Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT04845802
Status:
UNKNOWN
Last Update Posted:
2021-04-15
First Post:
2021-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001265', 'term': 'Athletic Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-13', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of baseline postural stability test score in Biodex Balance System after 8 weeks', 'timeFrame': 'Eight weeks', 'description': "The Postural Stability Test evaluates static balance of participants. Postural Stability Test emphasizes a patient's ability to maintain center of balance. The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score."}, {'measure': 'Change of baseline athlete single leg stability score in Biodex Balance System after 8 weeks', 'timeFrame': 'Eight weeks', 'description': "The test protocol for the Athlete Single Leg Stability Testing allows clinicians to test athletes against data derived from studies using the Biodex Balance System. The stability level will challenge athletes and provide the data necessary to assess the athlete's single leg postural stability."}, {'measure': 'Change of baseline limits of stability test score in Biodex Balance System after 8 weeks', 'timeFrame': 'Eight weeks', 'description': 'Limits of stability test evaluates dynamic balance of participants. Biodex balance system measures limits of stability for forward, backward, right and left side movements. It will calculate the maximum distance a person can lean without losing balance.'}, {'measure': 'Change of baseline diaphragm thickness after 8 weeks', 'timeFrame': 'Eight weeks', 'description': 'Two-dimensional B-mode ultrasound will be measure diaphragm thickness at the zone of apposition during inspiration or expiration using the intercostal approach. Diaphragm thickness will be measure as the vertical distance between the pleural and peritoneal layer at both Total Lung Capacity \\[TLC\\] and Functional Residual Capacity \\[FRC\\]. Measurements will be perform on the right hemidiaphragm with the volunteer in the supine position. All measurements will be perform 3 times and the average value for each calculate.'}, {'measure': 'Change of baseline maximum inspiratory pressure after 8 weeks', 'timeFrame': 'Eight weeks', 'description': 'Maximum inspiratory pressure (MIP) will be measure using a hand-held mouth pressure device. Three maximal manoeuvres will perform and the highest value record. Indirect measure of respiratory (inspiratory) muscle strength, expressed in cmH20.'}, {'measure': 'Change of baseline maximum expiratory pressure after 8 weeks', 'timeFrame': 'Eight weeks', 'description': 'Maximum expiratory pressure (MEP) will be measure using a hand-held mouth pressure device. Three maximal manoeuvres will perform and the highest value record. Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20.'}], 'secondaryOutcomes': [{'measure': 'Change of baseline biering-sorenson test score after 8 weeks', 'timeFrame': 'Eight weeks'}, {'measure': 'Change of baseline oswestry disability index after 8 weeks', 'timeFrame': 'Eight weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inspiratory Muscle Training', 'Diaphragm', 'Respiratory Muscle Strength', 'Balance', 'Dancer'], 'conditions': ['Athletic Injuries']}, 'referencesModule': {'references': [{'pmid': '24870567', 'type': 'BACKGROUND', 'citation': 'Janssens L, McConnell AK, Pijnenburg M, Claeys K, Goossens N, Lysens R, Troosters T, Brumagne S. Inspiratory muscle training affects proprioceptive use and low back pain. Med Sci Sports Exerc. 2015 Jan;47(1):12-9. doi: 10.1249/MSS.0000000000000385.'}, {'pmid': '31074198', 'type': 'BACKGROUND', 'citation': 'Ferraro FV, Gavin JP, Wainwright T, McConnell A. The effects of 8 weeks of inspiratory muscle training on the balance of healthy older adults: a randomized, double-blind, placebo-controlled study. Physiol Rep. 2019 May;7(9):e14076. doi: 10.14814/phy2.14076.'}, {'pmid': '28217414', 'type': 'BACKGROUND', 'citation': 'Watson T, Graning J, McPherson S, Carter E, Edwards J, Melcher I, Burgess T. DANCE, BALANCE AND CORE MUSCLE PERFORMANCE MEASURES ARE IMPROVED FOLLOWING A 9-WEEK CORE STABILIZATION TRAINING PROGRAM AMONG COMPETITIVE COLLEGIATE Dancers. Int J Sports Phys Ther. 2017 Feb;12(1):25-41.'}]}, 'descriptionModule': {'briefSummary': 'Dance is a performing art form consisting of sports and art intertwined and complex dynamic choreographic figures were handled aesthetically and physically of narrative. Scientific studies are insufficient on dance and health and performance of dancers in the literature although dance is the most used type of art and sport in all societies and for all age groups. It is seen that the core stabilization (central forces) of the dancers is insufficient when the current studies were examined, this insufficient stabilization causes biomechanical changes in the trunk, and indirectly affects the lower extremities. Consequently, insufficient stabilization was shown to be caused impairment of force generation and injuries. In addition, lack of core stabilization of dancers may cause impairment in balance and postural control. Therefore, dancers need a good postural control with provided by an effective core stabilization training in order to exhibit a successful and healthy performance. It is shown that inspiratory muscle training (IMT) improves diaphragm strength and diaphragm thickness. Considering the relation between diaphragm muscle forming the upper (ceiling) part of the core area, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength and diaphragm thickness in dancers. Thus, the aim of this study was to investigate the effects of inspiratory muscle training on diaphragm thickness, postural stability, balance, respiratory muscle strength in dancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dancer (for least two years)\n* Stable clinical condition (no injury in last 2 months)\n\nExclusion Criteria:\n\n* Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility\n* Having of chronic pulmonary disease'}, 'identificationModule': {'nctId': 'NCT04845802', 'briefTitle': 'Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.', 'orgStudyIdInfo': {'id': 'Iuhaksu01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training Group', 'description': 'Dancers in this group will perform inspiratory muscle training for 30 breaths, twice daily \\[morning: between 7:00 and 13:00 and evening: between 16:00 and 22:00\\], 7 days per week for 8 weeks, with a breathing frequency of 15 breaths per minute and a duty cycle of 0.5. One exercise session will be supervised in a clinic per week, other sessions will be performed at home in every week during the training.', 'interventionNames': ['Other: Inspiratory muscle training(high-IMT group)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group', 'description': 'Dancers in this group will perform inspiratory muscle training for 30 breaths, twice daily \\[morning: between 7:00 and 13:00 and evening: between 16:00 and 22:00\\], 7 days per week for 8 weeks, with a breathing frequency of 15 breaths per minute and a duty cycle of 0.5. One exercise session will be supervised in a clinic per week, other sessions will be performed at home in every week during the training.', 'interventionNames': ['Other: Inspiratory muscle training(low-IMT group)']}], 'interventions': [{'name': 'Inspiratory muscle training(high-IMT group)', 'type': 'OTHER', 'otherNames': ['[high-IMT group]'], 'description': 'A mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training. Training intensity will set at 60% of the maximum inspiratory pressure.', 'armGroupLabels': ['Training Group']}, {'name': 'Inspiratory muscle training(low-IMT group)', 'type': 'OTHER', 'otherNames': ['[low-IMT group]'], 'description': 'Dancers will be perform at a load setting of level 1 (corresponding to \\~10% baseline MIP), using the same device as the training group.', 'armGroupLabels': ['Sham Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hakan Aksu', 'role': 'CONTACT', 'email': 'fizyoterapistha@gmail.com', 'phone': '5332165106', 'phoneExt': '+90'}], 'overallOfficials': [{'name': 'Sensu Dincer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University Faculty of Medicine Sports Medicine Department'}, {'name': 'Turker Sahinkaya, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University Faculty of Medicine Sports Medicine Department'}, {'name': 'Bulent Bayraktar, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University Faculty of Medicine Sports Medicine Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Patients may not want to share the data with anyone other than the researchers involved in the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, MSc Student in Exercise Physiology', 'investigatorFullName': 'Hakan Aksu', 'investigatorAffiliation': 'Istanbul University'}}}}