventionNames': ['Device: POWERbreathe Plus IMT']}], 'interventions': [{'name': 'POWERbreathe Plus IMT', 'type': 'DEVICE', 'description': "Inspiratory muscle training will be performed using the POWERbreathe Plus IMT (POWERbreathe International Ltd., Warwickshire, UK), a commercially available inspiratory pressure threshold device. In this type of training, airflow is occluded until the generated inspiratory pressure reaches the predetermined threshold, which can be set at increments of 8 cm H2O.\n\nDuring the first week of training, the target intensity will be set at 50% of baseline maximal inspiratory pressure (MIP.) During the second week, the target intensity will be set at 60% of baseline MIP. Beginning at the third week and for the remainder of the training program, the target intensity will be set at 75% of the participant's baseline MIP. The target volume will be 5 sets of 6 breaths per day (total of 30 breaths per day), separated by 1-minute rest breaks between sets. The frequency of training will be 5 days per week, for a duration of 6 weeks.", 'armGroupLabels': ['Inspiratory Muscle Training (IMT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Maryland, Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Martina Miller', 'role': 'CONTACT', 'email': 'martina.miller@umaryland.edu', 'phone': '410-706-3869'}], 'overallOfficials': [{'name': 'Simon Ho', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Simon Ho', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}