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Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.

Primary Purpose

Athletic Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inspiratory muscle training(high-IMT group)
Inspiratory muscle training(low-IMT group)
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Athletic Injuries focused on measuring Inspiratory Muscle Training, Diaphragm, Respiratory Muscle Strength, Balance, Dancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Dancer (for least two years)
  • Stable clinical condition (no injury in last 2 months)

Exclusion Criteria:

  • Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
  • Having of chronic pulmonary disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Training Group

    Sham Group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Change of baseline postural stability test score in Biodex Balance System after 8 weeks
    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.
    Change of baseline athlete single leg stability score in Biodex Balance System after 8 weeks
    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.
    Change of baseline limits of stability test score in Biodex Balance System after 8 weeks
    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.
    Change of baseline diaphragm thickness after 8 weeks
    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.
    Change of baseline maximum inspiratory pressure after 8 weeks
    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.
    Change of baseline maximum expiratory pressure after 8 weeks
    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.

    Secondary Outcome Measures

    Change of baseline biering-sorenson test score after 8 weeks
    Change of baseline oswestry disability index after 8 weeks

    Full Information

    First Posted
    April 12, 2021
    Last Updated
    April 13, 2021
    Sponsor
    Istanbul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04845802
    Brief Title
    Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.
    Official Title
    Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    October 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Athletic Injuries
    Keywords
    Inspiratory Muscle Training, Diaphragm, Respiratory Muscle Strength, Balance, Dancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Training Group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Sham Group
    Arm Type
    Sham Comparator
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Inspiratory muscle training(high-IMT group)
    Other Intervention Name(s)
    [high-IMT group]
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Inspiratory muscle training(low-IMT group)
    Other Intervention Name(s)
    [low-IMT group]
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Change of baseline postural stability test score in Biodex Balance System after 8 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.
    Time Frame
    Eight weeks
    Title
    Change of baseline athlete single leg stability score in Biodex Balance System after 8 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.
    Time Frame
    Eight weeks
    Title
    Change of baseline limits of stability test score in Biodex Balance System after 8 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.
    Time Frame
    Eight weeks
    Title
    Change of baseline diaphragm thickness after 8 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.
    Time Frame
    Eight weeks
    Title
    Change of baseline maximum inspiratory pressure after 8 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.
    Time Frame
    Eight weeks
    Title
    Change of baseline maximum expiratory pressure after 8 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.
    Time Frame
    Eight weeks
    Secondary Outcome Measure Information:
    Title
    Change of baseline biering-sorenson test score after 8 weeks
    Time Frame
    Eight weeks
    Title
    Change of baseline oswestry disability index after 8 weeks
    Time Frame
    Eight weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Dancer (for least two years) Stable clinical condition (no injury in last 2 months) Exclusion Criteria: Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility Having of chronic pulmonary disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hakan Aksu
    Phone
    5332165106
    Ext
    +90
    Email
    fizyoterapistha@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sensu Dincer, Dr.
    Organizational Affiliation
    Istanbul University Faculty of Medicine Sports Medicine Department
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Turker Sahinkaya, Lecturer
    Organizational Affiliation
    Istanbul University Faculty of Medicine Sports Medicine Department
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Bulent Bayraktar, Prof. Dr.
    Organizational Affiliation
    Istanbul University Faculty of Medicine Sports Medicine Department
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Patients may not want to share the data with anyone other than the researchers involved in the study.
    Citations:
    PubMed Identifier
    24870567
    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.
    Results Reference
    background
    PubMed Identifier
    31074198
    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.
    Results Reference
    background
    PubMed Identifier
    28217414
    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.
    Results Reference
    background

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    Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.

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